SB 180 — AN ACT TO AMEND CHAPTER 25, TITLE 24 OF THE DELAWARE CODE RELATING TO THE BOARD OF PHARMACY.

(2) “Biological product” means a biological product as defined in § 351 of the Public Health Service Act (42 U.S.C.

§ 262) 42 U.S.C.

§ 262.

(2) (3) “Board,” “Board of Pharmacy,” or “State Board of Pharmacy” means the Delaware State Board of Pharmacy.

(3) (4) “Certified pharmacy technician” means a person an individual who is certified by the Pharmacy Technician Certification Board (PTCB) or other entity approved by the Board of Pharmacy.

(4) (5) “Collaborative pharmacy practice” means the practice of pharmacy whereby 1 or more pharmacists provides patient care and drug therapy management services not otherwise permitted to be performed by a pharmacist to patients under a collaborative pharmacy practice agreement(s) agreement with 1 or more practitioners which defines the nature, scope, conditions, and limitations of the services to be provided by the pharmacist(s) pharmacist.

(5) (6) “Collaborative pharmacy practice agreement” means a written and signed agreement between 1 or more pharmacists and 1 or more practitioners that provides for collaborative pharmacy practice.

(7) “Compounding” means the preparation, assembling, packaging, or labeling of a drug as the result of a practitioner’s prescription or initiative based on the relationship of the practitioner or patient with the pharmacist in the course of professional practice or for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing.

Compounding also includes the preparation of drugs in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

All compounding must comply with applicable United States Pharmacopeia (“USP”) standards.

Nothing in this title is meant to limit a prescriber’s ability under pre-existing law to order a compounded medication for use in the prescriber’s practice, as permitted by State and federal law.

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06/06/2025 02:02 PM (8) “Controlled substance” means any drug designated as such under the Uniform Controlled Substances Act, Chapter 47, Title 16 of the Delaware Code and 21 Code of Federal Regulations, Part 1308.

(9) “Deliver” or “deliver” means the actual, constructive, or attempted transfer of a drug from one person to another, whether or not for consideration.

(6) (10) “Direct supervision” means oversight and control by a licensed pharmacist who remains on the premises in the licensed establishment where the pharmacy department is located and is responsible for the work performed by a subordinate support personnel.

(7) (11) “Dispense” or “dispensing” means the procedure involving the interpretation of a practitioner’s prescription order for a drug or biological, and pursuant to that order the proper selection, measuring, compounding, labeling, and packaging in a proper container for subsequent administration to, or use by, a patient means to furnish or deliver a drug to an ultimate user by or pursuant to the lawful prescription of a practitioner.

Dispense includes the preparation, packaging, labeling, or compounding necessary to prepare a drug for furnishing or delivery.

(8) (12) “Division” means the Division of Professional Regulation.

(9) (13) “Drug” means any of the following:

a.

A substance recognized as a drug in the Official United States Pharmacopoeia/National Formulary;

Formulary.

b.

A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of any illness, condition, or disease in humans or animals;

animals.

c.

A substance, other than food, intended to affect the structure or any function of the body of a human or an animal;

or animal.

d.

A substance intended for use as a component of any substance specified in paragraph (8)a., b.

or c.se paragraph a., b., or c., of this section subsection.

“Drug” does not include devices or their components, parts, or accessories.

(10) “Drug outlet” means a pharmacy, an in-state or out-of-state drug wholesaler, a drug manufacturer, a drug distributor, or a nonpharmacy veterinary drug seller.

(11) (14) “Executive Secretary” means the executive secretary of the Delaware State Board of Pharmacy Board, who shall must be a pharmacist.

(12) (15) “Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations” means the publication with that title containing a list of prescription drugs by generic name.

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06/06/2025 02:02 PM 81 drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act.

This is sometimes referred to as the “Orange Book.” (13) (16) “Interchangeable” means a biological product licensed by the Federal Food and Drug Administration pursuant to 42 U.S.C.

§ 262(k)(4) 262.

(14) (17) “Intern” means a person an individual who is registerewd licensed by the Board of Pharmacy and supervised by an approved preceptor and who is completing the practical experience requirement of the Board prior to that person’s licensure as a pharmacist.

(15) (18) “Internship” or “externship” means a period of practical experience established by Board of Pharmacy the Board’s rules and regulations regulation that must be completed by an applicant for a license to practice pharmacy in this State.

(19) “Key personnel” means the designated representative or most senior individual responsible for facility operations, purchasing, and inventory control, the supervisor of such individual, and, if the establishment is not a publicly held company, all principals and owners who directly or indirectly own more than 10% interest in the establishment.

(20) “Label” means written, printed, or graphic matter on the immediate container of a drug.

(21) “Labeling” means the process of affixing a label, including all information required by federal and state statutes or rules and regulations, to a drug container.

The term does not include any of the following:

a.

The labeling by a manufacturer or distributor of a nonprescription drug or commercially packaged prescription drug.

b.

