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SPONSOR: Sen. Poore & Rep. Kamela Smith
Sens. Brown, Buckson, Cruce, Hansen, Hocker, Hoffner,
Huxtable, Lawson, Lockman, Mantzavinos, Paradee,
Pettyjohn, Pinkney, Richardson, Seigfried, Sokola,
Sturgeon, Townsend, Walsh, Wilson
DELAWARE STATE SENATE
153rd GENERAL ASSEMBLY
SENATE BILL NO. 180
AN ACT TO AMEND CHAPTER 25, TITLE 24 OF THE DELAWARE CODE RELATING TO THE BOARD OF
PHARMACY.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:
1 Section 1. Amend Chapter 25, Title 24 of the Delaware Code by making deletions as shown by strike through and
2 insertions as shown by underline as follows:
3 § 2501. Objectives of the Board.
4 The primary objective of the Board of Pharmacy is to promote, preserve, and protect the public health, safety, and
5 welfare. In meeting this objective, the Board shall develop and maintain a registry of drug outlets engaged in the
6 manufacture, production, sale, and distribution of drugs, medications, and such other materials as may be used in the
7 diagnosis and prevention of illness and disease and in the treatment of injury, and shall monitor the outlets to insure safe
8 practices. The secondary objective of the Board is to maintain minimum standards of professional competency in the
9 practice of pharmacy.
10 In meeting its objectives, the Board shall develop standards assuring professional competence; shall monitor
11 complaints brought against pharmacists regulated by the Board; shall adjudicate at formal complaint hearings; shall
12 promulgate rules and regulations; and shall impose sanctions, where necessary, against pharmacists. This chapter must be
13 liberally construed to carry out these objectives.
14 (a) The primary objective of the Board of Pharmacy, to which all other objectives and purposes are secondary, is
15 to protect the general public, specifically those individuals who are the direct recipients of services regulated by this
16 chapter, from unsafe practices and from occupational practices which reduce competition or fix the price of services
17 rendered.
18 (b) The secondary objectives of the Board are to maintain minimum standards of licensee competency and to
19 maintain certain standards in the delivery of services to the public. In meeting these objectives, the Board shall do all of the
20 following:
21 (1) Develop standards assuring professional competence.
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22 (2) Monitor complaints brought against licensees regulated by the Board.
23 (3) Adjudicate at formal hearings.
24 (4) Promulgate rules and regulations.
25 (5) Impose sanctions where necessary.
26 § 2502. Definitions.
27 For purposes of this chapter:
28 (1) “Administer” means the direct application of a prescription drug, whether by injection, inhalation, ingestion, or
29 any other means, to the body of a patient by any of the following:
30 a. An individual authorized by law to administer the drug, including a practitioner or an authorized agent
31 under a practitioner’s supervision.
32 b. The patient at the direction of a practitioner.
33 (2) “Biological product” means a biological product as defined in § 351 of the Public Health Service Act (42
34 U.S.C. § 262) 42 U.S.C. § 262.
35 (2) (3) “Board,” “Board of Pharmacy,” or “State Board of Pharmacy” means the Delaware State Board of
36 Pharmacy.
37 (3) (4) “Certified pharmacy technician” means a person an individual who is certified by the Pharmacy Technician
38 Certification Board (PTCB) or other entity approved by the Board of Pharmacy.
39 (4) (5) “Collaborative pharmacy practice” means the practice of pharmacy whereby 1 or more pharmacists
40 provides patient care and drug therapy management services not otherwise permitted to be performed by a pharmacist to
41 patients under a collaborative pharmacy practice agreement(s) agreement with 1 or more practitioners which defines the
42 nature, scope, conditions, and limitations of the services to be provided by the pharmacist(s) pharmacist.
43 (5) (6) “Collaborative pharmacy practice agreement” means a written and signed agreement between 1 or more
44 pharmacists and 1 or more practitioners that provides for collaborative pharmacy practice.
45 (7) “Compounding” means the preparation, assembling, packaging, or labeling of a drug as the result of a
46 practitioner’s prescription or initiative based on the relationship of the practitioner or patient with the pharmacist in the
47 course of professional practice or for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale
48 or dispensing. Compounding also includes the preparation of drugs in anticipation of prescription drug orders based on
49 routine, regularly observed prescribing patterns. All compounding must comply with applicable United States
50 Pharmacopeia (“USP”) standards. Nothing in this title is meant to limit a prescriber’s ability under pre-existing law to order
51 a compounded medication for use in the prescriber’s practice, as permitted by State and federal law.
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52 (8) “Controlled substance” means any drug designated as such under the Uniform Controlled Substances Act,
53 Chapter 47, Title 16 of the Delaware Code and 21 Code of Federal Regulations, Part 1308.
54 (9) “Deliver” or “deliver” means the actual, constructive, or attempted transfer of a drug from one person to
55 another, whether or not for consideration.
56 (6) (10) “Direct supervision” means oversight and control by a licensed pharmacist who remains on the premises
57 in the licensed establishment where the pharmacy department is located and is responsible for the work performed by a
58 subordinate support personnel.
59 (7) (11) “Dispense” or “dispensing” means the procedure involving the interpretation of a practitioner’s
60 prescription order for a drug or biological, and pursuant to that order the proper selection, measuring, compounding,
61 labeling, and packaging in a proper container for subsequent administration to, or use by, a patient means to furnish or
62 deliver a drug to an ultimate user by or pursuant to the lawful prescription of a practitioner. Dispense includes the
63 preparation, packaging, labeling, or compounding necessary to prepare a drug for furnishing or delivery.
64 (8) (12) “Division” means the Division of Professional Regulation.
65 (9) (13) “Drug” means any of the following:
66 a. A substance recognized as a drug in the Official United States Pharmacopoeia/National Formulary;
67 Formulary.
68 b. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of any illness,
69 condition, or disease in humans or animals; animals.
70 c. A substance, other than food, intended to affect the structure or any function of the body of a human or
71 an animal; or animal.
72 d. A substance intended for use as a component of any substance specified in paragraph (8)a., b. or c.se
73 paragraph a., b., or c., of this section subsection.
74 “Drug” does not include devices or their components, parts, or accessories.
75 (10) “Drug outlet” means a pharmacy, an in-state or out-of-state drug wholesaler, a drug manufacturer, a drug
76 distributor, or a nonpharmacy veterinary drug seller.
77 (11) (14) “Executive Secretary” means the executive secretary of the Delaware State Board of Pharmacy Board,
78 who shall must be a pharmacist.
79 (12) (15) “Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence
80 Evaluations” means the publication with that title containing a list of prescription drugs by generic name. that identifies
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81 drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic
82 Act. This is sometimes referred to as the “Orange Book.”
83 (13) (16) “Interchangeable” means a biological product licensed by the Federal Food and Drug Administration
84 pursuant to 42 U.S.C. § 262(k)(4) 262.
85 (14) (17) “Intern” means a person an individual who is registerewd licensed by the Board of Pharmacy and
86 supervised by an approved preceptor and who is completing the practical experience requirement of the Board prior to that
87 person’s licensure as a pharmacist.
88 (15) (18) “Internship” or “externship” means a period of practical experience established by Board of Pharmacy
89 the Board’s rules and regulations regulation that must be completed by an applicant for a license to practice pharmacy in
90 this State.
91 (19) “Key personnel” means the designated representative or most senior individual responsible for facility
92 operations, purchasing, and inventory control, the supervisor of such individual, and, if the establishment is not a publicly
93 held company, all principals and owners who directly or indirectly own more than 10% interest in the establishment.
94 (20) “Label” means written, printed, or graphic matter on the immediate container of a drug.
95 (21) “Labeling” means the process of affixing a label, including all information required by federal and state
96 statutes or rules and regulations, to a drug container. The term does not include any of the following:
97 a. The labeling by a manufacturer or distributor of a nonprescription drug or commercially packaged
98 prescription drug.
99 b. Unit dose packaging.
100 (16) (22) “Manufacturer” means a person who is engaged in manufacturing, preparing, propagating, compounding,
101 processing, packaging, repackaging, or labeling of a drug, but does not include a person who is engaged in the preparation
102 and dispensing of a drug pursuant to a prescription.
103 (23) “Manufacturing” means the production, preparation, propagation, conversion, or processing of a drug, either
104 directly or indirectly, by extraction from a substance of natural origin or independently by a chemical or biological
105 synthesis. The term includes packaging or repackaging a substance or labeling or relabeling a container and promoting and
106 marketing the drug and preparing and promoting a commercially available product from a bulk compound for resale by a
107 person, including a pharmacy or practitioner. The term does not include compounding.
108 (17) (24) “Monitoring drug therapy” means interpreting and analyzing information needed to evaluate the safety
109 and efficacy of drug therapy.
110 (25) “NABP” means the National Association of Boards of Pharmacy or its successor.
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111 (26) “Outsourcing facility” means a facility that meets all of the following:
112 a. Is located within the United States of America at one address that is engaged in the compounding of
113 sterile drugs or nonsterile drugs.
114 b. Has registered as an outsourcing facility with the Food and Drug Administration under § 503B of the
115 Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 353b).
116 c. Is doing business within or into Delaware.
117 d. Is licensed with the Board as a wholesaler prior to applying to the Board to become an outsourcing
118 facility.
119 e. Is licensed with the Board as an outsourcing facility.
120 (18) (27) “Over-the-counter product” or “OTC” means a substance which may be sold without a prescription and
121 which is packaged for use by the consumer and labeled in accordance with the requirements of state and federal statutes and
122 regulations.
123 (28) “Patient counseling” means communication by a pharmacist, or registered intern or pharmacy student under
124 direct supervision, of pertinent drug information, as specified by the Board’s rules and regulations, to a patient or caregiver
125 to improve therapy.
126 (19) “Person” means a natural person or an entity.
127 (29) “Person” means as defined in § 302 of Title 1.
128 (20) (30) “Pharmacist” or “licensee” means an individual licensed by the State pursuant to this chapter to engage
129 in the practice of pharmacy.
130 (21) (31) “Pharmacy” means a place where drugs are compounded or dispensed the practice of pharmacy occurs.
131 (22) (32) “Pharmacy technician” means an individual who is not registered as an intern with the Board of
132 Pharmacy or a certified pharmacy technician working in a pharmacy practice site who, under the immediate supervision of
133 a pharmacist, assists in pharmacy activities, as permitted by the rules and regulations of the Board, that do not require the
134 professional judgment of a pharmacist.
135 (23) (33) “Practice of pharmacy” means the interpreting, evaluating, and dispensing of a practitioner’s or
136 prescriber’s order. The “practice of pharmacy” includes the proper compounding, labeling, packaging, and dispensing of a
137 drug to a patient or the patient’s agent, and administering a drug to a patient. The “practice of pharmacy” includes the
138 application of the pharmacist’s knowledge of pharmaceutics, pharmacology, pharmacokinetics, drug and food interactions,
139 drug product selection, and patient counseling. The “practice of pharmacy” also includes all of the following:
140 a. Participation in drug utilization and/or or drug regimen reviews.
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141 b. Participation in therapeutic drug selection, substitution of therapeutically equivalent drugproducts drug
142 products.
143 c. Advising practitioners and other health-care professionals, as well as patients, regarding the total scope
144 of drug therapy, so as to deliver the best care possible.
145 d. Monitoring drug therapy.
146 e. Performing and interpreting capillary blood tests to screen and monitor disease risk factors or facilitate
147 patient education, the results of which must be reported to the patient’s health-care practitioner; screening
148 practitioner. Screening results to must be reported only if outside normal limits.
149 f. Conducting or managing a pharmacy or other business establishment where drugs are compounded or
150 dispensed.
151 g. [Repealed.]
152 h. Administration of injectable medications, biologicals, and immunizations pursuant to a valid
153 prescription from a practitioner or practitioner-approved protocol approved by a physician duly licensed in the
154 State under subchapter III of Chapter 17 of this title or a nurse duly licensed in the State under Chapter 19 of this
155 title. Upon request, a copy of the protocol will be made available to the designated prescriber or prescribers
156 without cost. All vaccine administrations shall be reported to DelVAX within 72 hours of administration. This
157 report to DelVAX shall include the patient’s name, the name of the immunization, inoculations, or vaccinations
158 administered, site of injection, lot and expiration, the facility that provided vaccination, and the date of
159 administration, and shall be submitted electronically. Pharmacists, pharmacy interns, and nationally-certified
160 pharmacy technicians who have completed an accredited training program, are currently trained in CPR, and have
161 notified the Delaware Board of Pharmacy, may administer immunizations via a prescriber’s order or protocol for
162 patients 3 years of age and older.
163 i. Dispensing contraceptives or dispensing and administering injectable hormonal contraceptives under
164 Chapter 30O of Title 16.
165 j. Ordering, performing, and interpreting tests authorized by the Food and Drug Administration, and
166 waived under the federal Clinical Laboratory Improvement Amendments of 1988 [42 U.S.C. § 263a].
167 k. Initiating drug therapy for health conditions in accordance with § 2525 of this title.
168 l. Collaborative pharmacy practice in accordance with a collaborative pharmacy practice agreement.
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169 m. Initiating, dispensing, or administering medications for human immunodeficiency virus (HIV) pre-
170 exposure prophylaxis and HIV post-exposure prophylaxis under § 2525A of this title, which includes
171 administering laboratory tests, conducting assessments and consultations, and providing referrals.
172 (24) (34) “Practitioner” or “prescriber” means an individual who is authorized by law to prescribe drugs in the
173 course of professional practice or by collaborative pharmacy practice agreement or research in any state.
