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Del. Code tit. 24 ch. 25
Chapter 25
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§ 2501 Objectives of the Board.
(a) The primary objective of the Board of Pharmacy, to which all other objectives and purposes are secondary, is to protect the general public, specifically those individuals who are the direct recipients of services regulated by this chapter, from unsafe practices and from occupational practices which reduce competition or fix the price of services rendered.
(b) The secondary objectives of the Board are to maintain minimum standards of licensee competency and to maintain certain standards in the delivery of services to the public. In meeting these objectives, the Board shall do all of the following:
(1) Develop standards assuring professional competence.
(2) Monitor complaints brought against licensees regulated by the Board.
(3) Adjudicate at formal hearings.
(4) Promulgate rules and regulations.
(5) Impose sanctions where necessary. 68 Del. Laws, c. 206,
§
1 ;
76 Del. Laws, c. 167,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2502 Definitions [For application of this section, see 83 Del. Laws, c. 240, § 3; 85 Del. Laws, c. 418, § 6].
For purposes of this chapter:
(1) “Administer” means the direct application of a prescription drug, whether by injection, inhalation, ingestion, or any other means, to the body of a patient by any of the following:
a. An individual authorized by law to administer the drug, including a practitioner or an authorized agent under a practitioner’s supervision.
b. The patient at the direction of a practitioner.
(2) “Biological product” means a biological product as defined in 42 U.S.C. § 262.
(3) “Board” means the Delaware Board of Pharmacy.
(4) “Certified pharmacy technician” means an individual who is certified by the Pharmacy Technician Certification Board (PTCB) or other entity approved by the Board.
(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 with 1 or more practitioners which defines the nature, scope, conditions, and limitations of the services to be provided by the pharmacist.
(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 of Delaware and federal law.
(8) “Controlled substance” means any drug designated as such under the Uniform Controlled Substances Act, Chapter 47 of Title 16 and 21 C.F.R. Part 1308.
(9) “Deliver” or “deliver” means the actual, constructive, or attempted transfer of a drug from 1 person to another, whether or not for consideration.
(10) “Direct supervision” means oversight and control by a licensed pharmacist who remains in the licensed establishment where the pharmacy department is located and is responsible for the work performed by support personnel.
(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.
(12) “Division” means the Division of Professional Regulation.
(13) “Drug” means any of the following:
a. A substance recognized as a drug in the Official United States Pharmacopoeia/National 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.
c. A substance, other than food, intended to affect the structure or any function of the body of a human or an animal.
d. A substance intended for use as a component of any substance specified in paragraph (13)a., b., or c. of this section.
“Drug” does not include devices or their components, parts, or accessories.
(14) “Executive Secretary” means the Executive Secretary of the Board, who must be a pharmacist.
(15) “Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations” means the publication that identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 301 et seq.]. This is sometimes referred to as the “Orange Book.”
(16) “Interchangeable” means a biological product licensed by the Federal Food and Drug Administration pursuant to 42 U.S.C. § 262.
(17) “Intern” means an individual who is licensed by the Board 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.
(18) “Internship” or “externship” means a period of practical experience established by the Board’s rules and regulations 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.
(22) “Manufacturer” means a person who is engaged in manufacturing, 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.
(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.
(26) “Outsourcing facility” means a facility that meets all of the following:
a. Is located within the United States of America at 1 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.
(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.
(29) “Person” means as defined in § 302 of Title 1.
(30) “Pharmacist” or “licensee” means an individual licensed by this State pursuant to this chapter to engage in the practice of pharmacy.
(31) “Pharmacy” means a place where the practice of pharmacy occurs.
(32) “Pharmacy technician” means an individual 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.
(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 practices that fall within the scope of practice of a pharmacist as established by subchapter VIII of this chapter.
(a)-(m) [Repealed.]
(34) a. “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.
b. A pharmacist licensed under this chapter is deemed a practitioner or prescriber when prescribing drugs or ordering laboratory tests in accordance with this chapter’s definition of the practice of pharmacy.
(35) “Practitioner-dispensed topical 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.
(36) “Preceptor” means 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.
(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) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 353(b)).
(38) “Prescription drug order” or “prescription” means the lawful 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.
(39) “Reference product” means a product as defined by the Federal Food and Drug Administration pursuant to 42 U.S.C. § 262.