Unit dose packaging.

(16) (22) “Manufacturer” means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a drug, but does not include a person who is engaged in the preparation and dispensing of a drug pursuant to a prescription.

(23) “Manufacturing” means the production, preparation, propagation, conversion, or processing of a drug, either directly or indirectly, by extraction from a substance of natural origin or independently by a chemical or biological synthesis.

The term includes packaging or repackaging a substance or labeling or relabeling a container and promoting and marketing the drug and preparing and promoting a commercially available product from a bulk compound for resale by a person, including a pharmacy or practitioner.

The term does not include compounding.

(17) (24) “Monitoring drug therapy” means interpreting and analyzing information needed to evaluate the safety and efficacy of drug therapy.

(25) “NABP” means the National Association of Boards of Pharmacy or its successor.

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06/06/2025 02:02 PM (26) “Outsourcing facility” means a facility that meets all of the following:

a.

Is located within the United States of America at one address that is engaged in the compounding of sterile drugs or nonsterile drugs.

b.

Has registered as an outsourcing facility with the Food and Drug Administration under § 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

§ 353b).

c.

Is doing business within or into Delaware.

d.

Is licensed with the Board as a wholesaler prior to applying to the Board to become an outsourcing facility.

e.

Is licensed with the Board as an outsourcing facility.

(18) (27) “Over-the-counter product” or “OTC” means a substance which may be sold without a prescription and which is packaged for use by the consumer and labeled in accordance with the requirements of state and federal statutes and regulations.

(28) “Patient counseling” means communication by a pharmacist, or registered intern or pharmacy student under direct supervision, of pertinent drug information, as specified by the Board’s rules and regulations, to a patient or caregiver to improve therapy.

(19) “Person” means a natural person or an entity.

(29) “Person” means as defined in § 302 of Title 1.

(20) (30) “Pharmacist” or “licensee” means an individual licensed by the State pursuant to this chapter to engage in the practice of pharmacy.

(21) (31) “Pharmacy” means a place where drugs are compounded or dispensed the practice of pharmacy occurs.

(22) (32) “Pharmacy technician” means an individual who is not registered as an intern with the Board of Pharmacy or a certified pharmacy technician working in a pharmacy practice site who, under the immediate supervision of a pharmacist, assists in pharmacy activities, as permitted by the rules and regulations of the Board, that do not require the professional judgment of a pharmacist.

(23) (33) “Practice of pharmacy” means the interpreting, evaluating, and dispensing of a practitioner’s or prescriber’s order.

The “practice of pharmacy” includes the proper compounding, labeling, packaging, and dispensing of a drug to a patient or the patient’s agent, and administering a drug to a patient.

The “practice of pharmacy” includes the application of the pharmacist’s knowledge of pharmaceutics, pharmacology, pharmacokinetics, drug and food interactions, drug product selection, and patient counseling.

The “practice of pharmacy” also includes all of the following:

a.

Participation in drug utilization and/or or drug regimen reviews.

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Participation in therapeutic drug selection, substitution of therapeutically equivalent drugproducts drug products.

c.

Advising practitioners and other health-care professionals, as well as patients, regarding the total scope of drug therapy, so as to deliver the best care possible.

d.

Monitoring drug therapy.

e.

Performing and interpreting capillary blood tests to screen and monitor disease risk factors or facilitate patient education, the results of which must be reported to the patient’s health-care practitioner;

screening practitioner.

Screening results to must be reported only if outside normal limits.

f.

Conducting or managing a pharmacy or other business establishment where drugs are compounded or dispensed.

g.

[Repealed.] h.

Administration of injectable medications, biologicals, and immunizations pursuant to a valid prescription from a practitioner or practitioner-approved protocol approved by a physician duly licensed in the State under subchapter III of Chapter 17 of this title or a nurse duly licensed in the State under Chapter 19 of this title.

Upon request, a copy of the protocol will be made available to the designated prescriber or prescribers without cost.

All vaccine administrations shall be reported to DelVAX within 72 hours of administration.

This report to DelVAX shall include the patient’s name, the name of the immunization, inoculations, or vaccinations administered, site of injection, lot and expiration, the facility that provided vaccination, and the date of administration, and shall be submitted electronically.

Pharmacists, pharmacy interns, and nationally-certified pharmacy technicians who have completed an accredited training program, are currently trained in CPR, and have notified the Delaware Board of Pharmacy, may administer immunizations via a prescriber’s order or protocol for patients 3 years of age and older.

i.

Dispensing contraceptives or dispensing and administering injectable hormonal contraceptives under Chapter 30O of Title 16.

j.

Ordering, performing, and interpreting tests authorized by the Food and Drug Administration, and waived under the federal Clinical Laboratory Improvement Amendments of 1988 [42 U.S.C.

§ 263a].

k.

Initiating drug therapy for health conditions in accordance with § 2525 of this title.

l.