174 (25) (35) “Practitioner-dispensed medication” means a drug that is all of the following:
175 a. Dispensed by a practitioner to a patient.
176 b. A topical antibiotic, anti-inflammatory, dilation, or glaucoma drop or ointment.
177 c. On stand-by or retrieved from a dispensing system for a specified patient for use during a procedure or
178 visit with the practitioner.
179 (26) (36) “Preceptor” means a licensed pharmacist who is approved by the Board to supervise an intern an
180 individual who is a pharmacist, meets the qualifications under the rules and regulations of the Board, and participates in the
181 instructional training of pharmacy interns and externs.
182 (27) (37) “Prescription drug” or “legend drug” means a drug required by federal or state law or regulation to be
183 dispensed only by a prescription, including finished dosage forms and active ingredients, subject to § 503(b) 503B of the
184 Federal Food, Drug and Cosmetic Act (21 U.S.C. § 353(b)).
185 (28) (38) “Prescription drug order” or “prescription” means the lawful written or verbal order of a practitioner for
186 a drug authorization for a drug by a licensed practitioner in written, verbal, electronic, or fax format and must include the
187 information set forth in the Board’s rules and regulations.
188 (29) (39) “Reference product” means a product as defined by the Federal Food and Drug Administration pursuant
189 to 42 U.S.C. § 262.
190 (30) (40) “State” means the State of Delaware.
191 (31) (41) “Substantially related” means the nature of the criminal conduct, for which the person was convicted, has
192 a direct bearing on the fitness or ability to perform 1 or more of the duties or responsibilities necessarily related to the
193 practice of pharmacy.
194 (32) (42) “Substitution” or “substitute” means means a pharmacist’s selection of prescriber authorized generic or
195 therapeutically equivalent prescription medications or, in the case of biologicals, pharmacist a pharmacist’s selection of an
196 interchangeable biological product in place of the prescribed product. Generic substitution substitute means a drug that is
197 the same active ingredient, equivalent in strength to the strength written on the prescription prescription, and which is
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198 classified as being therapeutically equivalent to another drug in the latest edition or supplement of the Federal Food and
199 Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, sometimes referred to as
200 the “Orange Book.”
201 (33) (43) “Therapeutically equivalent drug” means a drug which contains the same active ingredient or ingredients
202 and is identical in strength or concentration, dosage form, and route of administration and which is classified as being
203 therapeutically equivalent to another drug in the latest edition or supplement of the Federal Food and Drug Administration
204 (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, Evaluations, sometimes referred to as the
205 Orange Book.
206 (34) “Use or abuse of drugs” means:
207 a. The use of illegal drugs;
208 b. The use of prescription drugs without a prescription; or
209 c. The excessive use or abuse of alcoholic beverage or drugs to the extent that it impairs a pharmacist’s
210 ability to perform the work of a pharmacist.
211 (35) (44) “Wholesale distribution” means the distribution of drugs in compliance with federal laws and
212 regulations, including the Drug Supply Chain Security Act, to a person other than a consumer or patient. Wholesale
213 distribution patient but does not include any of the following:
214 a. The distribution of drugs within a healthcare group-purchasing organization; organization.
215 b. The transfer of prescription drugs by a pharmacy to another pharmacy to alleviate a temporary
216 shortage; shortage.
217 c. The dispensing of a drug pursuant to a prescription; or prescription.
218 d. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug under any of the
219 following circumstances:
220 1. By a charitable organization described in § 501(c)(3) of the Internal Revenue Code of 1954 (26
221 U.S.C. § 501(c)(3)) to a nonprofit affiliate of the charitable organization to the extent permitted by law; law.
222 2. Among hospitals or other health care entities which are under common control; control.
223 3. For emergency medical reasons.
224 (36) (45) “Wholesale distributor” “Wholesaler” means a person engaged in the wholesale distribution of drugs,
225 including, but not limited to, a manufacturer’s or distributor’s warehouse, a chain drug warehouse or wholesale drug
226 warehouse, an independent wholesale drug trader, and a pharmacy that engages in the wholesale distribution of drugs.
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227 § 2503. Board of Pharmacy; appointments; composition; qualifications; terms; vacancies; suspension or removal;
228 unexcused absences; compensation.
229 (a) The Delaware State Board of Pharmacy shall administer and enforce this chapter.
230 (b) The Board consists of 9 members who are appointed by the Governor and Governor, who are residents of the
231 State. State, and who are comprised as follows:
232 (1) Six members are pharmacists who have been engaged in the practice of pharmacy in Delaware for at
233 least 5 years and who are representative of the various practice settings in the field of pharmacy.
234 (2) Three members are public members, 1 from each county. A public member member:
235 a. may May not be, nor ever have been, a pharmacist or a member of the immediate family of a
236 pharmacist; pharmacist.
237 b. may May not be, nor ever have been, employed by a pharmacy; pharmacy.
238 c. may May not have a material interest in the providing of goods or services to a pharmacy;
239 pharmacy. and may
240 d. May not be, nor ever have been, engaged in an activity directly related to the practice of pharmacy.
241 A public member must
242 e. Must be accessible to inquiries, comments, and suggestions from the general public.
243 (c) Except as provided in subsection (d) of this section, each Board member serves a term of 3 years, and may
244 succeed oneself for 1 additional term; provided, however, that where a member was initially appointed to fill a vacancy, the
245 member may succeed oneself for only 1 additional full term. A person appointed to fill a vacancy on the Board holds office
246 for the remainder of the unexpired term of the vacating member. Each term of office expires on the date specified in the
247 appointment; however, a Board member whose appointment has expired remains eligible to participate in Board
248 proceedings unless or until replaced by the Governor. Members must be appointed so that the terms of no more than 3
249 members expire in any 1 year. A person who is a member of the Board on July 24, 2007, may complete that person’s own
250 term. Each member is appointed for a term of 3 years and may serve 2 additional, successive terms. Each term of office
251 expires on the date specified in the appointment; however, a member remains eligible to participate in Board proceedings
252 until the Governor replaces that member.
253 (d) A person who has never served on the Board may be appointed to the Board for 2 for 3 consecutive terms; but
254 that person is thereafter ineligible to serve for 2 consecutive appointments. A person who has been twice appointed to the
255 Board or who has served on the Board for 6 years within any 9-year period may not again be appointed to the Board until
256 an interim period of at least 1 term has expired since the person last served.
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257 (e) An act or vote on Board business by a person appointed to the Board in violation of this section is invalid.
258 (f) The Governor shall suspend or remove a member of the Board for the member’s misfeasance, nonfeasance,
259 malfeasance, misconduct, incompetency, or neglect of duty. A member subject to a disciplinary hearing must be
260 disqualified from Board business until the charge is adjudicated or the matter is otherwise concluded. A Board member
261 may appeal to the Superior Court a suspension or removal initiated pursuant to this subsection.
262 (g) A member of the Board, while serving on the Board, may not hold elective office in any professional
263 association of pharmacists or serve as an officer of a professional association’s political action committee (PAC).
264 (h) The provisions of the State Employees’, Officers’ and Officials’ Code of Conduct set forth in Chapter 58 of
265 Title 29 apply to the members of the Board.
266 (i) A member who is absent without adequate reason for 3 consecutive regular business meetings or who fails to
267 attend at least 1/2 of all regular business meetings during any calendar year is guilty of neglect of duty.
268 (j) Each member of the Board shall be reimbursed for all expenses involved in each meeting, including travel, and
269 in addition shall receive compensation per meeting attended in an amount determined by the Division in accordance with
270 Del. Const. art. III, § 9.
271 (k) The Pharmacy Regulatory Council shall fall under the authority of the Board of Medical Licensure and
272 Discipline and shall consist of 4 pharmacists and 1 member of the public appointed by the Board of Pharmacy, and 2
273 physicians appointed by the Board of Medical Licensure and Discipline. One of the physicians shall serve as chairperson of
274 the Council. Regulations applicable to activities described in § 2502(21)h. of this title must be approved by the Council.
275 § 2504. Organization; meetings; officers; quorum; Executive Secretary.
276 (a) The Board shall elect annually from its membership a President and a Vice President. Each officer serves for 1
277 year and may not succeed oneself for more than 2 consecutive terms.
278 (b) The Board shall hold regularly scheduled business meetings at least 6 times in a calendar year, and at other
279 times as the President of the Board considers necessary, and at the request of a majority of the Board members.
280 (b) The Board shall elect annually a president and other officers as it considers appropriate and necessary to
281 conduct business. Each term of office is for 1 year. An officer may not serve for more than 3 consecutive terms in the same
282 office.
283 (c) The Executive Secretary, who is an ex officio member of the Board without a vote, is responsible for the
284 performance of the regular administrative functions of the Board and other duties as the Board may direct.
285 (d) A majority of the members of the Board constitutes a quorum for the purpose of transacting business; however,
286 no disciplinary action may be taken without the affirmative vote of at least 5 members.
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287 (e) Minutes of all meetings must be recorded. The Executive Secretary shall maintain copies of the recorded
288 minutes. At any hearing where evidence is presented, a record from which a verbatim transcript can be prepared must be
289 made. The person requesting a transcript incurs the expense of preparing the transcript.
290 § 2505. Records.
291 The Executive Secretary Division shall must keep complete records relating to meetings of the Board,
292 examinations, rosters of licensees and permit holders, changes and additions to the Board’s rules and regulations,
293 complaints, hearings, and other matters as the Board determines. Records kept in accord with this section are prima facie
294 evidence of the proceedings of the Board.
295 § 2506. Authority of the Board. Powers and duties.
296 (a) The Board of Pharmacy has the authority to:
297 (1) Promulgate rules and regulations not inconsistent with § 2501(a) of this title in accordance with the
298 procedures specified in the Administrative Procedures Act [Chapter 101 of Title 29]; in Chapter 101 of Title 29.
299 (2) Designate the application form to be used by all applicants and to process Process all applications
300 pursuant to this chapter; chapter.
301 (3) Designate the national standardized examinations in pharmacy and jurisprudence as approved by the
302 National Association of Boards of Pharmacy, or its successor, to be taken by a person an individual applying for a
303 license to practice pharmacy; pharmacy.
304 (4) Evaluate the credentials of each person individual applying for a license to practice pharmacy in order
305 to determine whether the person individual meets the qualifications set forth in this chapter; chapter.
306 (5) Grant a license to and renew the license of each person individual who qualifies for a license to
307 practice pharmacy; and grant or renew a license with restrictions, if appropriate, as a reasonable accommodation to
308 an applicant with a disability; licensure and renew licenses as appropriate.
309 (6) Evaluate applications and issue licenses to pharmacies and other establishments that meet the
310 qualifications set forth in this chapter.
311 (6) (7) Establish by regulation continuing education standards required for license renewal; renewal.
312 (8) Perform random audits of continuing education credits submitted by licensees for license renewal.
313 (7) (9) Evaluate certified records, including criminal history records, to determine whether an applicant
314 for licensure who previously has been licensed, certified, or registered in another jurisdiction to practice pharmacy
315 has engaged in any act or offense that would be grounds for disciplinary action under this chapter and whether
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316 there are disciplinary proceedings or unresolved complaints pending against the applicant for such acts or offenses;
317 chapter.
318 (8) Maintain a registry of interns;
319 (9) (10) Refer all complaints from licensees and the public concerning persons licensed under this
320 chapter, or concerning the practices of the Board or the profession, to the Division for investigation pursuant to §
321 8735 of Title 29 and assign a member of the Board to assist the Division in an advisory capacity with the
322 investigation for the technical aspects of the complaint; complaint.
323 (10) Issue subpoenas to require the attendance of persons and the production of books and papers for the
324 purpose of conducting investigations preliminary to hearings and for the purpose of eliciting testimony at hearings.
325 A person who is subpoenaed may be required to testify in any and all matters within the jurisdiction of the Board.
326 Subpoenas may be issued by the Director of the Division of Professional Regulation or the Executive Secretary of
327 the Board and are enforceable by the Superior Court;
328 (11) Conduct hearings and issue orders in accordance with the procedures established in the
329 Administrative Procedures Act in Chapter 101 of Title 29; 29.
330 (12) Designate and impose an appropriate sanction or penalty, if it has been determined after a hearing
331 that a sanction or penalty should be imposed; imposed.
332 (13) Evaluate applications and issue permits to pharmacies or other establishments, as provided under this
333 chapter;
334 (14) (13) Join professional organizations and associations organized exclusively to promote the
335 improvement of the standards of the practice of pharmacy for the protection of the health, safety, and welfare of
336 the public and whose activities assist and facilitate the work of the Board, and pay annual dues to the organizations
337 and associations joined; joined.
338 (15) (14) Regulate the sale and dispensing of drugs and other materials, including the right to seize any
339 drugs and other materials found by the Executive Secretary or other agent of the Board to be detrimental to the
340 public health, safety, or welfare, in accordance with Chapter 33 of Title 16; § 3315 of Title 16.
341 (16) (15) Regulate the purity and quality of drugs and other materials within the practice of pharmacy;
342 pharmacy.
343 (17) (16) Promulgate rules and regulations to implement the law relating to pure drugs, pursuant to §
344 3315 of Title 16; 16.
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345 (18) Appoint public members and pharmacists to the Pharmacy Regulatory Council of the Board of
346 Medical Licensure and Discipline.
347 (17) Seize any drugs found by the Board or Executive Secretary to constitute an imminent danger to the
348 public health and welfare.
349 (18) Establish by rule and regulation minimum specifications for record keeping, prescription and patient
350 profile record maintenance, monitoring of drug therapy, and pharmacy practice sites including the physical
351 premises, technical equipment, environment, supplies, personnel, and procedures for the storage, compounding,
352 and dispensing of drugs.