(40) “State” means the State of Delaware.
(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.
(42) “Substitution” or “substitute” means a pharmacist’s selection of prescriber authorized generic or therapeutically equivalent prescription medications or, in the case of biologicals, a pharmacist’s selection of an interchangeable biological product in place of the prescribed product. “Generic substitute” means a drug that is the same active ingredient, equivalent in strength to the strength written on the prescription, 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.
(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.
(44) “Wholesale distribution” means the distribution of drugs in compliance with federal laws and regulations, including the Drug Supply Chain Security Act [P.L. 113-54], to a person other than a consumer or patient but does not include any of the following:
a. The distribution of drugs within a healthcare group-purchasing organization.
b. The transfer of prescription drugs by a pharmacy to another pharmacy to alleviate a temporary shortage.
c. The dispensing of a drug pursuant to a 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.
2. Among hospitals or other health care entities which are under common control.
3. For emergency medical reasons.
(45) “Wholesaler” means a person engaged in the wholesale distribution of drugs, including, 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. 68 Del. Laws, c. 206,
§
1 ;
70 Del. Laws, c. 186,
§
1 ;
71 Del. Laws, c. 412,
§
1 ;
74 Del. Laws, c. 262,
§
42 ;
76 Del. Laws, c. 167,
§
1 ;
79 Del. Laws, c. 238,
§
1 ;
80 Del. Laws, c. 80,
§
13 ;
82 Del. Laws, c. 261,
§§
11, 16 ;
83 Del. Laws, c. 52,
§
14 ;
83 Del. Laws, c. 240,
§
2 ;
83 Del. Laws, c. 439,
§
1 ;
84 Del. Laws, c. 158,
§
1 ;
84 Del. Laws, c. 169,
§
1 ;
84 Del. Laws, c. 424,
§
1 ;
84 Del. Laws, c. 514,
§
44 ;
85 Del. Laws, c. 49,
§
1 ;
85 Del. Laws, c. 418,
§§
3, 4 ;
§ 2503 Board of Pharmacy; appointments; composition; qualifications; terms; vacancies; suspension or removal; unexcused absences; compensation.
(a) The Board shall administer and enforce this chapter.
(b) The Board consists of 9 members who are appointed by the Governor, who are residents of this 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. A public member:
a. May not be, nor ever have been, a pharmacist or a member of the immediate family of a pharmacist.
b. May not be, nor ever have been, employed by a pharmacy.
c. May not have a material interest in the providing of goods or services to a pharmacy.
d. May not be, nor ever have been, engaged in an activity directly related to the practice of pharmacy.
e. Must be accessible to inquiries, comments, and suggestions from the general public.
(c) 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 3 consecutive terms; but that person is thereafter ineligible to serve for 2 consecutive appointments.
(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 least 1 / 2 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. 24 Del. Laws, c. 140,
§§
7, 10 ;
Code 1915,
§§
856, 859;
36 Del. Laws, c. 103,
§
1 ;
Code 1935,
§
936;
45 Del. Laws, c. 90,
§
2 ;
24 Del. C. 1953,
§§
2501, 2505;
53 Del. Laws, c. 90,
§§
1, 3 ;
59 Del. Laws, c. 318,
§
1 ;
60 Del. Laws, c. 586,
§§
1, 2 ;
62 Del. Laws, c. 251,
§§
2, 3 ;
65 Del. Laws, c. 378,
§
1 ;
67 Del. Laws, c. 366,
§
7 ;
67 Del. Laws, c. 368,
§
13 ;
68 Del. Laws, c. 206,
§
1 ;
70 Del. Laws, c. 186,
§
1 ;
76 Del. Laws, c. 167,
§
1 ;
77 Del. Laws, c. 319,
§
1 ;
79 Del. Laws, c. 238,
§
1 ;
80 Del. Laws, c. 80,
§
13 ;
81 Del. Laws, c. 85,
§
12 ;
83 Del. Laws, c. 52,
§
14 ;
84 Del. Laws, c. 42,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 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.
(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.