Collaborative pharmacy practice in accordance with a collaborative pharmacy practice agreement.

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Initiating, dispensing, or administering medications for human immunodeficiency virus (HIV) pre- exposure prophylaxis and HIV post-exposure prophylaxis under § 2525A of this title, which includes administering laboratory tests, conducting assessments and consultations, and providing referrals.

(24) (34) “Practitioner” or “prescriber” means an individual who is authorized by law to prescribe drugs in the course of professional practice or by collaborative pharmacy practice agreement or research in any state.

(25) (35) “Practitioner-dispensed medication” means a drug that is all of the following:

a.

Dispensed by a practitioner to a patient.

b.

A topical antibiotic, anti-inflammatory, dilation, or glaucoma drop or ointment.

c.

On stand-by or retrieved from a dispensing system for a specified patient for use during a procedure or visit with the practitioner.

(26) (36) “Preceptor” means a licensed pharmacist who is approved by the Board to supervise an intern an individual who is a pharmacist, meets the qualifications under the rules and regulations of the Board, and participates in the instructional training of pharmacy interns and externs.

(27) (37) “Prescription drug” or “legend drug” means a drug required by federal or state law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients, subject to § 503(b) 503B of the Federal Food, Drug and Cosmetic Act (21 U.S.C.

§ 353(b)).

(28) (38) “Prescription drug order” or “prescription” means the lawful written or verbal order of a practitioner for a drug authorization for a drug by a licensed practitioner in written, verbal, electronic, or fax format and must include the information set forth in the Board’s rules and regulations.

(29) (39) “Reference product” means a product as defined by the Federal Food and Drug Administration pursuant to 42 U.S.C.

§ 262.

(30) (40) “State” means the State of Delaware.

(31) (41) “Substantially related” means the nature of the criminal conduct, for which the person was convicted, has a direct bearing on the fitness or ability to perform 1 or more of the duties or responsibilities necessarily related to the practice of pharmacy.

(32) (42) “Substitution” or “substitute” means means a pharmacist’s selection of prescriber authorized generic or therapeutically equivalent prescription medications or, in the case of biologicals, pharmacist a pharmacist’s selection of an interchangeable biological product in place of the prescribed product.

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06/06/2025 02:02 PM classified as being therapeutically equivalent to another drug in the latest edition or supplement of the Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, sometimes referred to as the “Orange Book.” (33) (43) “Therapeutically equivalent drug” means a drug which contains the same active ingredient or ingredients and is identical in strength or concentration, dosage form, and route of administration and which is classified as being therapeutically equivalent to another drug in the latest edition or supplement of the Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, Evaluations, sometimes referred to as the Orange Book.

(34) “Use or abuse of drugs” means:

a.

The use of illegal drugs;

b.

The use of prescription drugs without a prescription;

or c.

The excessive use or abuse of alcoholic beverage or drugs to the extent that it impairs a pharmacist’s ability to perform the work of a pharmacist.

(35) (44) “Wholesale distribution” means the distribution of drugs in compliance with federal laws and regulations, including the Drug Supply Chain Security Act, to a person other than a consumer or patient.

Wholesale distribution patient but does not include any of the following:

a.

The distribution of drugs within a healthcare group-purchasing organization;

organization.

b.

The transfer of prescription drugs by a pharmacy to another pharmacy to alleviate a temporary shortage;

shortage.

c.

The dispensing of a drug pursuant to a prescription;

or prescription.

d.

The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug under any of the following circumstances:

1.

By a charitable organization described in § 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C.

§ 501(c)(3)) to a nonprofit affiliate of the charitable organization to the extent permitted by law;

law.

2.

Among hospitals or other health care entities which are under common control;

control.

3.

For emergency medical reasons.

(36) (45) “Wholesale distributor” “Wholesaler” means a person engaged in the wholesale distribution of drugs, including, but not limited to, a manufacturer’s or distributor’s warehouse, a chain drug warehouse or wholesale drug warehouse, an independent wholesale drug trader, and a pharmacy that engages in the wholesale distribution of drugs.

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06/06/2025 02:02 PM § 2503.

Board of Pharmacy;

appointments;

composition;

qualifications;

terms;

vacancies;

suspension or removal;

unexcused absences;

compensation.

(a) The Delaware State Board of Pharmacy shall administer and enforce this chapter.

(b) The Board consists of 9 members who are appointed by the Governor and Governor, who are residents of the State.

State, and who are comprised as follows:

(1) Six members are pharmacists who have been engaged in the practice of pharmacy in Delaware for at least 5 years and who are representative of the various practice settings in the field of pharmacy.

(2) Three members are public members, 1 from each county.

A public member member:

a.

may May not be, nor ever have been, a pharmacist or a member of the immediate family of a pharmacist;

pharmacist.

b.

may May not be, nor ever have been, employed by a pharmacy;

pharmacy.

c.

may May not have a material interest in the providing of goods or services to a pharmacy;

pharmacy.

and may d.