353 (19) Inspect any pharmacy for the purpose of determining if any provision of the laws governing the legal
354 distribution of drugs or the practice of pharmacy are being violated.
355 (20) Appoint advisory committees as the Board determines to be appropriate.
356 (21) Promulgate a Code of Ethics by rule and regulation.
357 (b) The Board of Pharmacy shall promulgate regulations specifically identifying those crimes, crimes which are
358 substantially related to the practice of pharmacy.
359 (c) The Board shall submit a written report to the Governor within 3 months after the conclusion of each fiscal
360 year and shall make the report available to anyone requesting a copy.
361 Subchapter II. Licensure of pharmacists and interns
362 § 2507. License required.
363 (a) A person An individual may not, in this State, engage in the practice of pharmacy or hold himself or herself
364 oneself out to the public as being qualified to practice pharmacy, or use in connection with that person’s individual’s own
365 name, or otherwise assume or use, a title or description conveying or tending to convey the impression that the person
366 individual is qualified to practice pharmacy, except as provided in this chapter.
367 (b) No person individual who has not been issued a certificate as a pharmacist or who is not a pharmacy intern, or
368 a pharmacy student participating in an approved College of Pharmacy coordinated practical experience program under the
369 direct supervision of a licensed pharmacist, within the meaning of this chapter, shall may certify a prescription, perform
370 drug utilization reviews, provide drug information requiring clinical or technical knowledge, counsel patients, receive new
371 verbal prescription orders without recorded backup, or contact a prescriber concerning prescription drug order interpretation
372 or therapy modification. Other responsibilities may be delegated to a certified pharmacy technician or pharmacy technicians
373 who are under the direct supervision of a pharmacist.
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374 (c) It is unlawful for a person an individual to practice pharmacy in this State if the person’s individual’s license to
375 practice pharmacy expires, is placed on inactive status, or is suspended or revoked.
376 (d) The penalty for a violation of this section is, for a first conviction, a fine of not less than $500 nor more than
377 $1000, and for a second or subsequent conviction, a fine of not less than $1000 nor more than $2000.
378 § 2508. Qualifications of applicant; judicial review; report to Attorney General.
379 (a) An applicant for a license to practice pharmacy must submit evidence, verified by oath or affirmation and
380 satisfactory to the Board, that the applicant has completed the requirements for graduation from a school or college of
381 pharmacy accredited by the American Council on Pharmaceutical Education; or, if the applicant is a graduate of a foreign
382 school or college of pharmacy, that the applicant graduated and received a pharmacy degree from a pharmacy degree
383 program which has been approved by the Board.
384 (b) An applicant for a license to practice pharmacy must obtain practical experience in the practice of pharmacy
385 during and/or after attendance at a school or college of pharmacy, under such terms and conditions as the Board determines.
386 The Board shall also determine the necessary qualifications for preceptors used in internships or other programs.
387 (c) The Board shall determine whether an applicant whose conduct or status is described in 1 or more of the
388 following paragraphs of this subsection is qualified to engage in the practice of pharmacy. In making this determination, the
389 Board shall consider whether the applicant’s conduct is or is not related to the practice of pharmacy and whether licensure
390 of the applicant will or will not present a risk to public health, safety, or welfare, and shall conduct its analysis of criminal
391 history records consistent with the provisions of § 8735(x) of Title 29.
392 (1) The applicant received an administrative penalty regarding the practice of pharmacy, including but not
393 limited to fines, formal reprimands, license suspension or revocation (except for license revocation for
394 nonpayment of license renewal fees), probationary limitations, or entry into a consent agreement which contains
395 conditions placed by a Board on the applicant’s professional conduct and practice, including the voluntary
396 surrender of the applicant’s license to practice pharmacy.
397 (2) The applicant has an impairment related to drugs, alcohol, or mental competence.
398 (3) The applicant has a criminal conviction record or a pending criminal charge related to a crime that is
399 substantially related to the practice of pharmacy. However, after a hearing or review of documentation and
400 consideration of the factors set forth in § 8735(x)(3) of Title 29, the Board by an affirmative vote of a majority of
401 the quorum, shall waive this paragraph (c)(3), if it finds that granting a waiver would not create an unreasonable
402 risk to public safety.
403 a.-d. [Repealed.]
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404 (a) An applicant who is applying for licensure as a pharmacist under this chapter shall submit evidence, verified by
405 oath and satisfactory to the Board, that the applicant meets all of the following requirements:
406 (1) Has completed the requirements for graduation from a school or college of pharmacy accredited by
407 the American Council on Pharmaceutical Education; or, if the applicant was educated outside of the United States
408 or its territories, has met the education requirements set forth in the Board’s rules and regulations.
409 (2) Has obtained practical experience as an intern in the practice of pharmacy during or after attendance
410 at a school or college of pharmacy, under such terms and conditions as set forth in the Board’s rules and
411 regulations.
412 (3) Has received a passing score on the North American Pharmacist Licensure Examination (NAPLEX)
413 as developed and approved by NABP or its successor.
414 (4) Has received a passing score on a jurisprudence examination as set forth in the Board’s rules and
415 regulations.
416 (5) Has not receive an administrative penalty regarding the practice of pharmacy, including formal
417 reprimands, license suspension or revocation (except for license revocation for nonpayment of license renewal
418 fees), probationary limitations, or entry into a consent agreement which contains conditions placed by a Board on
419 the applicant’s professional conduct and practice, including the voluntary surrender of the applicant’s license to
420 practice pharmacy.
421 (6) Does not have a current condition that impairs the applicant’s judgment or adversely affects the
422 applicant’s ability to practice safely and in a competent, ethical, and professional manner.
423 (7) The applicant has a criminal conviction record or a pending criminal charge related to a crime that is
424 substantially related to the practice of pharmacy. However, after a hearing or review of documentation and
425 consideration of the factors set forth in § 8735(x)(3) of Title 29, the Board by an affirmative vote of a majority of
426 the quorum, may waive this paragraph if it finds that granting a waiver would not create an unreasonable risk to
427 public safety.
428 (b) An applicant for licensure as an intern must meet the following requirements:
429 (1) The applicant must submit an “Application for Registration of Internship” after entering the first
430 professional year at a school or college of pharmacy accredited by the American Council on Pharmaceutical
431 Education. The application must include an “Affidavit of Class Standing” form and an “Affidavit of Preceptor”
432 form. The application and requisite forms are set forth by the Board or the Division.
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433 (2) If the applicant was educated outside of the United States or its territories, the applicant must meet the
434 education requirements set forth in the Board’s rules and regulations.
435 (3) The applicant has not received an administrative penalty regarding the practice of pharmacy,
436 including formal reprimands, license suspension or revocation (except for license revocation for nonpayment of
437 license renewal fees), probationary limitations, or entry into a consent agreement which contains conditions placed
438 by a Board on the applicant’s professional conduct and practice, including the voluntary surrender of the
439 applicant’s license to practice pharmacy.
440 (4) Does not have a current condition that impairs the applicant’s judgment or adversely affects the
441 applicant’s ability to practice safely and in a competent, ethical, and professional manner.
442 (5) The applicant has a criminal conviction record or a pending criminal charge related to a crime that is
443 substantially related to the practice of pharmacy. However, after a hearing or review of documentation and
444 consideration of the factors set forth in § 8735(x)(3) of Title 29, the Board by an affirmative vote of a majority of
445 the quorum, may waive this paragraph if it finds that granting a waiver would not create an unreasonable risk to
446 public safety.
447 (d) (c) An applicant shall submit fingerprints and other necessary information in order to obtain a report of the
448 individual’s entire criminal history record from the State Bureau of Identification and from the Federal Bureau of
449 Investigation pursuant to Federal Bureau of Investigation appropriation of Title II of Public Law 92-544 (28 U.S.C § 534).
450 If the applicant does not have a criminal history record, the applicant shall cause to be submitted a statement from each
451 agency that the agency has no record of criminal history information relating to the applicant. The State Bureau of
452 Identification shall be is the intermediary for the purpose of this subsection and the Board, or its designee, shall be is the
453 screening point for the receipt of the federal criminal history record. The applicant is responsible for the required fee, if any,
454 for obtaining the records.
455 (e) (d) If the Board finds that false information has been intentionally provided to the Board, it shall report its
456 finding to the Attorney General’s Office for further action.
457 (f) (e) If the Board refuses to accept, or rejects, an application and the applicant believes that the Board acted
458 without justification, justification or imposed higher or different standards for the applicant than for other applicants, or in
459 some other unlawful manner contributed to or caused the refusal or rejection of the application, the applicant may appeal to
460 the Superior Court.
461 § 2509. Examination.
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462 (a) The Board shall adopt the administration, grading procedures, and passing score of the North American
463 Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (MPJE) or of
464 comparable alternative national examinations.
465 (b) The Board shall determine in its rules and regulations the frequency and conditions under which a candidate
466 may retest after a failure.
467 § 2510. Reciprocity or license transfer.
468 (a) The Board shall grant a license to practice pharmacy to a reciprocal applicant who pays the appropriate fee,
469 submits a completed application on forms provided by the Board and which completed application is accepted by the
470 Board, and who otherwise qualifies pursuant to subsection (b) of this section and sends proof to the Board that:
471 (a) Upon payment of the appropriate fee and submission of an application, the Board shall grant a license to each
472 applicant who presents proof of current licensure, in good standing, in another state, the District of Columbia, or territory of
473 the United States and who, in addition:
474 (1) The reciprocal applicant’s current licensure is in good standing in another state, the District of
475 Columbia, or a territory of the United States;
476 (1) Meets the criteria for licensure in good standing as defined in § 2508(a)(5)-(7) in all states in which
477 the applicant is or was licensed.
478 (2) The reciprocal applicant Has passed the NAPLEX and MPJE or a comparable alternative national
479 examination adopted accepted by the Board for this State; and Board.
480 (3) Has received a passing score on a jurisprudence examination as set forth in the Board’s rules and
481 regulations.
482 (4) The reciprocal applicant Has passed the examination of the Foreign Pharmacy Graduate Examination
483 Committee (FPGEC) of the National Association of Boards of Pharmacy Foundation (NABP) NABP, if the
484 applicant is a graduate of a foreign school of pharmacy.
485 (5) Has submitted fingerprints and other necessary information in order to obtain a report of the
486 individual’s entire criminal history record from the State Bureau of Identification and from the Federal Bureau of
487 Investigation pursuant to Federal Bureau of Investigation appropriation of Title II of Public Law 92-544 (28 U.S.C
488 § 534). If the applicant does not have a criminal history record, the applicant shall cause to be submitted a
489 statement from each agency that the agency has no record of criminal history information relating to the applicant.
490 The State Bureau of Identification is the intermediary for the purpose of this subsection and the Board, or its
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491 designee, is the screening point for the receipt of the federal criminal history record. The applicant is responsible
492 for the required fee, if any, for obtaining the records.
493 (b) The provisions of § 2508(c), (d), (e), and (f) of this title apply to reciprocal applicants. If a disciplinary
494 proceeding or unresolved complaint is pending against a reciprocal applicant, the reciprocal applicant may not be licensed
495 in this State until the proceeding or complaint has been resolved to the satisfaction of the Board. A reciprocal applicant for
496 licensure in this State is deemed to have given consent to the release of information regarding disciplinary proceedings and
497 unresolved complaints and to have waived all objections to the admissibility of the information as evidence at any hearing
498 or other proceeding to which the reciprocal applicant may be subjected.
499 (c) (b) A reciprocal applicant is not required to obtain the practical experience pursuant to § 2508(b) required
500 under § 2508(a) of this title.
501 § 2511. Fees.
502 The amount charged by the Division for each fee imposed under this chapter must approximate and reasonably
503 reflect the cost necessary to defray the expenses of the Board as well as the proportional expenses incurred by the Division
504 in its services or activities on behalf of the Board. A separate fee may be charged for each service or activity. At the
505 beginning of each licensure biennium, the Division, or a state agency acting on its behalf, shall compute and set the fee for
506 the licensure biennium.
507 § 2512. Issuance and renewal of license; reinstatement; inactive status.
508 (a) The Board shall issue a license to each applicant who meets the requirements of this chapter and the Board’s
509 rules and regulations for licensure to practice pharmacy and who pays the required fee established under § 2511 of this
510 title.
511 (b) A license to practice pharmacy must be renewed biennially, in a manner determined by the Division, and must
512 include payment of the appropriate fee and attestation that the licensee has met the continuing education requirements
513 established by the Board.
514 (c) A licensee who has allowed that licensee’s license to lapse for more than 1 year but for less than 4 years may
515 renew such lapsed license upon completion of all of the following:
516 (1) Payment of a late fee established by the Division.
517 (2) Providing proof that the licensee has met any continuing education requirements established by the
518 Board.
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519 (3) Submission of fingerprints and other necessary information in order to obtain a report of the
520 individual’s entire criminal history record from the State Bureau of Identification and from the Federal Bureau of
521 Investigation.
522 (4) Review of NABP clearinghouse for discipline in other jurisdictions.
523 (d) A licensee who has allowed that licensee’s license to lapse for longer than 4 years may reinstate such license
524 upon completion of all of the following:
525 (1) Payment of a late fee established by the Division.
526 (2) Providing proof that the licensee has met any continuing education requirements established by the
527 Board.
528 (3) Submission of fingerprints and other necessary information in order to obtain a report of the
529 individual’s entire criminal history record from the State Bureau of Identification and from the Federal Bureau of
530 Investigation.
531 (4) Review of NABP clearinghouse for discipline in other jurisdictions.
532 (5) Proof of re-taking and passing the MPJE.