(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. 24 Del. Laws, c. 140,
§
8 ;
Code 1915,
§
857;
Code 1935,
§
937;
45 Del. Laws, c. 90,
§
1 ;
24 Del. C. 1953,
§
2502;
59 Del. Laws, c. 318,
§
2 ;
68 Del. Laws, c. 206,
§
1 ;
70 Del. Laws, c. 186,
§
1 ;
76 Del. Laws, c. 167,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2505 Records.
The Division must keep complete records relating to meetings of the Board, examinations, rosters of licensees, 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. 76 Del. Laws, c. 167,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2506 Powers and duties.
(a) The Board 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 in Chapter 101 of Title 29.
(2) Process all applications pursuant to this 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 an individual applying for a license to practice pharmacy.
(4) Evaluate the credentials of each individual applying for a license to practice pharmacy in order to determine whether the individual meets the qualifications set forth in this chapter.
(5) Grant a license to each individual who qualifies for 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.
(7) Establish by regulation continuing education standards required for license renewal.
(8) Perform random audits of continuing education credits submitted by licensees for license renewal.
(9) Evaluate certified 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.
(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.
(11) Conduct hearings and issue orders in accordance with the procedures established in the Administrative Procedures Act in Chapter 101 of Title 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.
(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.
(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 § 3315 of Title 16.
(15) Regulate the purity and quality of drugs and other materials within the practice of pharmacy.
(16) Promulgate rules and regulations to implement the law relating to pure drugs, pursuant to § 3315 of Title 16.
(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 which are substantially related to the practice of pharmacy. 24 Del. Laws, c. 140,
§§
9, 12 ;
24 Del. Laws, c. 141,
§§
1, 2 ;
Code 1915,
§§
858, 861, 868, 875;
28 Del. Laws, c. 62 ;
29 Del. Laws, c. 55 ;
36 Del. Laws, c. 103,
§
1 ;
Code 1935,
§§
938, 941, 948, 956;
43 Del. Laws, c. 95,
§
1 ;
45 Del. Laws, c. 90,
§
3 ;
46 Del. Laws, c. 95,
§
3 ;
24 Del. C. 1953,
§§
2503, 2506, 2507, 2509;
53 Del. Laws, c. 90,
§§
4, 272 ;
53 Del. Laws, c. 108,
§
27 ;
55 Del. Laws, c. 316,
§
3 ;
62 Del. Laws, c. 251,
§§
1, 4, 5 ;
64 Del. Laws, c. 452,
§
2 ;
65 Del. Laws, c. 378,
§
2 ;
68 Del. Laws, c. 206,
§
1 ;
72 Del. Laws, c. 159,
§
1 ;
74 Del. Laws, c. 262,
§
43 ;
76 Del. Laws, c. 167,
§
1 ;
77 Del. Laws, c. 319,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
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§ 2507 License required.
(a) An individual may not, in this State, engage in the practice of pharmacy or hold oneself out to the public as being qualified to practice pharmacy, or use in connection with that individual’s own name, or otherwise assume or use, a title or description conveying or tending to convey the impression that the individual is qualified to practice pharmacy, except as provided in this chapter.
(b) No 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, 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.
(c) It is unlawful for an individual to practice pharmacy in this State if the 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. 24 Del. Laws, c. 140,
§
1 ;
Code 1915,
§
862;
Code 1935,
§
942;
24 Del. C. 1953,
§
2521;
64 Del. Laws, c. 452,
§
1 ;
68 Del. Laws, c. 206,
§
1 ;
70 Del. Laws, c. 186,
§
1 ;
75 Del. Laws, c. 161,
§
9 ;
75 Del. Laws, c. 260,
§§
1, 2 ;
76 Del. Laws, c. 167,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2508 Qualifications of applicant; judicial review; report to Attorney General.
(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. The Board may, after a hearing or review of documentation, determine whether such administrative penalty is grounds to deny licensure.
(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 does not have 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.
(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. The Board may, after a hearing or review of documentation, determine whether such administrative penalty is grounds to deny licensure.
(4) The applicant 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 does not have 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.
(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 is the intermediary for the purpose of this subsection and the Board, or its 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.
(d) If the Board finds that false information has been intentionally provided to the Board, it shall report its finding to the Attorney General for further action.