May not be, nor ever have been, engaged in an activity directly related to the practice of pharmacy.

A public member must e.

Must be accessible to inquiries, comments, and suggestions from the general public.

(c) Except as provided in subsection (d) of this section, each Board member serves a term of 3 years, and may succeed oneself for 1 additional term;

provided, however, that where a member was initially appointed to fill a vacancy, the member may succeed oneself for only 1 additional full term.

A person appointed to fill a vacancy on the Board holds office for the remainder of the unexpired term of the vacating member.

Each term of office expires on the date specified in the appointment;

however, a Board member whose appointment has expired remains eligible to participate in Board proceedings unless or until replaced by the Governor.

Members must be appointed so that the terms of no more than 3 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 term.

Each member is appointed for a term of 3 years and may serve 2 additional, successive terms.

Each term of office expires on the date specified in the appointment;

however, a member remains eligible to participate in Board proceedings until the Governor replaces that member.

(d) A person who has never served on the Board may be appointed to the Board for 2 for 3 consecutive terms;

but that person is thereafter ineligible to serve for 2 consecutive appointments.

A person who has been twice appointed to the 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 an interim period of at least 1 term has expired since the person last served.

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06/06/2025 02:02 PM (e) An act or vote on Board business by a person appointed to the Board in violation of this section is invalid.

(f) The Governor shall suspend or remove a member of the Board for the member’s misfeasance, nonfeasance, malfeasance, misconduct, incompetency, or neglect of duty.

A member subject to a disciplinary hearing must be disqualified from Board business until the charge is adjudicated or the matter is otherwise concluded.

A Board member may appeal to the Superior Court a suspension or removal initiated pursuant to this subsection.

(g) A member of the Board, while serving on the Board, may not hold elective office in any professional association of pharmacists or serve as an officer of a professional association’s political action committee (PAC).

(h) The provisions of the State Employees’, Officers’ and Officials’ Code of Conduct set forth in Chapter 58 of Title 29 apply to the members of the Board.

(i) A member who is absent without adequate reason for 3 consecutive regular business meetings or who fails to attend at leas2 / of all regular business meetings during any calendar year is guilty of neglect of duty.

(j) Each member of the Board shall be reimbursed for all expenses involved in each meeting, including travel, and in addition shall receive compensation per meeting attended in an amount determined by the Division in accordance with Del.

Const.

art.

III, §  9.

(k) The Pharmacy Regulatory Council shall fall under the authority of the Board of Medical Licensure and Discipline and shall consist of 4 pharmacists and 1 member of the public appointed by the Board of Pharmacy, and 2 physicians appointed by the Board of Medical Licensure and Discipline.

One of the physicians shall serve as chairperson of the Council.

Regulations applicable to activities described in §  2502(21)h.

of this title must be approved by the Council.

§ 2504.

Organization;

meetings;

officers;

quorum;

Executive Secretary.

(a) The Board shall elect annually from its membership a President and a Vice President.

Each officer serves for 1 year and may not succeed oneself for more than 2 consecutive terms.

(b) The Board shall hold regularly scheduled business meetings at least 6 times in a calendar year, and at other times as the President of the Board considers necessary, and at the request of a majority of the Board members.

(b) The Board shall elect annually a president and other officers as it considers appropriate and necessary to conduct business.

Each term of office is for 1 year.

An officer may not serve for more than 3 consecutive terms in the same office.

(c) The Executive Secretary, who is an ex officio member of the Board without a vote, is responsible for the performance of the regular administrative functions of the Board and other duties as the Board may direct.

(d) A majority of the members of the Board constitutes a quorum for the purpose of transacting business;

however, no disciplinary action may be taken without the affirmative vote of at least 5 members.

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06/06/2025 02:02 PM (e) Minutes of all meetings must be recorded.

The Executive Secretary shall maintain copies of the recorded minutes.

At any hearing where evidence is presented, a record from which a verbatim transcript can be prepared must be made.

The person requesting a transcript incurs the expense of preparing the transcript.

§ 2505.

Records.

The Executive Secretary Division shall must keep complete records relating to meetings of the Board, examinations, rosters of licensees and permit holders, changes and additions to the Board’s rules and regulations, complaints, hearings, and other matters as the Board determines.

Records kept in accord with this section are prima facie evidence of the proceedings of the Board.

§ 2506.

Authority of the Board.

Powers and duties.

(a) The Board of Pharmacy has the authority to:

(1) Promulgate rules and regulations not inconsistent with § 2501(a) of this title in accordance with the procedures specified in the Administrative Procedures Act [Chapter 101 of Title 29];

in Chapter 101 of Title 29.

(2) Designate the application form to be used by all applicants and to process Process all applications pursuant to this chapter;

chapter.

(3) Designate the national standardized examinations in pharmacy and jurisprudence as approved by the National Association of Boards of Pharmacy, or its successor, to be taken by a person an individual applying for a license to practice pharmacy;

pharmacy.