533 (e) Any licensee, upon written request, may be placed in an inactive status for up to 4 years, and the licensee may
534 reactivate the license after meeting all of the following criteria:
535 (1) Providing the Board with written notification that the licensee intends to reactivate the license.
536 (2) Satisfying all the continuing education requirements set forth in the Board’s rules and regulations.
537 (3) Paying the appropriate renewal fee.
538 (4) Submitting fingerprints and other necessary information in order to obtain a report of the individual’s
539 entire criminal history record from the State Bureau of Identification and from the Federal Bureau of Investigation.
540 (5) Review by the Division or the Board of the NABP clearinghouse for discipline in other jurisdictions.
541 (f) If a licensee who has been placed on inactive status under subsection (e) of this section fails to reactivate that
542 license within 4 years of being placed on inactive status under subsection (e) of this section, the individual must reapply for
543 licensure and re-take and pass the MPJE.
544 (b) A license to practice pharmacy must be renewed biennially, in a manner determined by the Division. License
545 renewal must include the completion and submission of a renewal form provided by the Division, payment of the
546 appropriate fee, and proof that the licensee has met the continuing education requirements established by the Board.
547 (c) The Board shall not renew any license to any applicant unless and until the applicant has offered proof that the
548 applicant has completed continuing professional education relating to:
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549 (1) The distribution, dispensing or delivery of controlled substances, as defined in this chapter; or
550 (2) The detection and recognition of symptoms, patterns of behavior, or other characteristic of impairment and
551 dependency resulting from the abusive or illegal use of controlled substances; and
552 (3) Other topics as the Board deems appropriate.
553 (d) The Board, in its rules and regulations, shall determine the period of time within which a licensee may renew
554 that licensee’s own license, notwithstanding the fact that the licensee failed to renew that licensee’s own license on or
555 before the designated renewal date; provided, however, that the period of time may not exceed 1 year beyond the
556 designated renewal date.
557 (e) A licensee, upon the licensee’s written request, may be placed on inactive status for no more than 4 years. A
558 licensee on inactive status who desires to reactivate that licensee’s own license shall complete and submit an application
559 form approved by the Board, submit the renewal fee set by the Division, and submit proof of fulfillment of the continuing
560 education requirements established by the Board.
561 (f) If a licensee is on inactive status for more than 4 years, that licensee may be relicensed, but only by following the
562 reentry process established by the Board in its rules and regulations.
563 § 2513. Temporary license.
564 The Executive Secretary may issue a temporary, 90-day license to practice pharmacy to a person who has made
565 application for a permanent license and whose application is pending. In issuing a temporary, 90-day license, the Board
566 may impose conditions as it considers appropriate, including, but not limited to, restrictions on the practice of pharmacy.
567 The Board may grant 1 90-day extension of a temporary license.
568 [REPEALED]
569 § 2514. Complaints.
570 (a) All complaints received by the Division must be investigated in accordance with § 8735 of Title 29.
571 (b) If the Board determines that a person is engaging in or has engaged in the practice of pharmacy or is using the
572 title “pharmacist” and is not licensed to practice pharmacy pursuant to § 2507 of this title this Chapter, the Board shall
573 request that the Office of the Attorney General issue a cease and desist order and take any other further appropriate action.
574 § 2515. Grounds for discipline.
575 (a) A pharmacist licensed under this chapter is subject to disciplinary sanctions set forth in § 2516 of this title if,
576 after a hearing, the Board finds that the pharmacist has done any of the following:
577 (1) Has employed Engaged in or knowingly cooperated in fraud or material deception in order to acquire
578 a license to practice pharmacy, has impersonated another person holding a license, has allowed another person to
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579 use the pharmacist’s license, or has aided or abetted a person not licensed to practice pharmacy to be represented
580 as a pharmacist; pharmacist.
581 (2) Has illegally Illegally, incompetently, or negligently practiced pharmacy; pharmacy.
582 (3) Has been convicted Was convicted of a crime that is substantially related to the practice of pharmacy;
583 a copy of the record of conviction certified by the clerk of the court entering the conviction is conclusive evidence
584 of conviction; conviction.
585 (4) Has used or abused drugs, as defined in § 2502(32) of this title, in the past 2 years; Has a current
586 condition that impairs the pharmacist’s judgment or adversely affects the pharmacist’s ability to practice
587 safely and in a competent, ethical, and professional manner.
588 (5) Has engaged Engaged in an act of consumer fraud or deception, engaged in the restrain restraint of
589 competition, or participated in price-fixing activities; activities.
590 (6) Has violated Violated a lawful provision of this chapter or any lawful regulation established
591 hereunder; hereunder.
592 (7) Has had Had that pharmacist’s own license to practice pharmacy suspended or revoked or has been
593 was subjected to other disciplinary action taken by the appropriate licensing authority in another jurisdiction;
594 provided, however, that the underlying grounds for the suspension, revocation, or other action in another
595 jurisdiction have been presented to the Board by certified record and the Board has determined that the facts found
596 by the appropriate licensing authority in the other jurisdiction constitute 1 or more of the acts listed in this
597 subsection. Every person licensed to practice pharmacy in this State is deemed to have given consent consents to
598 the release of information regarding license suspension or revocation or other disciplinary action by the Board of
599 Pharmacy or by other comparable agencies in other jurisdictions and to have waived waives all objections to the
600 admissibility of previously adjudicated evidence of the acts or offenses which underlie license suspension or
601 revocation or other disciplinary action; action.
602 (8) Has failed Failed to notify the Board that the pharmacist’s license to practice pharmacy in another
603 jurisdiction has been was subject to discipline, or has been was surrendered, suspended, or revoked; or that the
604 licensee has been convicted of a crime that is substantially related to the practice of pharmacy. A certified copy of
605 the record of disciplinary action, or of the surrender, suspension, or revocation of the license is conclusive
606 evidence thereof. A copy of the record of conviction certified by the clerk of the court entering the conviction is
607 conclusive evidence of conviction; or conviction.
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608 (9) Has a physical or mental impairment that prevents the pharmacist from engaging in the practice of
609 pharmacy with reasonable skill, competence, and safety to the public.
610 (10) Violated the Board’s Code of Ethics as adopted in the Board’s rules and regulations.
611 (b) Subject to the provisions of this chapter and subchapter IV of Chapter 101 of Title 29, the Board shall may not
612 restrict, suspend, or revoke discipline a license to practice pharmacy or limit a licensee’s right to engage in the practice of
613 pharmacy until the Board gives to the licensee proper notice and opportunity to be heard.
614 § 2516. Disciplinary sanctions.
615 (a) The Board may impose any of the following sanctions, singly or in combination, when it determines that a
616 person licensed to practice pharmacy has violated a ground for discipline set forth in § 2515 of this title:
617 (1) Issue a letter of reprimand to the licensee; reprimand.
618 (2) Censure the licensee;
619 (3) (2) Place the licensee on probationary status and require the licensee to do any of the following:
620 a. Report regularly to the Board upon the matters that are the basis of the probation; and/or
621 probation.
622 b. Limit all practice and professional activities to those areas prescribed by the Board; Board.
623 (4) (3) Suspend the license of the licensee; licensee.
624 (5) (4) Revoke Permanently revoke the license of the licensee; licensee.
625 (6) (5) Impose an administrative penalty, not to exceed $500 $10,000 for each a first-time violation. Any
626 subsequent violations may be subject to an administrative penalty, not to exceed $50,000 for each such violation.
627 (b) The Board may withdraw or reduce conditions of probation imposed pursuant to under paragraph (a)(3) (a)(2)
628 of this section, section if it finds that the deficiencies that required the conditions of probation to be imposed have been
629 remedied.
630 (c) If the Board suspends a license to practice pharmacy due to an impairment of the licensee, the Board may
631 reinstate the license if, after a hearing, the Board is satisfied that the licensee is able to practice pharmacy with reasonable
632 skill, competence, and safety to the public.
633 § 2517. Hearing procedures.
634 (a) If a complaint alleging a violation of § 2515 of this title is filed with the Board pursuant to under § 8735(h) of
635 Title 29, the Board shall set a time and place to conduct a hearing on the complaint. The Board shall give notice of the
636 hearing and shall conduct the hearing the hearing must be noticed and conducted in accordance with the Administrative
637 Procedures Act, Chapter 101 of Title 29.
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638 (b) A hearing pursuant to this section is informal, without the use of the Rules of Evidence. If the Board decides by
639 a majority vote of all members that the complaint has merit, the Board may take any action permitted under this chapter that
640 the Board considers necessary. The Board’s decision must be in writing and must include the reasons for the decision. The
641 Board shall immediately mail its decision to the licensee or personally serve the licensee with the decision.
642 (c) (b) If a licensee is in disagreement with the decision of the Board, the licensee may appeal the Board’s decision
643 to the Superior Court within 30 days of the postmarked date of the copy of the decision is mailed to that licensee, or within
644 30 days of service. Upon appeal, the Court shall hear the evidence on the record. A stay pending review may be granted by
645 the Court in accordance with § 10144 of Title 29.
646 § 2518. Reinstatement of a suspended license; removal from probationary status.
647 (a) As a condition of reinstatement of a suspended license or the issuance of another license after revocation, the
648 Board may impose any condition or conditions that are authorized under this chapter. Before reinstating a suspended
649 license or removing a licensee from probationary status, the Board shall, without a hearing, make a determination as to
650 whether the licensee has taken the required corrective actions and has satisfied all of the conditions imposed pursuant to the
651 license suspension and/or the probation period. A licensee who disagrees with a determination made by the Board under
652 this subsection may request a hearing before the Board.
653 (b) A licensee seeking reinstatement or removal from probationary status must pay the appropriate fees and submit
654 the evidence required by the Board to show that all the conditions imposed pursuant to the license suspension and/or the
655 probation period have been met. Proof that the licensee has met that licensee’s continuing education requirements may also
656 be required.
657 § 2519. Temporary suspension pending hearing.
658 In the event of a formal or informal complaint concerning the activity of a licensee that presents a clear and
659 immediate danger to the public health, safety or welfare, the Board may temporarily suspend the person’s license, pending a
660 hearing, upon the written order of the Secretary of State or the Secretary’s designee, with the concurrence of the Board
661 chair or the Board chair’s designee. An order temporarily suspending a license may not be issued unless the person or the
662 person’s attorney received at least 24 hours’ written or oral notice before the temporary suspension so that the person or the
663 person’s attorney may file a written response to the proposed suspension. The decision as to whether to issue the temporary
664 order of suspension will be decided on the written submissions. An order of temporary suspension pending a hearing may
665 remain in effect for no longer than 60 days from the date of the issuance of the order unless the temporarily suspended
666 person requests a continuance of the hearing date. If the temporarily suspended person requests a continuance, the order of
667 temporary suspension remains in effect until the hearing is convened and a decision is rendered by the Board. A person
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668 whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Board shall
669 schedule the hearing on an expedited basis, provided that the Board receives the request within 5 calendar days from the
670 date on which the person received notification of the decision to temporarily suspend the person’s license.
671 § 2520. Counseling of pharmacists.
672 (a) If the Executive Secretary and the President of the Board jointly find after an investigation that a pharmacist
673 has violated a provision of this chapter or a regulation enacted pursuant to this chapter, but that the violation can be
674 reasonably resolved without a formal disciplinary sanction under § 2516 of this title, the Executive Secretary and the
675 president, or his or her designee, may counsel the pharmacist regarding the violation. The Executive Secretary shall notify
676 the pharmacist in writing of the finding and of the decision not to proceed with formal disciplinary sanctioning. The
677 notification must explain the finding and request the presence of the pharmacist at a counseling session. During the
678 counseling session, the Executive Secretary and the president, or his or her designee, shall discuss with the pharmacist the
679 violation, and establish a plan of correction, if necessary.
680 (b) Counseling pursuant to subsection (a) of this section is voluntary. However, if the pharmacist fails to attend the
681 counseling session or fails to comply with the necessary plan of correction specified by the Executive Secretary and the
682 president, or his or her designee, the violation must be handled in the same manner as a violation of § 2515 of this title is
683 handled.
684 (c) The counseling of a pharmacist under this section is not considered disciplinary action if the pharmacist attends
685 the counseling session and complies with any necessary plan of correction required by the Executive Secretary and the
686 president, or his or her designee. Counseling pursuant to this section may not be used in considering disciplinary sanctions
687 in a future hearing unrelated to the incident for which the pharmacist was counseled unless the future incident involves the
688 same or similar allegations as those for which the pharmacist was counseled.
689 § 2521. Impaired pharmacist.
690 (a) An “impaired pharmacist” is a pharmacist whose use or abuse of drugs or alcohol affects that pharmacist’s
691 ability to practice pharmacy. An impaired pharmacist may be eligible to enter an approved treatment program pursuant to
692 an agreement with the Executive Secretary and the Board president.
693 (b) Disciplinary action will not be taken against a pharmacist who enters into and successfully completes an
694 approved treatment program pursuant to subsection (a) of this section as long as a complaint has not been filed against the
695 pharmacist and as long as the pharmacist has not been convicted of, or has not pleaded guilty or nolo contendere to a felony
696 or a drug offense. Records related to a treatment program under this section are not public records, and may be used in a
697 subsequent related disciplinary matter before the Board only if the pharmacist was, or could have been, disciplined.
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698 (c) A pharmacist who does not qualify under subsection (b) of this section may, nevertheless, enter into an
699 agreement with the Executive Secretary and the Board President to participate in an approved treatment program. Action on
700 a disciplinary complaint may be deferred and ultimately dismissed if the pharmacist successfully completes the treatment
701 program.