(e) If the Board refuses to accept, or rejects, an application and the applicant believes that the Board acted without 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. 24 Del. Laws, c. 140,
§§
2,3 ;
Code 1915,
§§
863, 864;
35 Del. Laws, c. 56,
§
1 ;
Code 1935,
§§
943, 944;
41 Del. Laws, c. 87,
§
1 ;
42 Del. Laws, c. 91,
§
1 ;
46 Del. Laws, c. 95,
§§
1, 2 ;
24 Del. C. 1953,
§§
2522, 2523;
53 Del. Laws, c. 90,
§§
6,7 ;
58 Del. Laws, c. 511,
§
57 ;
59 Del. Laws, c. 318,
§
3 ;
62 Del. Laws, c. 251,
§
6 ;
64 Del. Laws, c. 167,
§
1 ;
65 Del. Laws, c. 378,
§
3 ;
68 Del. Laws, c. 206,
§
1 ;
70 Del. Laws, c. 186,
§
1 ;
75 Del. Laws, c. 436,
§
22 ;
76 Del. Laws, c. 167,
§
1 ;
77 Del. Laws, c. 199,
§
18 ;
78 Del. Laws, c. 44,
§§
36, 37 ;
83 Del. Laws, c. 433,
§
16 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2509 Examination.
(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. 24 Del. Laws, c. 140,
§
3 ;
Code 1915,
§
864;
35 Del. Laws, c. 56,
§
1 ;
Code 1935,
§
944;
41 Del. Laws, c. 87,
§
1 ;
42 Del. Laws, c. 91,
§
1 ;
46 Del. Laws, c. 95,
§
2 ;
24 Del. C. 1953,
§
2523;
53 Del. Laws, c. 90,
§
7 ;
58 Del. Laws, c. 511,
§
57 ;
59 Del. Laws, c. 318,
§
3 ;
64 Del. Laws, c. 167,
§
1 ;
68 Del. Laws, c. 206,
§
1 ;
75 Del. Laws, c. 436,
§
22 ;
76 Del. Laws, c. 167,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2510 Reciprocity or license transfer.
(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) 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) Has passed the NAPLEX or a comparable alternative national examination accepted by the Board.
(3) Has received a passing score on a jurisprudence examination as set forth in the Board’s rules and regulations.
(4) Has passed the examination of the Foreign Pharmacy Graduate Examination Committee (FPGEC) of the 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. The State Bureau of Identification is the intermediary for the purpose of this subsection and the Board, or its 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) A reciprocal applicant is not required to obtain the practical experience required under § 2508(a) of this title. 24 Del. Laws, c. 140,
§
3 ;
Code 1915,
§
864;
35 Del. Laws, c. 56,
§
1 ;
Code 1935,
§
944;
41 Del. Laws, c. 87,
§
1 ;
42 Del. Laws, c. 91,
§
1 ;
46 Del. Laws, c. 95,
§
2 ;
24 Del. C. 1953,
§
2523;
53 Del. Laws, c. 90,
§
7 ;
58 Del. Laws, c. 511,
§
57 ;
59 Del. Laws, c. 318,
§
3 ;
64 Del. Laws, c. 167,
§
1 ;
68 Del. Laws, c. 206,
§
1 ;
75 Del. Laws, c. 436,
§
23 ;
76 Del. Laws, c. 167,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 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. 24 Del. Laws, c. 140,
§§
9, 12 ;
24 Del. Laws, c. 141,
§§
1, 2 ;
Code 1915,
§§
858, 861, 868;
28 Del. Laws, c. 62 ;
29 Del. Laws, c. 55 ;
36 Del. Laws, c. 103,
§
1 ;
Code 1935,
§§
938, 941, 948;
43 Del. Laws, c. 95,
§
1 ;
45 Del. Laws, c. 90,
§
3 ;
46 Del. Laws, c. 95,
§
3 ;
24 Del. C. 1953,
§§
2503, 2506, 2507;
53 Del. Laws, c. 90,
§§
4, 272 ;
53 Del. Laws, c. 108,
§
27 ;
55 Del. Laws, c. 316,
§
3 ;
62 Del. Laws, c. 251,
§§
1, 4, 5 ;
64 Del. Laws, c. 452,
§
2 ;
65 Del. Laws, c. 378,
§
2 ;
68 Del. Laws, c. 206,
§
1 ;
74 Del. Laws, c. 262,
§
43 ;
76 Del. Laws, c. 167,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 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 and who pays the required fee.