(4) Evaluate the credentials of each person individual applying for a license to practice pharmacy in order to determine whether the person individual meets the qualifications set forth in this chapter;

chapter.

(5) Grant a license to and renew the license of each person individual who qualifies for a license to practice pharmacy;

and grant or renew a license with restrictions, if appropriate, as a reasonable accommodation to an applicant with a disability;

licensure and renew licenses as appropriate.

(6) Evaluate applications and issue licenses to pharmacies and other establishments that meet the qualifications set forth in this chapter.

(6) (7) Establish by regulation continuing education standards required for license renewal;

renewal.

(8) Perform random audits of continuing education credits submitted by licensees for license renewal.

(7) (9) Evaluate certified records, including criminal history records, to determine whether an applicant for licensure who previously has been licensed, certified, or registered in another jurisdiction to practice pharmacy has engaged in any act or offense that would be grounds for disciplinary action under this chapter and whether SD :

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06/06/2025 02:02 PM there are disciplinary proceedings or unresolved complaints pending against the applicant for such acts or offenses;

chapter.

(8) Maintain a registry of interns;

(9) (10) Refer all complaints from licensees and the public concerning persons licensed under this chapter, or concerning the practices of the Board or the profession, to the Division for investigation pursuant to §  8735 of Title 29 and assign a member of the Board to assist the Division in an advisory capacity with the investigation for the technical aspects of the complaint;

complaint.

(10) Issue subpoenas to require the attendance of persons and the production of books and papers for the purpose of conducting investigations preliminary to hearings and for the purpose of eliciting testimony at hearings.

A person who is subpoenaed may be required to testify in any and all matters within the jurisdiction of the Board.

Subpoenas may be issued by the Director of the Division of Professional Regulation or the Executive Secretary of the Board and are enforceable by the Superior Court;

(11) Conduct hearings and issue orders in accordance with the procedures established in the Administrative Procedures Act in Chapter 101 of Title 29;

29.

(12) Designate and impose an appropriate sanction or penalty, if it has been determined after a hearing that a sanction or penalty should be imposed;

imposed.

(13) Evaluate applications and issue permits to pharmacies or other establishments, as provided under this chapter;

(14) (13) Join professional organizations and associations organized exclusively to promote the improvement of the standards of the practice of pharmacy for the protection of the health, safety, and welfare of the public and whose activities assist and facilitate the work of the Board, and pay annual dues to the organizations and associations joined;

joined.

(15) (14) Regulate the sale and dispensing of drugs and other materials, including the right to seize any drugs and other materials found by the Executive Secretary or other agent of the Board to be detrimental to the public health, safety, or welfare, in accordance with Chapter 33 of Title 16;

§ 3315 of Title 16.

(16) (15) Regulate the purity and quality of drugs and other materials within the practice of pharmacy;

pharmacy.

(17) (16) Promulgate rules and regulations to implement the law relating to pure drugs, pursuant to §  3315 of Title 16;

16.

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06/06/2025 02:02 PM (18) Appoint public members and pharmacists to the Pharmacy Regulatory Council of the Board of Medical Licensure and Discipline.

(17) Seize any drugs found by the Board or Executive Secretary to constitute an imminent danger to the public health and welfare.

(18) Establish by rule and regulation minimum specifications for record keeping, prescription and patient profile record maintenance, monitoring of drug therapy, and pharmacy practice sites including the physical premises, technical equipment, environment, supplies, personnel, and procedures for the storage, compounding, and dispensing of drugs.

(19) Inspect any pharmacy for the purpose of determining if any provision of the laws governing the legal distribution of drugs or the practice of pharmacy are being violated.

(20) Appoint advisory committees as the Board determines to be appropriate.

(21) Promulgate a Code of Ethics by rule and regulation.

(b) The Board of Pharmacy shall promulgate regulations specifically identifying those crimes, crimes which are substantially related to the practice of pharmacy.

(c) The Board shall submit a written report to the Governor within 3 months after the conclusion of each fiscal year and shall make the report available to anyone requesting a copy.

Subchapter II.

Licensure of pharmacists and interns § 2507.

License required.

(a) A person An individual may not, in this State, engage in the practice of pharmacy or hold himself or herself oneself out to the public as being qualified to practice pharmacy, or use in connection with that person’s individual’s own name, or otherwise assume or use, a title or description conveying or tending to convey the impression that the person individual is qualified to practice pharmacy, except as provided in this chapter.

(b) No person individual who has not been issued a certificate as a pharmacist or who is not a pharmacy intern, or a pharmacy student participating in an approved College of Pharmacy coordinated practical experience program under the direct supervision of a licensed pharmacist, within the meaning of this chapter, shall may certify a prescription, perform drug utilization reviews, provide drug information requiring clinical or technical knowledge, counsel patients, receive new verbal prescription orders without recorded backup, or contact a prescriber concerning prescription drug order interpretation or therapy modification.