702 (d) An agreement pursuant to this section that permits an impaired pharmacist to enter into an approved treatment]
703 program must contain at least the following provisions:
704 (1) The pharmacist must agree not to engage in the practice of pharmacy for the duration of the treatment
705 program.
706 (2) The pharmacist must sign a release so that records of treatment and progress are released to the
707 Executive Secretary and the Board president.
708 (3) If the pharmacist does not make satisfactory progress in the program, the agreement is void and an
709 investigation and disciplinary proceedings may be pursued.
710 (4) The pharmacist must agree to submit to random drug and alcohol screening at a specified laboratory
711 or health care facility.
712 (5) The pharmacist must agree to be personally responsible for all cost related to the program.
713 (e) A pharmacist who successfully completes an approved treatment program may return to the practice of
714 pharmacy if the Executive Secretary and the Board President determine that the pharmacist’s return to practice will not
715 endanger the public health, safety, or welfare. The Executive Secretary and the President may require the pharmacist to
716 agree to specific conditions of practice to protect the public.
717 Subchapter III. Miscellaneous provisions Prescription labeling; exemptions
718 § 2522. Prescription labeling.
719 (a) A practitioner prescribing a drug to be prepared and dispensed by a pharmacist in this State for the use of a
720 patient or any third person must, as part of the prescription, include directions describing the exact method by which the
721 drug must be taken or administered. A prescription without specific directions, or a prescription bearing the notation “as
722 directed” without specific directions, may not be prepared or dispensed.
723 (b) A pharmacist shall affix must ensure that a label is affixed to every container in which a drug is dispensed a
724 dispensed. The label containing must contain the following information: information required by the Board’s rules and
725 regulations.
726 (1) Prescription number;
727 (2) The date the prescription is dispensed;
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728 (3) Patient’s full name;
729 (4) Brand or established name and strength of the drug to the extent that it can be measured;
730 (5) Practitioner’s directions as found on the prescription;
731 (6) Practitioner’s name;
732 (7) Name and address of the dispensing pharmacy or practitioner.
733 (c) Practitioners who, for good reason, do not wish to reveal the name or strength of the drug prescribed to the
734 patient shall so inform the pharmacist by a notation on the face of the prescription. However, practitioners who sell drugs
735 directly to patients shall label all such drugs in accordance with this section with the exception of a prescription number.
736 Practitioners who sell or dispense drugs directly to patients shall must label all drugs or provide a document including that
737 includes all of the following information:
738 (1) The patient’s full name; name and address.
739 (2) The date the drugs were dispensed to the patient; patient.
740 (3) The practitioner’s name; name, office phone number, and address.
741 (4) The practitioner’s DEA number in the case of a controlled substance.
742 (5) Name, strength, dosage form, and quantity (or Stop Date) of drug and route of administration if other
743 than oral form of drug is prescribed.
744 (6) Renewals authorized.
745 (4) (7) The practitioner’s directions.
746 (d) No pharmacist shall may fail to dispense a prescription because it is not clearly written and/or or lacks
747 information required by this title without first making a reasonable effort to contact the practitioner who issued the
748 prescription to gather the clear and complete information.
749 § 2523. Exemptions.
750 Nothing in this chapter may be construed to prevent any of the following:
751 (1) A student or graduate of an accredited school of pharmacy from receiving practical training pursuant
752 to an internship or other approved program under the supervision of a pharmacist in this State; State.
753 (2) A pharmacy intern, or a pharmacy student participating in an approved College of Pharmacy
754 coordinated practical experience program under the direct supervision of a licensed pharmacist, from performing
755 the functions permitted under the rules and regulations of the Board and not inconsistent with this chapter.
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756 (2) (3) A pharmacy technician or certified pharmacy technician from performing under the direct
757 supervision of a pharmacist the delegated functions permitted under the rules and regulations of the Board and not
758 inconsistent with this chapter; chapter.
759 (3) (4) A practitioner licensed under the laws of this State to practice within the scope of that
760 practitioner’s license; license.
761 (4) (5) The selling at retail of over-the-counter products; products.
762 (5) (6) A business not licensed as a pharmacy to sell gases that are used for medicinal purposes and which
763 require a prescription, provided that:
764 a. The business is registered with the Board; Board.
765 b. The sale is authorized by a written written, electronic, or fax order or by a verbal order
766 reduced to writing from a practitioner; licensed practitioner.
767 c. The record of the written written, electronic, or fax order, or order or of the verbal order
768 reduced to writing is maintained on the premises of the business for at least 2 years; and 3 years.
769 d. The gas product is stored and dispensed according to requirements established by the Board.
770 (6) (7) The sale of noncontrolled prescription drugs designated for veterinary use by a business not
771 licensed as a pharmacy, provided that the business is registered with the Board and the sale is authorized by a
772 written written, electronic, or fax order or by a verbal order reduced to writing from a licensed veterinarian.
773 (7) A pharmacist in this State from dispensing a valid noncontrolled prescription drug pursuant to a
774 prescription received via electronic transmission from a practitioner’s office to the prescription department of the
775 dispensing pharmacy.
776 (8) Pharmacist selection of appropriate dosage forms, concentrations, equivalent strengths or routes of
777 administration of medications.
778 (9) a. A practitioner from dispensing the unused portion of practitioner-dispensed medication to the
779 patient upon discharge or the conclusion of the visit if the practitioner-dispensed medication is labeled consistent
780 with the requirements under § 2522 of this title and required for continuing treatment. If the practitioner-dispensed
781 medication is used in an operating room or emergency department, the practitioner must counsel the patient on the
782 proper use and administration of the drug.
783 b. A practitioner who fails to comply with paragraph (9)a. of this section is subject to disciplinary
784 sanction under this title.
785 § 2524. Miscellaneous fees.
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786 The Division shall set fees to defray registration costs, costs for maintaining registries required under this
787 chapter, and the costs of replacing lost or destroyed licenses and permits.
788 § 2525. Testing, screening, and treatment of health conditions.
789 (a) Pursuant to a statewide written protocol approved by the Division of Public Health, a pharmacist may
790 order, test, screen, and treat health conditions that include all of the following:
791 (1) Influenza.
792 (2) Group A streptococcus pharyngitis.
793 (3) SARS-COV-2 or other respiratory illness, condition, or disease.
794 (4) Lice.
795 (5) Skin conditions, including ringworm and athlete’s foot.
796 (6) Other emerging and existing public health threats identified by the Division of Public Health if
797 permitted by an order, rule, or regulation.
798 (b) A pharmacist who orders, tests, screens, or treats health conditions under this section may use any test
799 that may guide clinical decision making that is waived under the federal Clinical Laboratory Improvement Amendments of
800 1988 [42 U.S.C. § 263a], or the federal rules adopted thereunder, or any established screening procedure that is established
801 via a statewide protocol.
802 (c) A pharmacist may delegate the administrative and technical tasks of performing a test waived by the
803 federal Clinical Laboratory Improvement Amendments of 1988 to an intern or pharmacy technician acting under the
804 supervision of the pharmacist.
805 (d) Prohibit the denial of reimbursement under health benefit plans for services and procedures performed by a
806 pharmacist that are within the scope of the pharmacist’s license and would be covered if the services or procedures were
807 performed by a physician, an advanced practice nurse, or physicians assistant.
808 § 2525A. Human immunodeficiency virus (HIV) pre-exposure prophylaxis and HIV post-exposure prophylaxis.
809 (a) Pursuant to a statewide written protocol approved by the Division of Public Health, a pharmacist may
810 initiate, dispense, or administer medications for HIV pre-exposure prophylaxes and for HIV post-exposure prophylaxis,
811 which includes administering laboratory tests, conducting assessments and consultations, and providing referrals,
812 (b) When initiating therapy for and administering or dispensing HIV pre-exposure prophylaxis or HIV post-
813 exposure prophylaxis under a statewide protocol, a pharmacist must complete a training program approved by the
814 Board within 1 year prior to first-time initiating therapy and administering or dispensing HIV pre-exposure prophylaxis or
815 HIV post-exposure prophylaxis. The training program must include information about all of the following:
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816 (1) Financial assistance programs for HIV pre-exposure prophylaxis and HIV post-exposure prophylaxis.
817 (2) Relevant federal guidelines regarding HIV pre-exposure prophylaxis or HIV post-exposure
818 prophylaxis.
819 (c) When initiating therapy for and administering or dispensing HIV pre-exposure prophylaxis or HIV post-
820 exposure prophylaxis to a new patient, a pharmacist may not allow the patient to waive consultation for HIV pre-exposure
821 prophylaxis or HIV post-exposure prophylaxis.
822 (d) HIV pre-exposure prophylaxis. — (1) Under a statewide protocol, a pharmacist may dispense between a 30-
823 day and 60-day supply of HIV pre-exposure prophylaxis if the all of the following apply:
824 a. The patient is HIV-negative as documented by a negative HIV test result obtained within the previous
825 7 days from a test approved by the U.S. Food and Drug Administration.
826 b. The patient does not report any of the following:
827 1. Any signs or symptoms of acute HIV infection on a self-reported checklist of acute HIV infection
828 signs and symptoms.
829 2. Usage of any contraindicated medication.
830 c. The pharmacist provides counseling to the patient on the ongoing use of HIV pre-exposure prophylaxis,
831 which must include education about all of the following:
832 1. Side effects.
833 2. Safety during pregnancy and breastfeeding.
834 3. Adherence to recommended dosing.
835 4. The importance of timely testing and treatment for HIV, renal function, hepatitis B, hepatitis C,
836 sexually-transmitted infections, and pregnancy for individuals of childbearing capacity.
837 5. The requirement for subsequent prescriptions for HIV pre-exposure prophylaxis issued by a primary-
838 care provider.
839 d. To the extent possible, the pharmacist documents the services provided by the pharmacist in the patient record
840 system shared with the primary-care provider.
841 (2) If the test results from a test under paragraph (d)(1)a. of this section are not sent directly to the
842 pharmacist, the pharmacist must verify the test results.
843 (3) If the patient tests positive for HIV infection from a test under paragraph (d)(1)a. of this section, the
844 pharmacist shall do the following and document in the patient’s record which of the following was done:
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845 a. If the patient has a primary-care provider, send the result of the test to the patient’s primary-care
846 provider after obtaining written permission from the patient to do so.
847 b. If the patient does not give written permission under paragraph (d)(3)a. of this section or if the patient
848 does not have a primary-care provider, provide a list of providers and clinics in the region that provide care for
849 patients with HIV.
850 (4) If the patient does not provide evidence of a negative HIV test under paragraph (d)(1)a. of this
851 section, the pharmacist shall initiate and administer an HIV test and interpret the test results prior to initiating any
852 treatment under this subsection.
853 (e) HIV post-exposure prophylaxis. — (1) Under a statewide protocol, a pharmacist may dispense a course of HIV
854 post-exposure prophylaxis if the pharmacist does all of the following:
855 a. Screens the patient and determines that the exposure to HIV occurred within the previous 72 hours.
856 b. Provides HIV testing or determines that the patient is 1 of the following:
857 1. Willing to undergo HIV testing consistent with federal guidelines.
858 2. Unwilling to undergo HIV testing but otherwise eligible for HIV post-exposure prophylaxis.
859 c. Provides counseling to the patient on the ongoing use of HIV post-exposure prophylaxis, which must include
860 education about all of the following:
861 1. Side effects.
862 2. Safety during pregnancy and breastfeeding.
863 3. Adherence to recommended dosing.
864 4. The importance of timely testing and treatment for HIV, renal function, hepatitis B, hepatitis C,
865 sexually-transmitted infections, and pregnancy for individuals of childbearing capacity.
866 5. The availability of HIV pre-exposure prophylaxis for a person who is at a substantial risk of acquiring
867 HIV.
868 d. To the extent possible, documents the services provided by the pharmacist in the patient record system shared
869 with the primary-care provider.
870 Subchapter IV. Pharmacies
871 § 2526. Permit required for each pharmacy.
872 (a) A person may not operate a pharmacy within the State without first having obtained a permit to operate a
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873 pharmacy from the Board. A person who desires to operate more than 1 pharmacy must make a separate permit application
874 for each pharmacy. However, separate permits are not required for sites designated as pharmacies within the same
875 institution at 1 general location, provided that each site is approved by the Board.
876 (b) The Board shall issue a separate permit for each qualifying pharmacy. A permit to operate a pharmacy granted
877 by the Board may not be assigned or otherwise transferred to another person except upon such conditions as the Board
878 specifically designates, and then only pursuant to the written consent of the Board or its designee. A permit must be
879 available on site for inspection by authorized persons.
880 § 2527. Application fees for permits.
881 The application for a permit to operate a pharmacy must be made on a form furnished by the Board and must be
882 accompanied by the application fee and/or permit fee established pursuant to § 2511 of this title.
883 § 2528. Requirements for and issuance of permit license.
884 (a) In determining if a permit to operate a pharmacy should be issued, the Board shall consider, but is not limited
885 to considering, the probability that: Upon submission of an application, payment of the appropriate fee, and fulfillment of
886 all standards set by the Board by rules and regulations, the Board shall issue a license when the applicant provides
887 evidence, verified by oath, that the pharmacy meets all of the following requirements:
888 (1) The pharmacy will be operated in full compliance with the law and with the rules and regulations of
889 the Board; Board.
890 (2) The pharmacy will be managed by a pharmacist-in-charge who is licensed to practice pharmacy in the
891 State State. and who will serve as a pharmacist-in-charge in only that pharmacy; Each pharmacy may only have 1
892 pharmacist-in-charge, and that pharmacist-in-charge may only be a pharmacist-in-charge of 1 pharmacy.