(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.
(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 retaking and passing the Multistate Pharmacy Jurisprudence Exam (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 retake and pass the MPJE. 24 Del. Laws, c. 140,
§§
4, 6 ;
Code 1915,
§§
865, 867;
32 Del. Laws, c. 45,
§
1 ;
Code 1935,
§§
945, 947;
24 Del. C. 1953,
§§
2524, 2525;
49 Del. Laws, c. 263 ;
53 Del. Laws, c. 90,
§
8 ;
62 Del. Laws, c. 251,
§§
7-9 ;
64 Del. Laws, c. 247,
§
1 ;
68 Del. Laws, c. 206,
§
1 ;
70 Del. Laws, c. 186,
§
1 ;
76 Del. Laws, c. 167,
§
1 ;
79 Del. Laws, c. 193,
§
5 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2513 Temporary license [Effective June 30, 2026] [Repealed].
76 Del. Laws, c. 167,
§
1 ;
repealed by 85 Del. Laws, c. 49, § 1, effective June 30, 2026. ;
§ 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 this chapter, the Board shall request that the Attorney General issue a cease and desist order and take any other further appropriate action. 24 Del. Laws, c. 140,
§
16 ;
Code 1915,
§
872;
32 Del. Laws, c. 45,
§
2 ;
Code 1935,
§
952;
24 Del. C. 1953,
§
2529;
68 Del. Laws, c. 206,
§
1 ;
76 Del. Laws, c. 167,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2515 Grounds for discipline for individuals.
(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:
(1) Engaged in or knowingly cooperated in fraud or material deception in order to acquire a license to practice pharmacy, has impersonated another person holding a license, has allowed another person to use the pharmacist’s license, or has aided or abetted a person not licensed to practice pharmacy to be represented as a pharmacist.
(2) Illegally, incompetently, or negligently practiced pharmacy.
(3) Was convicted of a crime that is substantially related to the practice of pharmacy; a copy of the record of conviction certified by the clerk of the court entering the conviction is conclusive evidence of conviction.
(4) Has a current condition that impairs the pharmacist’s judgment or adversely affects the pharmacist’s ability to practice safely and in a competent, ethical, and professional manner.
(5) Engaged in an act of consumer fraud or deception, engaged in the restraint of competition, or participated in price-fixing activities.
(6) Violated a lawful provision of this chapter or any lawful regulation established hereunder.
(7) Had that pharmacist’s own license to practice pharmacy suspended or revoked or was subjected to other disciplinary action taken by the appropriate licensing authority in another jurisdiction; provided, however, that the underlying grounds for the suspension, revocation, or other action in another jurisdiction have been presented to the Board by certified record and the Board has determined that the facts found by the appropriate licensing authority in the other jurisdiction constitute 1 or more of the acts listed in this subsection. Every person licensed to practice pharmacy in this State consents to the release of information regarding license suspension or revocation or other disciplinary action by the Board of Pharmacy or by other comparable agencies in other jurisdictions and waives all objections to the admissibility of previously adjudicated evidence of the acts or offenses which underlie license suspension or revocation or other disciplinary action.
(8) Failed to notify the Board that the pharmacist’s license to practice pharmacy in another jurisdiction was subject to discipline, or was surrendered, suspended, or revoked; or that the licensee has been convicted of a crime that is substantially related to the practice of pharmacy. A certified copy of the record of disciplinary action, or of the surrender, suspension, or revocation of the license is conclusive evidence thereof. A copy of the record of conviction certified by the clerk of the court entering the conviction is conclusive evidence of conviction.
(9) Has a physical or mental impairment that prevents the pharmacist from engaging in the practice of pharmacy with reasonable skill, competence, and safety to the public.
(10) Violated the Board’s code of ethics as adopted in the Board’s rules and regulations.