Other responsibilities may be delegated to a certified pharmacy technician or pharmacy technicians who are under the direct supervision of a pharmacist.

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06/06/2025 02:02 PM (c) It is unlawful for a person an individual to practice pharmacy in this State if the person’s individual’s license to practice pharmacy expires, is placed on inactive status, or is suspended or revoked.

(d) The penalty for a violation of this section is, for a first conviction, a fine of not less than $500 nor more than $1000, and for a second or subsequent conviction, a fine of not less than $1000 nor more than $2000.

§ 2508.

Qualifications of applicant;

judicial review;

report to Attorney General.

(a) An applicant for a license to practice pharmacy must submit evidence, verified by oath or affirmation and satisfactory to the Board, that the applicant has completed the requirements for graduation from a school or college of pharmacy accredited by the American Council on Pharmaceutical Education;

or, if the applicant is a graduate of a foreign school or college of pharmacy, that the applicant graduated and received a pharmacy degree from a pharmacy degree program which has been approved by the Board.

(b) An applicant for a license to practice pharmacy must obtain practical experience in the practice of pharmacy during and/or after attendance at a school or college of pharmacy, under such terms and conditions as the Board determines.

The Board shall also determine the necessary qualifications for preceptors used in internships or other programs.

(c) The Board shall determine whether an applicant whose conduct or status is described in 1 or more of the following paragraphs of this subsection is qualified to engage in the practice of pharmacy.

In making this determination, the Board shall consider whether the applicant’s conduct is or is not related to the practice of pharmacy and whether licensure of the applicant will or will not present a risk to public health, safety, or welfare, and shall conduct its analysis of criminal history records consistent with the provisions of § 8735(x) of Title 29.

(1) The applicant received an administrative penalty regarding the practice of pharmacy, including but not limited to fines, formal reprimands, license suspension or revocation (except for license revocation for nonpayment of license renewal fees), probationary limitations, or entry into a consent agreement which contains conditions placed by a Board on the applicant’s professional conduct and practice, including the voluntary surrender of the applicant’s license to practice pharmacy.

(2) The applicant has an impairment related to drugs, alcohol, or mental competence.

(3) The applicant has a criminal conviction record or a pending criminal charge related to a crime that is substantially related to the practice of pharmacy.

However, after a hearing or review of documentation and consideration of the factors set forth in § 8735(x)(3) of Title 29, the Board by an affirmative vote of a majority of the quorum, shall waive this paragraph (c)(3), if it finds that granting a waiver would not create an unreasonable risk to public safety.

a.-d.

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06/06/2025 02:02 PM (a) An applicant who is applying for licensure as a pharmacist under this chapter shall submit evidence, verified by oath and satisfactory to the Board, that the applicant meets all of the following requirements:

(1) Has completed the requirements for graduation from a school or college of pharmacy accredited by the American Council on Pharmaceutical Education;

or, if the applicant was educated outside of the United States or its territories, has met the education requirements set forth in the Board’s rules and regulations.

(2) Has obtained practical experience as an intern in the practice of pharmacy during or after attendance at a school or college of pharmacy, under such terms and conditions as set forth in the Board’s rules and regulations.

(3) Has received a passing score on the North American Pharmacist Licensure Examination (NAPLEX) as developed and approved by NABP or its successor.

(4) Has received a passing score on a jurisprudence examination as set forth in the Board’s rules and regulations.

(5) Has not receive an administrative penalty regarding the practice of pharmacy, including formal reprimands, license suspension or revocation (except for license revocation for nonpayment of license renewal fees), probationary limitations, or entry into a consent agreement which contains conditions placed by a Board on the applicant’s professional conduct and practice, including the voluntary surrender of the applicant’s license to practice pharmacy.

(6) Does not have a current condition that impairs the applicant’s judgment or adversely affects the applicant’s ability to practice safely and in a competent, ethical, and professional manner.

(7) The applicant has a criminal conviction record or a pending criminal charge related to a crime that is substantially related to the practice of pharmacy.

However, after a hearing or review of documentation and consideration of the factors set forth in § 8735(x)(3) of Title 29, the Board by an affirmative vote of a majority of the quorum, may waive this paragraph if it finds that granting a waiver would not create an unreasonable risk to public safety.

(b) An applicant for licensure as an intern must meet the following requirements:

(1) The applicant must submit an “Application for Registration of Internship” after entering the first professional year at a school or college of pharmacy accredited by the American Council on Pharmaceutical Education.

The application must include an “Affidavit of Class Standing” form and an “Affidavit of Preceptor” form.

The application and requisite forms are set forth by the Board or the Division.

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06/06/2025 02:02 PM (2) If the applicant was educated outside of the United States or its territories, the applicant must meet the education requirements set forth in the Board’s rules and regulations.