893 (3) The location and appointments of the pharmacy are such that it can be operated without endangering
894 public health, safety, or welfare. In determining a danger to public health, safety, or welfare, the Board shall
895 consider, but is not limited to considering, the following factors: meet the requirements set forth in the Board’s
896 rules and regulations.
897 a. Whether an applicant, permit holder, principal, or a person having ownership interest in the
898 pharmacy has a conviction for deceptive business practices or for a violation of drug laws under federal
899 law or any state’s law;
900 b. Whether an applicant, permit holder, principal, or a person having controlling ownership interest
901 in the pharmacy has been or is the subject of an action by a regulatory agency for a violation of the
902 agency’s statutes or regulations;
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903 (4) The pharmacist-in-charge, whose name is on the application, will must comply with pharmacy, controlled
904 substance, and other applicable statutes and regulations; rules and regulations.
905 (5) The pharmacy will must provide conspicuous notice to consumers that the Board of Pharmacy is the contact
906 agency for reporting unresolved medication errors.
907 (b) (6) A permit to operate a pharmacy may not be issued or renewed unless the pharmacy is The pharmacy will be
908 equipped with proper reference materials and professional and technical equipment as provided in the Board’s rules and
909 regulations.
910 (7) The pharmacy will be inspected and approved by an agent of the Board prior to opening.
911 (8) The pharmacy has not obtained a license by misrepresentation or fraud.
912 (9) The pharmacy has not been disciplined by a regulatory agency.
913 (c) The Executive Secretary may issue a temporary, 60-day permit to operate a pharmacy to an otherwise qualified
914 pharmacy while the application for a permanent permit is pending. The Board may grant 1 60-day extension of a temporary
915 permit.
916 (b) As set forth in the Board’s rules and regulations, the applicant must designate the specific type of pharmacy
917 license requested.
918 § 2529. Renewal of permit license; closing of pharmacy.
919 (a) A permit license to operate a pharmacy must be renewed biennially in a manner determined by the Division,
920 including the payment of the renewal fee established pursuant to § 2511 of this title.
921 (b) The Board, in its rules and regulations, shall determine the period within which a permit holder may renew the
922 permit to operate a pharmacy, notwithstanding the fact that the permit holder failed to renew on or before the designated
923 renewal date; provided, however, that the period of time may not exceed 1 year beyond the designated renewal date.
924 (c) A permit As set forth in the Board’s rules and regulations, a license to operate a pharmacy terminates
925 automatically upon a transfer of the controlling interest in the pharmacy, upon a change in ownership, the termination of the
926 legal existence of the pharmacy, or upon the discontinuance of business or professional practice.
927 (d) The temporary or permanent closing of a pharmacy must be in compliance with the rules and regulations of the
928 Board. If the closing is to be permanent, the Board must be notified 14 days prior to the closing. If the closing is to be for
929 more than 7 consecutive business days, the Board must be notified 5 days prior to the temporary closing.
930 § 2530. Revocation or suspension of permit Grounds for discipline of a pharmacy license.
931 (a) The Board may suspend or revoke a permit to operate a pharmacy when examination or inspection of the
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932 pharmacy discloses that the pharmacy is not being operated according to law or is being operated in a manner which
933 endangers public health, safety, or welfare.
934 (a) A license is subject to the disciplinary actions established in § 2531A if, after a hearing, the Board finds that
935 the licensee has done one or more of the following acts:
936 (1) The pharmacy is not being operated according to the Board’s laws or rules and regulations.
937 (b) (2) The Board may suspend or revoke a permit to operate a pharmacy if the The pharmacy’s prescription
938 department is closed for more than 14 consecutive days, unless the closing of the prescription department was due
939 to a cause which the Board finds reasonable.
940 (3) The pharmacy has been disciplined by a regulatory agency.
941 (4) The pharmacy has obtained a license by misrepresentation or fraud.
942 (5) The pharmacy has refused access to the pharmacy or pharmacy records to an agent of the Board who
943 seeks access for the purpose of conducting an inspection or investigation.
944 (c) In determining if a pharmacy is being operated in a manner which endangers the public health, safety, or
945 welfare pursuant to subsection (a) of this section, the Board shall consider, but is not limited to considering, the following
946 factors:
947 (1) Compliance by the permit holder with the law and with the rules and regulations of the Board;
948 (2) A conviction of the permit holder, a principal, or a person having controlling ownership interest in the
949 pharmacy for a violation of federal law or of any state’s law other than a violation of a minor traffic offense;
950 (3) An action by a regulatory agency against the permit holder for a violation of the agency’s statutes or
951 regulations.
952 § 2531. Hearings on actions involving permits licenses.
953 (a) If the Board intends not to issue a permit license or intends to suspend or revoke discipline a permit license, the
954 Board shall give written notice to the applicant or permit holder licensee of the intended action and the reasons therefor.
955 The applicant or permit holder licensee has at least 10 days from the date of notice to request a hearing. Notice of the
956 hearing must be given and the hearing must be conducted in accordance with the Administrative Procedures Act, Chapter
957 101 of Title 29.
958 (b) A hearing pursuant to subsection (a) of this section is informal, without the use of the Rules of Evidence. The
959 Board’s decision must be in writing and must include the reasons for the decision. The Board’s decision must be mailed
960 immediately to or personally served upon the applicant or permit holder.
961 (c) (b) If an applicant or permit holder licensee is in disagreement with the decision of the Board, the applicant or
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962 permit holder licensee may appeal the Board’s decision to the Superior Court within 30 days of the postmarked date of
963 mailing the copy of a mailed decision or within 30 days of the date of service of the decision. Upon appeal, the Court shall
964 hear the evidence on the record. A stay pending review may be granted by the Court in accordance with § 10144 of Title
965 29.
966 § 2531A. Disciplinary sanctions.
967 (a) The Board may impose any of the following sanctions, individually or in combination, when it finds that a
968 pharmacy has violated any condition or committed any violation set forth in § 2530 of this title:
969 (1) Issue a letter of reprimand.
970 (2) Place a pharmacy on probationary status and require the pharmacy to:
971 a. Report regularly to the Board upon the matters which are the basis of the probation.
972 b. Limit all practice and professional activities as prescribed by the Board.
973 (3) Suspend any pharmacy’s license.
974 (4) Permanently revoke any pharmacy’s license.
975 (5) Impose a monetary penalty not to exceed $250,000 for each violation and not more than $250,000 for
976 each day of a continuing violation.
977 § 2532. Pharmacy records.
978 (a) A suitable book or file in which the original The pharmacy must maintain a record of every prescription
979 compounded or dispensed dispensed or compounded at the pharmacy must be preserved for a period of not less than 3
980 years. The book or file of original record of prescriptions must at all times be open to available for inspection by authorized
981 agents of the Board.
982 (b) Upon request by a person for such person’s pharmacy records, a pharmacy shall provide such records, in hard
983 copy paper form (unless such person agrees to another form), as soon as is reasonably possible, but by no later than 15
984 business days after such person has made the request to the pharmacy, unless an emergency or a medical condition dictates
985 that such records should be produced immediately. Nothing herein shall may be construed as limiting or lessening the
986 pharmacy’s obligations to maintain confidentiality of such records and the pharmacy shall must follow such pharmacy’s
987 standard procedures to ensure maintenance of confidentiality of such records.
988 § 2533. Prescription department.
989 The prescription department must meet the requirements of the Board’s rules and regulations.
990 (a) A pharmacy must contain a secure room or area with a door that can be locked when the pharmacy is without
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991 the attendance and supervision of a pharmacist. The secure room or area, known as the prescription department, must
992 contain the entire stock of prescription drugs, chemicals, and preparations used in compounding and preparing
993 prescriptions.
994
995 (b) Only a pharmacist is authorized to unlock and lock the prescription department of a pharmacy.
996 (c) A sign giving the name of the pharmacist-on-duty must at all times be posted in the vicinity of the prescription
997 department of a pharmacy.
998 (d) During the absence of a pharmacist, the prescription department of a pharmacy must be locked until the
999 pharmacist returns to duty. However, the merchandising section of the pharmacy may remain open.
1000 (e) A prescription department must have at least 250 square feet of floor space. The counter inside the prescription
1001 department must be at least 18 inches wide and must have 4 linear feet for each pharmacist working concurrently on
1002 dispensing and compounding prescriptions. The counter must be kept clear and free of all merchandise and other materials
1003 not currently in use in dispensing and compounding prescriptions. The aisle behind the counter must be at least 30 inches
1004 wide and must be kept free of obstruction at all times. A prescription department which existed on February 11, 1992, is
1005 exempt from the requirements of this subsection unless the department is remodeled or relocated.
1006 § 2534. Inspections.
1007 (a) An agent of the Board may enter and inspect inspect, during business hours hours, any pharmacy or other place
1008 in this State where drugs are manufactured, packed, packaged, stocked, distributed, dispensed, or offered for sale.
1009 (b) An agent of the Board acting pursuant to subsection (a) of this section may do any of the following:
1010
1011 (1) may inspect Inspect and copy records required by this chapter to be kept; kept.
1012 (2) may inspect Inspect within reasonable limits and in a reasonable manner the premises and all pertinent
1013 equipment, finished and unfinished materials, containers, and labeling found therein; therein.
1014 (3) may inspect Inspect other things therein, including records, files, papers, processes, controls, and facilities
1015 relating to a violation of this chapter; chapter.
1016 (4) and may make Make an inventory of the stock of drugs therein and obtain samples of drugs and other
1017 substances.
1018 (c) All information gathered under this section is to be kept confidential in accordance with all federal and state
1019 laws governing privacy.
§ 2535. Nonresident pharmacies.
(a) A pharmacy located outside the State in another state, the District of Columbia, or a territory of the United
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1020 States which delivers, dispenses, or distributes in any manner by any method a prescription drug to a patient an ultimate
1021 user in the State is a nonresident pharmacy and must obtain a permit to conduct business in this State must obtain a
1022 nonresident pharmacy license from the Board. A nonresident pharmacy may not deliver in any manner a prescription drug
1023 to a patient an ultimate user in this State unless it has a permit license to do so issued by the Board.
1024
1025 (b) If a nonresident pharmacy which has a permit license issued pursuant to this section delivers in any manner a
1026 prescription drug and the prescription drug is not personally hand delivered to the patient ultimate user, a written notice
1027 must be placed in theshipping container to alert the patient that:
1028
1029 (1) Under certain circumstances a prescription drug’s effectiveness may be affected by exposure to
1030 extremes of heat, cold, or humidity; and humidity.
1031
1032 (2) A local or a toll-free telephone service is available, staffed by a registered pharmacist, to answer
1033 questions about the prescription drug.
1034 (c) Upon submission of an application, payment of the appropriate fee, and fulfillment of all standards set forth in
1035 the Board’s rules and regulations, the Board shall issue a license when the applicant provides evidence, verified by oath,
1036 that the pharmacy meets all of the following requirements:
1037
1038 (1) Holds a license in good standing an all states or jurisdictions where the applicant is or was licensed.
1039 (2) Has not obtained a license by misrepresentation or fraud.
1040 (3) Has not been disciplined by a regulatory agency.
1041 (4) Submits the most recent inspection report, that is approved by the Board, and satisfies all of the
1042 following requirements:
1043
1044 a. The inspection occurred when the pharmacy was in operation.
1045 b. The inspection addresses all aspects of the pharmacy’s business that will be utilized in this
1046 State.
1047 c. The inspection was performed by or on behalf of the home state licensing authority, if
1048 available.
1049 d. The report is the most recent report available that satisfies the requirements of this paragraph
(4).
e. If the home state licensing authority has not conducted an inspection satisfying the
requirements of this paragraph (4), the pharmacy must submit an inspection report from NABP’s verified
pharmacy program or from another qualified entity as determined by the Board.
(5) Submits plans for the pharmacy department as set forth in the Board’s rules and regulations.
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1050 § 2536. Nonresident pharmacies: service of process; registered agent.
1051 (a) A nonresident pharmacy must designate a registered agent in Delaware for service of process.
1052 (b) A nonresident pharmacy that does not designate a registered agent is deemed to have appointed appoints the
1053 Secretary of State to be its agent upon whom may be served all legal process in any action or proceeding against the
1054 nonresident pharmacy relating to the delivery in any manner of prescription drugs into this State.
1055 (c) In any action or proceeding against a nonresident pharmacy, a copy of service of process must be mailed to the
1056 nonresident pharmacy by the complaining party by certified mail, return receipt requested, at the address of the nonresident
1057 pharmacy, as designated on the nonresident pharmacy’s permit application to conduct business in this State.
1058 (d) A nonresident pharmacy which does not obtain a permit in this State pursuant to this chapter is deemed to have
1059 consented consents to service of process on the Secretary of State as sufficient service.
1060 § 2537. Conditions of nonresident pharmacy’s permit to conduct business in this State Grounds for discipline of a
1061 nonresident pharmacy.
1062 (a) A nonresident pharmacy shall:
1063
1064 (1) Provide the location, names, and titles of all principal corporate officers and of all pharmacists who
1065 dispense prescription drugs in this State. This information must be provided to the Board upon application for a
1066 nonresident pharmacy’s permit to conduct business in this State and within 30 days after a change of office
1067 location or after the addition or removal of a principal corporate officer or a pharmacist;
1068
1069 (2) Certify that it complies with all lawful directions and requests for information from regulatory or
1070 licensing agencies of the state in which it is licensed and that it will comply with all such requests made by the
1071 Board pursuant to this chapter. The nonresident pharmacy shall maintain at all times a valid license, permit, or
1072 registration to operate the pharmacy, which complies with the laws of the state in which it is physically located.