(b) Subject to the provisions of this chapter and subchapter IV of Chapter 101 of Title 29, the Board may not discipline a license to practice pharmacy or limit a licensee’s right to engage in the practice of pharmacy until the Board gives to the licensee proper notice and opportunity to be heard. 24 Del. Laws, c. 140,
§
4 ;
Code 1915,
§
865;
32 Del. Laws, c. 45,
§
1 ;
Code 1935,
§
945;
24 Del. C. 1953,
§
2527;
53 Del. Laws, c. 90,
§
10 ;
53 Del. Laws, c. 267 ;
54 Del. Laws, c. 253 ;
55 Del. Laws, c. 316,
§
2 ;
59 Del. Laws, c. 318,
§
4 ;
62 Del. Laws, c. 251,
§
11 ;
65 Del. Laws, c. 355,
§
1 ;
65 Del. Laws, c. 378,
§
4 ;
68 Del. Laws, c. 206,
§
1 ;
70 Del. Laws, c. 186,
§
1 ;
74 Del. Laws, c. 262,
§§
44, 45 ;
75 Del. Laws, c. 436,
§§
24-26 ;
76 Del. Laws, c. 167,
§
1 ;
79 Del. Laws, c. 238,
§
1 ;
80 Del. Laws, c. 80,
§
13 ;
83 Del. Laws, c. 52,
§
14 ;
84 Del. Laws, c. 42,
§
1 ;
84 Del. Laws, c. 158,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2516 Disciplinary sanctions for individuals.
(a) The Board may impose any of the following sanctions, singly or in combination, when it determines that a person licensed to practice pharmacy has violated a ground for discipline set forth in § 2515 of this title:
(1) Issue a letter of reprimand.
(2) Place the licensee on probationary status and require the licensee to do any of the following:
a. Report regularly to the Board upon the matters that are the basis of the probation.
b. Limit all practice and professional activities to those areas prescribed by the Board.
(3) Suspend the license of the licensee.
(4) Permanently revoke the license of the licensee.
(5) Impose an administrative penalty, not to exceed $10,000 for a first-time violation. Any subsequent violations may be subject to an administrative penalty, not to exceed $50,000 for each such violation.
(b) The Board may withdraw or reduce conditions of probation imposed under paragraph (a)(2) of this section if it finds that the deficiencies that required the conditions of probation to be imposed have been remedied.
(c) If the Board suspends a license to practice pharmacy due to an impairment of the licensee, the Board may reinstate the license if, after a hearing, the Board is satisfied that the licensee is able to practice pharmacy with reasonable skill, competence, and safety to the public. 24 Del. C. 1953,
§
2531;
53 Del. Laws, c. 90,
§§
12-16 ;
62 Del. Laws, c. 251,
§
12 ;
63 Del. Laws, c. 234,
§
1 ;
68 Del. Laws, c. 206,
§
1 ;
76 Del. Laws, c. 167,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2517 Hearing procedures.
(a) If a complaint alleging a violation of § 2515 of this title is filed with the Board under § 8735(h) of Title 29, the hearing must be noticed and conducted in accordance with the Administrative Procedures Act, Chapter 101 of Title 29.
(b) If a licensee is in disagreement with the decision of the Board, the licensee may appeal the Board’s decision to the Superior Court within 30 days of the date the copy of the decision is mailed to that licensee. Upon appeal, the Court shall hear the evidence on the record. A stay pending review may be granted by the Court in accordance with § 10144 of Title 29. 24 Del. Laws, c. 140,
§
4 ;
32 Del. Laws, c. 45,
§
1 ;
34 Del. Laws, c. 71 ;
Code 1915,
§
874A;
Code 1935,
§§
945, 955, 956E;
41 Del. Laws, c. 87,
§
6 ;
46 Del. Laws, c. 143,
§
1 ;
24 Del. C. 1953,
§§
2527, 2586;
49 Del. Laws, c. 220,
§
27 ;
53 Del. Laws, c. 267 ;
54 Del. Laws, c. 253 ;
55 Del. Laws, c. 316,
§
2 ;
59 Del. Laws, c. 318,
§§
4, 9 ;
62 Del. Laws, c. 251,
§
11 ;
65 Del. Laws, c. 355,
§
1 ;
65 Del. Laws, c. 378,
§
4 ;
68 Del. Laws, c. 206,
§
1 ;
69 Del. Laws, c. 423,
§
23 ;
70 Del. Laws, c. 186,
§
1 ;
74 Del. Laws, c. 262,
§§
44, 45 ;
75 Del. Laws, c. 436,
§§
24-26 ;
76 Del. Laws, c. 167,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2518 Reinstatement of a suspended license; removal from probationary status [Effective June 30, 2026] [Repealed].
76 Del. Laws, c. 167,
§
1 ;
70 Del. Laws, c. 186,
§
1 ;
repealed by 85 Del. Laws, c. 49, § 1, effective June 30, 2026. ;
§ 2519 Temporary suspension pending hearing.
In the event of a formal or informal complaint concerning the activity of a licensee that presents a clear and immediate danger to the public health, safety or welfare, the Board may temporarily suspend the person’s license, pending a hearing, upon the written order of the Secretary of State or the Secretary’s designee, with the concurrence of the Board chair or the Board chair’s designee. An order temporarily suspending a license may not be issued unless the person or the person’s attorney received at least 24 hours’ written or oral notice before the temporary suspension so that the person or the person’s attorney may file a written response to the proposed suspension. The decision as to whether to issue the temporary order of suspension will be decided on the written submissions. An order of temporary suspension pending a hearing may remain in effect for no longer than 60 days from the date of the issuance of the order unless the temporarily suspended person requests a continuance of the hearing date. If the temporarily suspended person requests a continuance, the order of temporary suspension remains in effect until the hearing is convened and a decision is rendered by the Board. A person whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Board shall schedule the hearing on an expedited basis, provided that the Board receives the request within 5 calendar days from the date on which the person received notification of the decision to temporarily suspend the person’s license. 68 Del. Laws, c. 206,
§
1 ;
76 Del. Laws, c. 167,
§
1 ;
79 Del. Laws, c. 213,
§
2 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2520 Counseling of pharmacists [Effective June 30, 2026] [Repealed].
71 Del. Laws, c. 101,
§
1 ;
70 Del. Law, c. 186,,
§
1;
76 Del. Laws, c. 167,
§
1 ;
repealed by 85 Del. Laws, c. 49, § 1, effective June 30, 2026. ;
§ 2521 Impaired pharmacist [Effective June 30, 2026] [Repealed].
68 Del. Laws, c. 206,
§
1 ;
70 Del. Laws, c. 186,
§
1 ;
76 Del. Laws, c. 167,
§
1 ;
repealed by 85 Del. Laws, c. 49, § 1, effective June 30, 2026. ;
Delaware General Assembly
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§ 2522 Prescription labeling.
(a) A practitioner prescribing a drug to be prepared and dispensed by a pharmacist in this State for the use of a patient or any third person must, as part of the prescription, include directions describing the exact method by which the drug must be taken or administered. A prescription without specific directions, or a prescription bearing the notation “as directed” without specific directions, may not be prepared or dispensed.
(b) A pharmacist must ensure that a label is affixed to every container in which a drug is dispensed. The label must contain the information required by the Board’s rules and regulations.
(c) Practitioners who sell or dispense drugs directly to patients must label all drugs or provide a document that includes all of the following information:
(1) The patient’s full name and address.
(2) The date the drugs were dispensed to the patient.
(3) The practitioner’s name, office phone number, and address.
(4) The practitioner’s Drug Enforcement Administration number in the case of a controlled substance.
(5) Name, strength, dosage form, and quantity (or stop date) of drug and route of administration if other than oral form of drug is prescribed.
(6) Renewals authorized.
(7) The practitioner’s directions.
(d) No pharmacist may fail to dispense a prescription because it is not clearly written or lacks information required by this title without first making a reasonable effort to contact the practitioner who issued the prescription to gather the clear and complete information. 24 Del. C. 1953,
§
2563;
58 Del. Laws, c. 244,
§
2 ;
68 Del. Laws, c. 206,
§
1 ;
75 Del. Laws, c. 101,
§
1 ;
75 Del. Laws, c. 415,
§§
1, 2 ;
76 Del. Laws, c. 167,
§
1 ;
85 Del. Laws, c. 49,
§
1 ;
§ 2523 Exemptions.
Nothing in this chapter may be construed to prevent any of the following:
(1) A student or graduate of an accredited school of pharmacy from receiving practical training pursuant to an internship or other approved program under the supervision of a pharmacist in this State.
(2) 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, from performing the functions permitted under the rules and regulations of the Board and not inconsistent with this chapter.
(3) A pharmacy technician or certified pharmacy technician from performing under the direct supervision of a pharmacist the delegated functions permitted under the rules and regulations of the Board and not inconsistent with this chapter.
(4) A practitioner licensed under the laws of this State to practice within the scope of that practitioner’s license.
(5) The selling at retail of over-the-counter products.
(6) A business not licensed as a pharmacy to sell gases that are used for medicinal purposes and which require a prescription, provided that:
a. The business is registered with the Board.
b. The sale is authorized by a written, electronic, or fax order or by a verbal order reduced to writing from a licensed practitioner.
c. The record of the written, electronic, or fax order, or the verbal order reduced to writing is maintained on the premises of the business for at least 3 years.
d. The gas product is stored and dispensed according to requirements established by the Board.
(7) The sale of noncontrolled prescription drugs designated for veterinary use by a business not licensed as a pharmacy, provided that the business is registered with the Board and the sale is authorized by a written, electronic, or fax order or by a verbal order reduced to writing from a licensed veterinarian.
(8) Pharmacist selection of appropriate dosage forms, concentrations, equivalent strengths or routes of administration of medications.
(9) a. A practitioner from dispensing the unused portion of practitioner-dispensed topical medication to the patient upon discharge or the conclusion of the visit if the practitioner-dispensed topical medication is labeled consistent with the requirements under § 2522 of this title and required for continuing treatment. If the practitioner-dispensed topical medication is used in an operating room or emergency department, the practitioner must counsel the patient on the proper use and administration of the drug.
b. A practitioner who fails to comply with paragraph (9)a. of this section is subject to disciplinary sanction under this title.
(10) [Repealed.]
(11) A manufacturer or wholesaler from providing distribution of dialysate drugs or devices necessary to perform home dialysis on patients with end-stage renal disease, provided that all of the following criteria are met:
a. The dialysate drugs or devices are approved by the U.S. Food and Drug Administration as required by federal law.
b. The dialysate drugs or devices are lawfully held by a manufacturer or a manufacturer’s agent that is properly registered with the Board as a manufacturer or wholesaler.
c. The dialysate drugs or devices are held and delivered in their original, sealed label packaging from the manufacturing facility.
d. The dialysate drugs or devices are delivered only by the manufacturer or the manufacturer’s agent and only upon receipt of a prescription from a practitioner.
e. The manufacturer or the manufacturer’s agent delivers the dialysate drugs or devices directly to 1 of the following:
1. A patient with end stage renal disease or the patient’s designee for the patient’s self-administration of dialysis therapy.
2. A health-care provider or institution for administration or delivery of the dialysis therapy to a patient with end stage renal disease. 24 Del. Laws, c. 140,
§
1 ;
Code 1915,
§
862;
Code 1935,
§
942;
24 Del. C. 1953,
§
2521;
64 Del. Laws, c. 452,
§
1 ;
68 Del. Laws, c. 206,
§
1 ;
70 Del. Laws, c. 186,
§
1 ;
75 Del. Laws, c. 161,
§
9 ;
75 Del. Laws, c. 260,
§§
1, 2 ;
76 Del. Laws, c. 167,
§
1 ;
84 Del. Laws, c. 158,
§
2 ;
85 Del. Laws, c. 49,
§
2 ;
85 Del. Laws, c. 49,
§
1 ;
85 Del. Laws, c. 97,
§
1 ;
§ 2524 Miscellaneous fees [Effective June 30, 2026] [Repealed].
24 Del. Laws, c. 140,
§§
9, 12 ;
24 Del. Laws, c. 141,
§§
1, 2 ;
Code 1915,
§§
858, 861, 868;
28 Del. Laws, c. 62 ;
29 Del. Laws, c. 55 ;
36 Del. Laws, c. 103,
§
1 ;
Code 1935,
§§
938, 941, 948;
43 Del. Laws, c. 95,
§
1 ;
45 Del. Laws, c. 90,
§
3 ;
46 Del. Laws, c. 95,
§
3 ;
24 Del. C. 1953,
§§
2503, 2506, 2507;
53 Del. Laws, c. 90,
§§
4, 272 ;
53 Del. Laws, c. 108,
§
27 ;
55 Del. Laws, c. 316,
§
3 ;
62 Del. Laws, c. 251,
§§
1, 4, 5 ;
64 Del.
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