(3) The applicant has not received an administrative penalty regarding the practice of pharmacy, including formal reprimands, license suspension or revocation (except for license revocation for nonpayment of license renewal fees), probationary limitations, or entry into a consent agreement which contains conditions placed by a Board on the applicant’s professional conduct and practice, including the voluntary surrender of the applicant’s license to practice pharmacy.

(4) Does not have a current condition that impairs the applicant’s judgment or adversely affects the applicant’s ability to practice safely and in a competent, ethical, and professional manner.

(5) The applicant has a criminal conviction record or a pending criminal charge related to a crime that is substantially related to the practice of pharmacy.

However, after a hearing or review of documentation and consideration of the factors set forth in § 8735(x)(3) of Title 29, the Board by an affirmative vote of a majority of the quorum, may waive this paragraph if it finds that granting a waiver would not create an unreasonable risk to public safety.

(d) (c) An applicant shall submit fingerprints and other necessary information in order to obtain a report of the individual’s entire criminal history record from the State Bureau of Identification and from the Federal Bureau of Investigation pursuant to Federal Bureau of Investigation appropriation of Title II of Public Law 92-544 (28 U.S.C § 534).

If the applicant does not have a criminal history record, the applicant shall cause to be submitted a statement from each agency that the agency has no record of criminal history information relating to the applicant.

The State Bureau of Identification shall be is the intermediary for the purpose of this subsection and the Board, or its designee, shall be is the screening point for the receipt of the federal criminal history record.

The applicant is responsible for the required fee, if any, for obtaining the records.

(e) (d) If the Board finds that false information has been intentionally provided to the Board, it shall report its finding to the Attorney General’s Office for further action.

(f) (e) If the Board refuses to accept, or rejects, an application and the applicant believes that the Board acted without justification, justification or imposed higher or different standards for the applicant than for other applicants, or in some other unlawful manner contributed to or caused the refusal or rejection of the application, the applicant may appeal to the Superior Court.

§ 2509.

Examination.

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06/06/2025 02:02 PM (a) The Board shall adopt the administration, grading procedures, and passing score of the North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (MPJE) or of comparable alternative national examinations.

(b) The Board shall determine in its rules and regulations the frequency and conditions under which a candidate may retest after a failure.

§ 2510.

Reciprocity or license transfer.

(a) The Board shall grant a license to practice pharmacy to a reciprocal applicant who pays the appropriate fee, submits a completed application on forms provided by the Board and which completed application is accepted by the Board, and who otherwise qualifies pursuant to subsection (b) of this section and sends proof to the Board that:

(a) Upon payment of the appropriate fee and submission of an application, the Board shall grant a license to each applicant who presents proof of current licensure, in good standing, in another state, the District of Columbia, or territory of the United States and who, in addition:

(1) The reciprocal applicant’s current licensure is in good standing in another state, the District of Columbia, or a territory of the United States;

(1) Meets the criteria for licensure in good standing as defined in § 2508(a)(5)-(7) in all states in which the applicant is or was licensed.

(2) The reciprocal applicant Has passed the NAPLEX and MPJE or a comparable alternative national examination adopted accepted by the Board for this State;

and Board.

(3) Has received a passing score on a jurisprudence examination as set forth in the Board’s rules and regulations.

(4) The reciprocal applicant Has passed the examination of the Foreign Pharmacy Graduate Examination Committee (FPGEC) of the National Association of Boards of Pharmacy Foundation (NABP) NABP, if the applicant is a graduate of a foreign school of pharmacy.

(5) Has submitted fingerprints and other necessary information in order to obtain a report of the individual’s entire criminal history record from the State Bureau of Identification and from the Federal Bureau of Investigation pursuant to Federal Bureau of Investigation appropriation of Title II of Public Law 92-544 (28 U.S.C § 534).

If the applicant does not have a criminal history record, the applicant shall cause to be submitted a statement from each agency that the agency has no record of criminal history information relating to the applicant.

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06/06/2025 02:02 PM designee, is the screening point for the receipt of the federal criminal history record.

The applicant is responsible for the required fee, if any, for obtaining the records.

(b) The provisions of § 2508(c), (d), (e), and (f) of this title apply to reciprocal applicants.

If a disciplinary proceeding or unresolved complaint is pending against a reciprocal applicant, the reciprocal applicant may not be licensed in this State until the proceeding or complaint has been resolved to the satisfaction of the Board.

A reciprocal applicant for licensure in this State is deemed to have given consent to the release of information regarding disciplinary proceedings and unresolved complaints and to have waived all objections to the admissibility of the information as evidence at any hearing or other proceeding to which the reciprocal applicant may be subjected.

(c) (b) A reciprocal applicant is not required to obtain the practical experience pursuant to § 2508(b) required under § 2508(a) of this title.

§ 2511.

Fees.

The amount charged by the Division for each fee imposed under this chapter must approximate and reasonably reflect the cost necessary to defray the expenses of the Board as well as the proportional expenses incurred by the Division in its services or activities on behalf of the Board.

A separate fee may be charged for each service or activity.