1073 The nonresident pharmacy shall maintain patient profiles in compliance with Board regulations, shall comply with
1074 the provisions of § 2549 of this title, and shall provide pertinent patient information. Prior to being issued a
1075 permit, the nonresident pharmacy must provide the Board with a copy of its most recent inspection report and,
1076 thereafter, must provide the Board with inspection reports within 60 days after receipt from the regulatory
1077 licensing agency of the state in which the nonresident pharmacy is physically located;
1078
1079 (3) Certify that it maintains its records of prescription drugs dispensed to Delaware patients in a way that
the records are readily retrievable from the records of drugs dispensed to other patients;
(4) Provide a local or a toll-free telephone service, staffed by a registered pharmacist, during its regular
hours of operation, but not less than 6 days per week for a minimum of 40 hours per week, to facilitate
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1080 communication between patients in this State and pharmacists at the nonresident pharmacy who have access to
1081 patient records. The toll-free telephone number must appear on the label affixed to each container of prescription
1082 drugs dispensed to patients in this State;
1083
1084 (5) Pay the permit application or renewal fee for a nonresident pharmacy as set by the Board pursuant to §
1085 2511 of this title.
1086 (a) A nonresident pharmacy is subject to disciplinary actions established in § 2538 of this title if, after a hearing,
1087 the Board finds that the nonresident pharmacy has done one or more of the following acts:
1088
1089 (1) Obtained a license by misrepresentation or fraud.
1090 (2) Failed to operate according to the Board’s statutes, laws, and rules and regulations.
1091 (3) Failed to maintain at all times a valid license to operate the pharmacy, which complies with the
1092 statutes, laws, and rules and regulations of the state in which it is physically located.
1093 (4) Failed to maintain patient profiles in compliance with Board rules and regulations.
1094 (5) Failed to provide the Board with inspection reports within 60 days after receipt from the regulatory
1095 licensing agency of the state in which the nonresident pharmacy is physically located.
1096 (6) Failed to maintain its records of prescription drugs dispensed to Delaware patients in a way that the
1097 records are readily retrievable, but no more than 15 days, from the records of drugs dispensed to other patients.
1098 (7) Been disciplined by a regulatory agency.
1099 (b) The Board shall report any disciplinary action it takes against a nonresident pharmacy to the Board board in the
1100 state where the pharmacy is physically located.
1101 § 2538. Nonresident pharmacies: violations; penalties Disciplinary sanctions for nonresident pharmacies.
1102 (a) The Board may suspend or revoke the permit to conduct business in this State of a nonresident pharmacy
1103 permit holder who violates federal law or any state’s law, any of the conditions of the permit, or any of the rules or
1104 regulations adopted by the Board. The Board may impose an administrative penalty of not more than $50 for each day a
1105 violation occurs and/or continues.
1106 (a) The Board may impose any of the following sanctions, individually or in combination, when it finds that a
1107 nonresident pharmacy has violated any condition or committed any violation set forth in § 2537 of this title:
1108 (1) Issue a letter of reprimand.
1109 (2) Place a nonresident pharmacy on probationary status, and require the nonresident pharmacy to:
a. Report regularly to the Board upon the matters which are the basis of the probation.
b. Limit all practice and professional activities as prescribed by the Board.
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1110 (3) Suspend any nonresident pharmacy’s license.
1111 (4) Permanently revoke any nonresident pharmacy’s license.
1112 (5) Impose a monetary penalty not to exceed $250,000 for each violation and not more than $250,000 for
1113 each day of a continuing violation.
1114 (b) A person who operates a pharmacy located outside the State and delivers in any manner a prescription drug
1115 into the State without having obtained a permit license to conduct business in this State pursuant to this chapter commits the
1116 offense of operating a nonresident pharmacy without a permit license and may be fined not more than $50 $10,000 for each
1117 day that the offense occurs and/or or continues.
1118 Subchapter V. Pharmaceutical Establishments Other Than Pharmacies
1119 § 2540. Requirements for pharmaceutical activities not carried on in a pharmacy.
1120 (a) Drugs, toilet preparations, dentifrices, and cosmetics Drugs may not be manufactured, packed, packaged, or
1121 distributed within this State unless done so under the personal and immediate supervision of a person approved by the
1122 Board after investigation and determination by the Board that the person is qualified by scientific or technical training,
1123 education, or experience to perform the duties of supervision that are necessary to protect public health, safety, and welfare.
1124 as set forth in the Board’s rules and regulations.
1125 (b) A person may not operate a pharmaceutical establishment to manufacture, pack, package, or distribute on a
1126 wholesale basis to persons other than the ultimate consumer any drugs, toilet preparations, dentifrices, or cosmetics without
1127 first obtaining from the Board a permit license to operate a pharmaceutical establishment. This subchapter also applies to
1128 the activities of a reverse distributor who acts as an agent for a person permitted to operate a pharmaceutical establishment
1129 by receiving, inventorying, and managing the disposition of outdated or otherwise nonsalable drugs. A permit license
1130 issued pursuant to this subchapter must be available for inspection by authorized persons.
1131 (c) A person who has a permit to operate a pharmaceutical establishment is subject to Board rules and regulations
1132 with respect to the storage and handling of drugs and to the establishment and maintenance of drug distribution records, and
1133 must comply with federal, state, and local law.
1134 (d) A permit As set forth in the Board’s rules and regulations, a license to operate a pharmaceutical establishment
1135 issued pursuant to this subchapter terminates automatically upon a transfer of the controlling interest in the pharmaceutical
1136 establishment, upon a change in ownership, the termination of the pharmaceutical establishment’s legal existence, or upon
1137 the discontinuance of business or professional practice.
1138 (e) Nothing in this subchapter may be construed to apply to pharmacies.
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1139 § 2540A. Requirements for issuance of license for manufacturers, wholesale distributors, outsourcing facilities,
1140 and medical gas distributors.
1141
1142 (a) All applicants under this subchapter must meet all of the following requirements:
1143 (1) The establishment must operate under the personal and immediate supervision of a person who meets
1144
1145 state and federal requirements.
1146 (2) The establishment has not been disciplined by a regulatory agency.
1147 (3) No member of the key personnel has done any of the following:
1148 (a) Obtained a license by misrepresentation or fraud.
1149 (b) Attempted to procure, or has procured, a license for any other person by making, or causing
1150 to be made, any false representation.
1151 (c) Been convicted of a crime substantially related to the practice of pharmacy.
1152 (d) Been disciplined by a regulatory agency.
1153 (4) All key personnel must submit fingerprints and other necessary information in order to obtain a report
1154
1155 of the individual’s entire criminal history record from the State Bureau of Identification and from the Federal
1156 Bureau of Investigation pursuant to Federal Bureau of Investigation appropriation of Title II of Public Law 92-544
1157 (28 U.S.C. § 534). If such individuals do not have a criminal history record, the applicant shall cause to be
1158 submitted a statement from each agency that the agency has no record of criminal history information relating to
1159 the individual. The State Bureau of Identification is the intermediary for the purpose of this subsection and the
1160 Board, or its designee, shall be the screening point for the receipt of the federal criminal history record. The
1161 applicant is responsible for the required fee, if any, for obtaining the records.
1162
1163 (5) The application for a license to operate a pharmaceutical establishment must be accompanied by any
1164 application fee or license fee established by the Division. A separate license is required for each location. The
1165 license must be available for inspection by authorized persons.
1166
1167 (6) A license to operate a pharmaceutical establishment issued under this subchapter terminates
1168 automatically upon the termination of the pharmaceutical establishment’s legal existence or upon the
discontinuance of business or professional practice.
(b) Requirements for a manufacturer.
An applicant for licensure as a manufacturer must meet all of the following requirements:
(1) Provide information about ownership and key personnel, including designated representative and
supervisor.
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1169 (2) Provide recent Good Manufacturing Practice (GMP) inspection report which is acceptable to the
1170 Board.
1171
1172 (3) Provide proof of registration pursuant to 21 U.S.C. § 360, where applicable.
1173 (4) Provide proof of licensure or registration by the state in which the manufacturer is physically located,
1174 where applicable.
1175 (5) Meet the applicable requirements set forth in the Board’s rules and regulations.
1176 (c) Requirements for an outsourcing facility.
1177 An applicant for licensure must meet all of the following requirements:
1178 (1) Provide information about ownership and key personnel, including designated representative and
1179 supervisor.
1180 (2) Provide recent Good Manufacturing Practice (GMP) inspection report which is acceptable to the
1181 Board.
1182 (3) Provide proof of licensure or registration by the state in which the manufacturer is physically located,
1183 where applicable.
1184 (4) Meet the applicable requirements set forth in the Board’s rules and regulations.
1185 (d) Requirements for a wholesale distributor.
1186 (1) Provide information about ownership and key personnel, including designated representative and
1187 supervisor.
1188 (2) Provide a set of floor plans for the physical location.
1189 (3) Provide the lease or deed for the physical location.
1190 (4) Provide regulatory letter from the Food and Drug Administration (FDA), where applicable.
1191 (5) Provide proof of licensure or registration by the state in which the wholesale distributor is physically
1192 located, where applicable.
1193 (6) Meet the applicable requirements set forth in the Board’s rules and regulations.
1194 (e) Requirements for a medical gas dispenser.
1195 (1) Provide information about ownership and key personnel, including designated representative and
1196 supervisor.
1197 (2) Provide a set of floor plans for the physical location.
1198 (3) Provide proof of licensure or registration by the state in which the medical gas distributor is physically
located, where applicable.
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1199 (4) Meet the applicable requirements set forth in the Board’s rules and regulations.
1200 § 2541. Application and fee for a permit to operate a pharmaceutical establishment.
1201 (a) The application for a permit to operate a pharmaceutical establishment must be made on a form furnished by
1202 the Board and must be accompanied by an application fee and/or permit fee established pursuant to § 2511 of this title. A
1203 separate permit is required for each location. The permit must be available for inspection by authorized persons. The
1204 Executive Secretary, jointly with the Board president, may issue a temporary, 60-day permit to operate an otherwise
1205 qualified pharmaceutical establishment while the application for a permanent permit is pending. The Board may grant 1 60-
1206 day extension of a temporary permit.
1207 (b) An applicant may not be licensed until its key personnel submit fingerprints and other necessary information in
1208 order to obtain a report of the individuals’ entire criminal history record from the State Bureau of Identification and from
1209 the Federal Bureau of Investigation pursuant to Federal Bureau of Investigation appropriation of Title II of Public Law 92-
1210 544 (28 U.S.C § 534). If the applicant’s key personnel do not have a criminal history record, the applicant shall cause to be
1211 submitted a statement from each agency that the agency has no record of criminal history information relating to the
1212 individual. The State Bureau of Identification shall be the intermediary for the purpose of this subsection and the Board of
1213 Pharmacy, or its designee, shall be the screening point for the receipt of the federal criminal history record. The applicant is
1214 responsible for the required fee, if any, for obtaining the records.
1215 § 2542. Renewal of permit.
1216 A permit to operate a pharmaceutical establishment must be renewed biennially in a manner determined by the
1217 Division, including the payment of the renewal fee established pursuant to § 2511 of this title.
1218 § 2543. Hearings and appeals to Superior Court.
1219 A person aggrieved by a Board decision made pursuant to this subchapter has the substantive and procedural rights
1220 to notice, hearing, and appeal described in § 2531 of this title the Administrative Procedures Act, Chapter 101 of Title 29.
1221 § 2544. Inspections.
1222 Inspections of pharmaceutical establishments are conducted in the same manner as inspections of pharmacies
1223 pursuant to § 2534 of this title and, in addition, include the inspection of and activities related to toilet preparations,
1224 dentifrices, and cosmetics.
1225 § 2545. Penalties. Grounds for discipline.
1226 (a) The Board may suspend or revoke a permit to operate a pharmaceutical establishment if the permit holder
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1227 violates federal law or any state’s law, any of the conditions of the permit, or any of the rules or regulations adopted by the
1228 Board relating to the operation of a pharmaceutical establishment. The Board may impose an administrative penalty of not
1229 more than $50 for each day a violation occurs and/or continues to occur.
1230
1231 (b) A person who commits the offense of operating a pharmaceutical establishment without a permit may be fined
1232 not more than $50 for each day that the offense occurs and/or continues to occur.
1233
1234 (a) The Board may discipline a license to operate a pharmaceutical establishment, other than a pharmacy, where:
1235 (1) The establishment is not being operated according to applicable state and federal law and the Board’s
1236
1237 rules and regulations.
1238 (2) A member of the key personnel has been convicted of a crime substantially related to the practice of
1239
1240 pharmacy.
1241 (3) The establishment or a member of the key personnel has been disciplined by a regulatory agency.
1242 (4) The establishment has obtained a license by misrepresentation or fraud.
1243 (5) The establishment has refused access to the pharmacy or pharmacy records to an agent of the Board who
1244
1245 seeks access for the purpose of conducting an inspection or investigation.
1246 § 2546 Disciplinary sanctions.
1247 (a) The Board may impose any of the following sanctions, individually or in combination, when it finds that 1 or
1248 more of the conditions or violations set forth in § 2545 of this title applies to a pharmaceutical establishment regulated by
1249 this subchapter:
1250
1251 (1) Issue a letter of reprimand.
1252 (2) Place an establishment on probationary status and require the establishment to do any of the
1253 following:
1254
1255 a. Report regularly to the Board upon matters which are related to the basis of the probation.
1256 b. Limit all practice and professional activities as prescribed by the Board.
(3) Suspend any establishment’s license.
(4) Permanently revoke any establishment’s license.
(5) Impose a monetary penalty not to exceed $250,000 for each violation and not more than $250,000 for
each day of a continuing violation.
Subchapter VI. Prohibited Acts; Penalties Generally; Enforcement
§ 2546 2547. Use of certain descriptive titles.
Nothing in this chapter may be construed to prohibit the use of the phrase “proprietary medicine store,” “patent
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1257 medicine store,” or “health and beauty aids. aids,” or “apothecary” but only to the extent that the practice of pharmacy is
1258 not occurring on the premises.
1259
1260 § 2547. Entry and inspection; penalty.
1261 A person who commits the offense of hindering in any manner an entry or inspection under § 2534 or § 2544 of
1262 this title may be fined not more than $500 for each incident.
1263 § 2548. Jurisdiction.
1264 Justices of the peace have jurisdiction over violations of this chapter.
1265 § 2549. Substitution of drugs.
1266 (a) When a pharmacist receives a prescription drug order from a practitioner for a brand or trade name drug, the
1267 pharmacist may dispense a therapeutically equivalent drug if the following conditions are met:
1268
1269 (1) The practitioner, in the case of a written prescription, places that practitioner’s own signature on the
1270 signature line along side or above the words “substitution permitted” pursuant to subsection (c) of this section; or,
1271 in the case of a verbal prescription or a verbal prescription reduced to writing, the practitioner states that the
1272 substitution may be made; or, in the case of an order written in an institution licensed by the Department of Health
1273 and Social Services pursuant to Chapter 10 or Chapter 11 of Title 16, the practitioner has given written
1274 authorization to fill all prescription drug orders with therapeutically equivalent drugs unless otherwise indicated;
1275
1276 (2) The pharmacist informs the patient or the patient’s adult representative that a therapeutically
1277 equivalent drug has been dispensed;
1278
1279 (3) The pharmacist indicates on the prescription and on the prescription label the name of the
1280 manufacturer or distributor of the therapeutically equivalent drug substituted unless the practitioner indicates
1281 otherwise.
1282 (b) Unauthorized dispensing of a therapeutically equivalent drug in violation of this section is punishable by a fine
1283 of not less than $500 nor more than $1,000 or by a term of imprisonment of not less than 30 days nor more than 1 year, or
1284 both a fine and a term of imprisonment.
1285 (c) Every prescription written in this State by a practitioner must be on a prescription form containing a line for the
1286 practitioner’s signature. Alongside or beneath the signature line the words “Substitution Permitted” must be clearly printed.
Beneath the signature line the following statement must be clearly printed:
“In order for a brand name product to be dispensed, the prescriber must handwrite ‘Brand Necessary’ or ‘Brand
Medically Necessary’ in the space below.”
A second line to accommodate the above-mentioned wording must be provided beneath the statement. Prescription
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1287 forms containing the appropriate signature line and statement must be used by every practitioner in this State who
1288 prescribes drugs.
1289
1290 § 2549A. Dispensing and substitution of biological products.
1291 (a) A pharmacist may substitute for a prescribed biological product only if:
1292
1293 (1) The practitioner has not expressly prohibited substitution in a manner specified in § 2549 of this title;
1294 (2) The product to be substituted has been designated by the Federal Food and Drug Administration as
1295 interchangeable with or therapeutically equivalent to the prescribed product;
1296 (3) The pharmacist informs the patient or the patient’s adult representative that an interchangeable
1297 biological product has been dispensed; and
1298 (4) The pharmacist indicates on the prescription and on the prescription label the name of the
1299 manufacturer of the interchangeable biological product substituted unless the practitioner indicates otherwise.
1300 (b) If a biological product is dispensed, the pharmacist or the pharmacist’s designee shall, within a reasonable time
1301 but not to exceed 10 days following dispensing, communicate to the practitioner the name and manufacturer of the
1302 biological product dispensed, by:
1303 (1) Recording such information in an interoperable electronic health records system shared with the
1304 prescribing practitioner, to the extent such a system is in place between a pharmacist and practitioner; or
1305 (2) In the case where electronic health records are not in place between a pharmacist and a practitioner,
1306 communicating such information to the practitioner using any prevailing means available. No communication is
1307 required under this subsection where there is no interchangeable or therapeutically equivalent biological product
1308 for the prescribed biological product, or where a refill prescription is not changed from the biological product
1309 originally dispensed.
1310 (c) The pharmacy shall maintain a record of the biological product dispensed as required in § 2532 of this title.
1311 (d) The Board of Pharmacy shall maintain a link on its web site to the current list of all biological products
1312 determined by the Federal Food and Drug Administration to be interchangeable with a specific biological product.
1313 (e) Hospital pharmacies shall be exempt from the requirements of subsection (b) of this section.
1314 § 2550. Emergency refills of noncontrolled drugs.
1315 (a) A pharmacist may dispense an emergency supply of a noncontrolled drug to a patient whose refill authorization
has expired if:
(1) The supply dispensed is the minimum needed for the emergency period;
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1316 (2) The pharmacist has attempted to reach the prescribing practitioner and has determined that the
1317 prescribing practitioner is not available;
1318
1319 (3) The medication is, in the pharmacist’s professional judgment, essential for the continuation of therapy
1320 for a chronic condition; and
1321
1322 (4) The prescription was originally dispensed at the pharmacy.
1323 (b) If a pharmacist dispenses an emergency supply of a noncontrolled drug pursuant to subsection (a) of this
1324 section:
1325
1326 (1) The refill date, quantity dispensed, and pharmacist’s initials must appear on the patient profile; and
1327 (2) The prescribing practitioner must be notified either in writing or verbally about the pharmacist’s
1328 action, and the date of the notification must be documented on the patient profile.
1329 (c) A prescription may be refilled with an emergency supply pursuant to this section only 1 time.
1330 Subchapter VII. Pharmacy Peer Review
1331 § 2551. Immunity of officials reviewing prescription records and pharmacists’ work.
1332 The members of the Board and pharmacists who are members of pharmacy peer review committees whose functions
1333 are to review prescription records and pharmacists’ work with the view to the validity, quality, and appropriateness of
1334 service are jointly and severally immune from liability for any claim or cause of action, civil and criminal, arising from an
1335 act or omission if the act or omission complained of was done in good faith and without gross or wanton negligence by any
1336 member or members acting individually or jointly in carrying out the responsibilities, authority, duties, powers, and
1337 privileges of the offices conferred by law upon them under this chapter or under any other provision of law or under rules
1338 and regulations of the Board or committees, with good faith being presumed until proven otherwise and with gross or
1339 wanton negligence required to be shown by the complainant.
1340 Subchapter VII. Substitution of drugs; emergency refills
1341 § 2550. Substitution of drugs.
1342 (a) When a pharmacist receives a prescription drug order from a practitioner for a brand or trade name drug, the
1343 pharmacist may dispense a therapeutically equivalent drug if the following conditions are met:
1344 (1) The practitioner, in the case of a written prescription, places that practitioner’s own signature on the
signature line alongside or above the words “substitution permitted” pursuant to subsection (c) of this section; or,
in the case of a verbal prescription or a verbal prescription reduced to writing, the practitioner states that the
substitution may be made; or, in the case of an order written in an institution licensed by the Department of Health
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1345 and Social Services pursuant to Chapter 10 or Chapter 11 of Title 16, the practitioner has given written
1346 authorization to fill all prescription drug orders with therapeutically equivalent drugs unless otherwise indicated.
1347
1348 (2) The pharmacist informs the patient or the patient’s adult representative that a therapeutically
1349 equivalent drug has been dispensed.
1350
1351 (3) The pharmacist indicates on the prescription and on the prescription label the name of the
1352 manufacturer or distributor of the therapeutically equivalent drug substituted unless the practitioner indicates
1353 otherwise.
1354 (b) Unauthorized dispensing of a therapeutically equivalent drug in violation of this section is punishable by a fine
1355 of not less than $500 nor more than $1,000 or by a term of imprisonment of not less than 30 days nor more than 1 year, or
1356 both a fine and a term of imprisonment.
1357 (c) Every prescription in this State that is reduced to writing must be on a prescription form containing a line for
1358 the practitioner’s signature. Alongside or beneath the signature line, the words “Substitution Permitted” must be clearly
1359 printed. Beneath the signature line the following statement must be clearly printed:
1360
1361 “In order for a brand name product to be dispensed, the prescriber must handwrite ‘Brand Necessary’ or
1362 ‘Brand Medically Necessary’ in the space below.”
1363 A second line to accommodate such wording must be provided beneath the statement. Prescription forms
1364 containing the appropriate signature line and statement must be used by every practitioner in this State who prescribes
1365 drugs.
1366 § 2551. Dispensing and substitution of biological products.
1367 (a) A pharmacist may substitute for a prescribed biological product only if:
1368
1369 (1) The practitioner has not expressly prohibited substitution in a manner specified in § 2550 of this title.
1370 (2) The product to be substituted has been designated by the Food and Drug Administration (FDA) as
1371 interchangeable with or therapeutically equivalent to the prescribed product.
1372 (3) The pharmacist informs the patient or the patient’s adult representative that an interchangeable
1373 biological product has been dispensed.
1374 (4) The pharmacist indicates on the prescription and on the prescription label the name of the
manufacturer of the interchangeable biological product substituted unless the practitioner indicates otherwise.
(b) If a biological product is dispensed, the pharmacist or the pharmacist’s designee shall, within a reasonable time
but not to exceed 10 days following dispensing, communicate to the practitioner the name and manufacturer of the
biological dispensed, by one of the following:
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1375 (1) Recording such information in an interoperable electronic health records system shared with the
1376
1377 prescribing practitioner, to the extent such a system is in place between a pharmacist and practitioner.
1378
1379 (2) In the case where electronic health records are not in place between a pharmacist and a practitioner,
1380
1381 communicating such information to the practitioner using any prevailing means available. No communication is
1382
1383 required under this subsection where there is no interchangeable or therapeutically equivalent biological product
1384
1385 for the prescribed biological product or where a refill prescription is not changed from the biological product
1386
1387 originally dispensed.
1388
1389 (c) The pharmacy must maintain a record of the biological product dispensed as required in § 2532 of this title.
(d) The Board shall maintain a link on its website to the current list of all biological products determined by the U.
S. Food and Drug Administration to be interchangeable with a specific biological product.
(e) Hospital pharmacies are exempt from the requirements of subsection (b) of this section.
§ 2552. Emergency refills of noncontrolled drugs.
A pharmacist may dispense an emergency supply of a noncontrolled drug to a patient pursuant to the requirements
set forth in the Board’s rules and regulations.
Section 2. This Act takes effect 1 year after its enactment into law.
SYNOPSIS
The Board of Pharmacy (“Board”) has worked for several years to amend Chapter 25, Title 24 of the Delaware
Code to update the statute governing pharmacy licensure and practice in this State. The result of these efforts is this Act,
which modernizes Chapter 25 to include a licensure system similar to those already in place in many other states, reflects
current practices and standards, and clarifies the law. The Board’s priority in amending Chapter 25 was to ensure
competence and accountability of individuals, pharmacies, and other establishments regulated by the Board.
This Act expands and updates the definitions section to include terms related to current practice, such as
“compounding” and “outsourcing facilities.” Board membership terms are increased: Board members will be eligible to
serve for a maximum of three consecutive, three-year terms. The Board officers are identified as president and vice
president. Several sections are added to the Board’s powers and duties, including the authority to promulgate a Code of
Ethics.
This Act amends the qualifications for licensure as a pharmacist to set forth clearly objective criteria. With respect
to licensure as a pharmacist by reciprocity, the “good standing” requirement is clarified, and a criminal background check
requirement is added. The requirements for license renewal, reinstatement, and reactivation are amended to provide that,
after a certain time period has expired, a licensee will be required to undergo a criminal background check and the
licensee’s disciplinary history will be reviewed.
This Act revises the potential Grounds for Discipline of pharmacists to include violation of the Code of Ethics.
Available sanctions are broadened to include permanent revocation and potential administrative penalties not to exceed
$10,000 for the first violation with further penalties optional for subsequent violations. These changes will serve as a
deterrent for licensee conduct posing a risk to the public health, safety, and welfare.
This Act strikes the provision for “Counseling of Pharmacists” to align statutory language with actual practice.
Disciplinary matters are public and are addressed by the entire Board. The requirements for prescription labeling,
pharmacy closing, and prescription departments will be addressed in rules and regulations to allow for necessary revisions
as practice standards evolve.
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This Act also revises the requirements for pharmacies and non-resident pharmacies in the interest of objectivity
and consistency. Grounds for discipline and available sanctions are expanded. In particular, the Board will have the
discretion to impose an administrative penalty not to exceed $250,000 for each violation with further penalties available for
ongoing violations. Further, with respect to non-resident pharmacies, the Board will also have the authority to impose
administrative penalties, up to $10,000 per day, for the infraction of delivering drugs into Delaware without a license issued
by the Board.
This Act adds a new section for licensure requirements for manufacturers, wholesale distributors, outsourcing
facilities, medical gas distributors, and retail non-pharmacies. Key personnel will be required to undergo criminal
background checks. Possible administrative penalties are revised significantly, from $50 per day, to a maximum of
$250,000 for each violation with further penalties available for ongoing violations. The option of this sanction will serve as
a deterrent for wrongful conduct by establishments that are often delivering drugs from out-of-state into Delaware.
This Act also makes revisions to ensure that statutory provisions are consistent with other Title 24 professional
licensing board practice acts. Technical corrections serve to conform existing law to the standards of the Delaware
Legislative Drafting Manual. This Act takes effect 1 year after enactment.
Author: Senator Poore
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4761530063Every fact on this page links to its source, starting with the official bill record.