At the beginning of each licensure biennium, the Division, or a state agency acting on its behalf, shall compute and set the fee for the licensure biennium.

§ 2512.

Issuance and renewal of license;

reinstatement;

inactive status.

(a) The Board shall issue a license to each applicant who meets the requirements of this chapter and the Board’s rules and regulations for licensure to practice pharmacy and who pays the required fee established under § 2511 of this title.

(b) A license to practice pharmacy must be renewed biennially, in a manner determined by the Division, and must include payment of the appropriate fee and attestation that the licensee has met the continuing education requirements established by the Board.

(c) A licensee who has allowed that licensee’s license to lapse for more than 1 year but for less than 4 years may renew such lapsed license upon completion of all of the following:

(1) Payment of a late fee established by the Division.

(2) Providing proof that the licensee has met any continuing education requirements established by the Board.

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06/06/2025 02:02 PM (3) Submission of fingerprints and other necessary information in order to obtain a report of the individual’s entire criminal history record from the State Bureau of Identification and from the Federal Bureau of Investigation.

(4) Review of NABP clearinghouse for discipline in other jurisdictions.

(d) A licensee who has allowed that licensee’s license to lapse for longer than 4 years may reinstate such license upon completion of all of the following:

(1) Payment of a late fee established by the Division.

(2) Providing proof that the licensee has met any continuing education requirements established by the Board.

(3) Submission of fingerprints and other necessary information in order to obtain a report of the individual’s entire criminal history record from the State Bureau of Identification and from the Federal Bureau of Investigation.

(4) Review of NABP clearinghouse for discipline in other jurisdictions.

(5) Proof of re-taking and passing the MPJE.

(e) Any licensee, upon written request, may be placed in an inactive status for up to 4 years, and the licensee may reactivate the license after meeting all of the following criteria:

(1) Providing the Board with written notification that the licensee intends to reactivate the license.

(2) Satisfying all the continuing education requirements set forth in the Board’s rules and regulations.

(3) Paying the appropriate renewal fee.

(4) Submitting fingerprints and other necessary information in order to obtain a report of the individual’s entire criminal history record from the State Bureau of Identification and from the Federal Bureau of Investigation.

(5) Review by the Division or the Board of the NABP clearinghouse for discipline in other jurisdictions.

(f) If a licensee who has been placed on inactive status under subsection (e) of this section fails to reactivate that license within 4 years of being placed on inactive status under subsection (e) of this section, the individual must reapply for licensure and re-take and pass the MPJE.

(b) A license to practice pharmacy must be renewed biennially, in a manner determined by the Division.

License renewal must include the completion and submission of a renewal form provided by the Division, payment of the appropriate fee, and proof that the licensee has met the continuing education requirements established by the Board.

(c) The Board shall not renew any license to any applicant unless and until the applicant has offered proof that the applicant has completed continuing professional education relating to:

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06/06/2025 02:02 PM (1) The distribution, dispensing or delivery of controlled substances, as defined in this chapter;

or (2) The detection and recognition of symptoms, patterns of behavior, or other characteristic of impairment and dependency resulting from the abusive or illegal use of controlled substances;

and (3) Other topics as the Board deems appropriate.

(d) The Board, in its rules and regulations, shall determine the period of time within which a licensee may renew that licensee’s own license, notwithstanding the fact that the licensee failed to renew that licensee’s own license on or before the designated renewal date;

provided, however, that the period of time may not exceed 1 year beyond the designated renewal date.

(e) A licensee, upon the licensee’s written request, may be placed on inactive status for no more than 4 years.

A licensee on inactive status who desires to reactivate that licensee’s own license shall complete and submit an application form approved by the Board, submit the renewal fee set by the Division, and submit proof of fulfillment of the continuing education requirements established by the Board.

(f) If a licensee is on inactive status for more than 4 years, that licensee may be relicensed, but only by following the reentry process established by the Board in its rules and regulations.

§ 2513.

Temporary license.

The Executive Secretary may issue a temporary, 90-day license to practice pharmacy to a person who has made application for a permanent license and whose application is pending.

In issuing a temporary, 90-day license, the Board may impose conditions as it considers appropriate, including, but not limited to, restrictions on the practice of pharmacy.

The Board may grant 1 90-day extension of a temporary license.

[REPEALED] § 2514.

Complaints.

(a) All complaints received by the Division must be investigated in accordance with § 8735 of Title 29.

(b) If the Board determines that a person is engaging in or has engaged in the practice of pharmacy or is using the title “pharmacist” and is not licensed to practice pharmacy pursuant to § 2507 of this title this Chapter, the Board shall request that the Office of the Attorney General issue a cease and desist order and take any other further appropriate action.

§ 2515.

Grounds for discipline.

(a) A pharmacist licensed under this chapter is subject to disciplinary sanctions set forth in § 2516 of this title if, after a hearing, the Board finds that the pharmacist has done any of the following: