2006 Delaware Code - Subchapter I — General Provisions; Board of Pharmacy

§ 2501. Legislative findings and intent; construction of chapter.

The practice of pharmacy in the State is declared a learned professional practice affecting the public health, safety and welfare and is subject to regulation and control in the public interest. It is further declared to be a matter of public interest and concern that the practice of pharmacy, as defined in this chapter, merit and receive the confidence of the public and that only qualified persons be permitted to engage in the practice of pharmacy in the State. This chapter shall be liberally construed to carry out these objects and purposes.

It is the purpose of this chapter to promote, preserve and protect the public health, safety and welfare by and through the effective control and regulation of the practice of pharmacy and of the registration of drug outlets engaged in the manufacture, production, sale and distribution of drugs, medications and such other materials as may be used in the diagnosis and treatment of injury, and prevention of illness and disease. (68 Del. Laws, c. 206, § 1.)

§ 2502. Definitions as used in this chapter.

(a) "Approved Prescription Drug Products with Therapeutic Equivalent Evaluations" means a text containing a list of prescription drug products by generic name prepared from time to time by the Food and Drug Administration which contains therapeutic evaluations.

(b) "Board," "Board of Pharmacy," or "State Board of Pharmacy" as used in this chapter means Delaware State Board of Pharmacy.

(c) "Dispense" or "dispensing" means the preparation and delivery of a prescription drug pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration or use by a patient or other individual entitled to receive the prescription drug.

(d) "Drug" means:

(1) Substances recognized as drugs in the Official United States Pharmacopoeia/National Formulary or any supplement to any of them;

(2) Substances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals;

(3) Substances (other than food) intended to affect the structure or any function of the body of humans or animals;

(4) Substances intended for use as a component of any article specified in clause (i), (ii) or (iii) of this subsection.

It does not include devices or their components, parts or accessories.

(e) "Drug outlets" mean pharmacies, in-state or out-of-state wholesalers, manufacturers and nonpharmacy veterinary outlets.

(f) "Intern" means a person registered by the Board and supervised by an approved preceptor, who is completing practical experience requirements of the Board prior to licensure.

(g) "Internship/externship" means a period of practical experience established by Board regulation that must be completed by applicants applying for licensure in the State.

(h) "Manufacturer" means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling of a drug, excluding the dispensing of a drug pursuant to a prescription.

(i) "Over-the-counter medication," "OTC," means medicines or drugs which may be sold without a prescription and which are packaged for use by the consumer and labeled in accordance with the requirements of the statutes and regulations of this State and the federal government.

(j) "Pharmacist" means an individual licensed by this State to engage in the practice of pharmacy in compliance with applicable federal and state statutes and regulations.

(k) "Pharmacist-in-charge" means a person licensed by the State to engage in the practice of pharmacy; who has overall responsibility for compliance with statutes and regulations that apply to the operation of a pharmacy.

(l) "Pharmacy" means an establishment licensed as such by the Board where pharmacy may be practiced.

(m) "Practice of pharmacy" means the interpretation and evaluation of an authorized prescriber's order. This process shall include, but not be limited to, the proper compounding, dispensing, labeling, packaging and administering of a drug to the patient or the patient's agent. The practice shall include the application of the pharmacist's knowledge of pharmaceutics, pharmacology, pharmacokinetics, drug and food interactions, drug product selection and patient counselling. It shall also include:

(1) Maintenance of proper records.

(2) Proper safe storage of drugs.

(3) Participation in drug utilization and/or drug regimen review.

(4) Participation in therapeutic drug selection and substitution of therapeutically equivalent drug products.

(5) Advisor to the practitioner as well as to the patient regarding the total scope of drug therapy, so as to deliver the best care possible.

(6) The ability of a pharmacist to recommend over-the-counter products.

(7) Monitoring drug therapy to determine if there is any potential problem with doses, combinations of medications ordered or noncompliance with the prescriber's orders.

(8) The teaching of pharmacy, the practice in an industrial setting which is directly related to the practice of pharmacy and the activities of licensed pharmacists who are involved with administrative duties, which are directly related to the practice of pharmacy.

(9) A pharmacist may administer injectable medications, biologicals and adult immunizations pursuant to a valid prescription or physician-approved protocol. The scope of the protocol or valid prescription must be limited to that physician's patient population. A Pharmacy Regulatory Council of the Board of Medical Practice shall establish requirements and regulations that pharmacists must meet in order to administer injectable adult immunizations, biologicals and medications. Those regulations shall include a list of those classes of and the indications for the biologicals, medications and adult immunizations that are appropriate to be administered by pharmacists who have been so authorized. The Pharmacy Regulatory Council shall consist of 7 members as follows:

a. The Board of Pharmacy shall appoint 1 public member and 4 pharmacists.

b. The Board of Medical Practice shall appoint 2 physicians, 1 of whom shall serve as Chair of the Pharmacy Regulatory Council.

(10) A pharmacist may perform capillary blood tests and interpret the results as a means to screen for or monitor disease risk factors and facilitate patient education. The pharmacist shall report results obtained from such blood tests to the patient's health care practitioner. Pharmacists must comply with all state and federal laboratory regulations.

(n) "Practitioner" means any person who is authorized by law to prescribe drugs in the course of professional practice or research in this State.

(o) "Preceptor" means a registered pharmacist approved by the Board who supervises an intern.

(p) "Prescription drug" or "legend drug" means any 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)].

(q) "Prescription drug order" means a lawful written or verbal order of a practitioner for a drug.

(r) "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.

(s) "Therapeutically equivalent" means drugs which contain the same active ingredient(s) and are identical in strength or concentration, dosage form and route of administration which are classified as being therapeutically equivalent in the latest edition or supplement of the F.D.A.'s Approved Drug Product List.

(t) "Wholesale distribution" and "wholesale distributions" means distribution of drugs to persons other than a consumer or patient, but does not include:

(1) The purchase or other acquisition by a hospital or other health care entity which is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or health care entities which are members of such organizations;

(2) The sale, purchase or trade of a drug or an offer to sell, purchase or trade a drug 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 organization to the extent otherwise permitted by law;

(3) The sale, purchase or trade of a drug or an offer to sell, purchase or trade a drug among hospitals or other health care entities which are under common control;

(4) The sale, purchase or trade of a drug or an offer to sell, purchase or trade a drug for emergency medical reasons;

(5) The sale, purchase or trade of a drug, an offer to sell, purchase or trade a drug, or the dispensing of a drug pursuant to a prescription; or

(6) A transfer of prescription drugs by a pharmacy to another pharmacy to alleviate a temporary shortage.

(u) "Wholesaler distributor" means anyone engaged in wholesale distribution of drugs, including, but not limited to, manufacturers' and distributors' warehouses, chain drug warehouses and wholesale drug warehouses; independent wholesale drug traders and pharmacies that conduct wholesale distributions. (68 Del. Laws, c. 206, § 1; 70 Del. Laws, c. 186, § 1; 71 Del. Laws, c. 412, § 1; 74 Del. Laws, c. 262, § 42.)

§ 2503. State Board of Pharmacy; appointment.

(a) The State Board of Pharmacy, heretofore established and hereinafter in this chapter referred to as the "Board," shall consist of 9 persons who shall be appointed by the Governor for terms of 3 years from July 1 in the year of appointment.

(1)a. Five of the 9 persons appointed shall be:

(A) Graduates of a school or college of pharmacy accredited by the American Council on Pharmaceutical Education at the time of graduation; and

(B) Licensed as pharmacists in this State; and

(C) Residents of this State and actively engaged in the practice of pharmacy in this State; and

(D) Have 5 years of experience in the practice of pharmacy in this State after licensure.

2. Three of the 5 shall reside in New Castle County, 1 in Kent County and 1 in Sussex County.

b. The Governor shall appoint a committee of 6 persons who are residents of the State, at least 3 members of the committee will be pharmacists licensed in Delaware. That Committee will review the nominations and make recommendations to the Governor. Such nominations shall be recommendations only and shall not be binding in any manner upon the Governor.

(2) Four of the 9 persons shall be appointed by the Governor and shall be known as the "public members." Said public members shall be residents of this State who have attained the age of majority and shall not be, nor ever have been, a member of the profession of pharmacy, or a person who has ever had any material financial interest in the providing of pharmacy service, nor shall they have been related to someone engaged in the practice of pharmacy, nor shall they be engaged in any activity directly related to the practice of pharmacy.

(b) Vacancies occurring for any reason other than the expiration of term shall be filled by the Governor for the remainder of the unexpired term.

(c) Before entering upon the discharge of their official duties, the members of the Board shall take and subscribe the oath as provided in Article XIV of the Delaware Constitution. (24 Del. Laws, c. 140, § 7; Code 1915, § 856; Code 1935, § 936; 24 Del. C. 1953, § 2501; 53 Del. Laws, c. 90, § 1; 59 Del. Laws, c. 318, § 1; 60 Del. Laws, c. 586, §§ 1, 2; 65 Del. Laws, c. 378, § 1; 67 Del. Laws, c. 366, § 7; 67 Del. Laws, c. 368, § 13; 68 Del. Laws, c. 206, § 1.)

§ 2504. Terms of office.

(a) Except as provided in subsection (b) of this section, members of the Board of Pharmacy shall be appointed for a term of 3 years beginning July 1 in the year of appointment, except that members of the Board who are appointed to fill vacancies which occur prior to the expiration of a former member's full term shall serve the unexpired portion of such term.

(b)(1) The terms of the members of the Board shall be staggered, so that the terms of no more than 3 members shall expire in any year.

(2) Members of the Board on February 11, 1992, shall serve the balance of their terms.

(c) A person who has never served on the Board may be appointed to the Board 2 consecutive times, but no such person shall thereafter be eligible for 2 consecutive appointments. No person who has been twice appointed to the Board, or who has served on the Board for 6 years within any 9-year period, shall again be appointed to the Board until an interim period of at least 1 term has expired since such person last served.

(d) Any act or vote by a person appointed in violation of subsection (c) of this section shall be invalid. An amendment or revision of this chapter is not sufficient cause for any appointment or attempted appointment in violation of subsection (c) of this section, unless such amendment or revision amends this section to permit such appointment. (24 Del. Laws, c. 140, § 7; Code 1915, § 856; Code 1935, § 936; 24 Del. C. 1953, § 2501; 53 Del. Laws, c. 90, § 1; 59 Del. Laws, c. 318, § 1; 60 Del. Laws, c. 586, §§ 1, 2; 65 Del. Laws, c. 378, § 1; 67 Del. Laws, c. 366, § 7; 67 Del. Laws, c. 368, § 13; 68 Del. Laws, c. 206, § 1.)

§ 2505. Removal of Board members.

The Governor may remove a member of the Board for cause for 1 or more of, but not limited to, the following grounds:

(1) The refusal or inability for any reason of a Board member to perform duties as a member of the Board in an efficient, responsible and professional manner;

(2) The misuse of office by a member of the Board, whether or not to obtain personal pecuniary or material gain or advantage personally or for another through such office;

(3) The violation of this chapter or any of the rules and regulations adopted hereunder;

(4) Misconduct or incompetencies in the performance of duties. (24 Del. Laws, c. 140, § 7; Code 1915, § 856; Code 1935, § 936; 24 Del. C. 1953, § 2501; 53 Del. Laws, c. 90, § 1; 59 Del. Laws, c. 318, § 1; 60 Del. Laws, c. 586, §§ 1, 2; 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.)

§ 2506. Organization.

(a) Officers. -- The Board shall elect from its members a President and such other officers as it deems appropriate and necessary to the conduct of its business. The President of the Board shall preside at all meetings of the Board and shall be responsible for the performance of all of the duties and functions of the Board required or permitted by this chapter. Each additional officer elected by the Board shall perform those duties normally associated with the position and such other duties assigned to the officer from time to time by the Board.

(b) Terms of office. -- Officers elected by the Board shall serve terms of 1 year commencing with the day of their election, and ending upon election of their successors.

(c) Executive Secretary. -- The Board shall elect annually, a licensed pharmacist who shall be an ex-officio member of the Board without vote to serve as Executive Secretary. The Executive Secretary shall be responsible for the performance of the regular administrative functions of the Board and such other duties as the Board may direct. (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.)

§ 2507. Compensation.

The members of the Board shall receive the sum of at least $50 for each day, or fraction of a day, actually employed in the discharge of their official duties and their necessary expenses while engaged therein. Each member may not receive more than $500 each year in salary. (24 Del. Laws, c. 140, § 10; Code 1915, § 859; 36 Del. Laws, c. 103, § 1; Code 1935, § 939; 45 Del. Laws, c. 90, § 2; 24 Del. C. 1953, § 2505; 53 Del. Laws, c. 90, § 3; 62 Del. Laws, c. 251, §§ 2, 3; 68 Del. Laws, c. 206, § 1.)

§ 2508. Meetings.

(a) Number. -- The Board shall meet at least 6 times a year to transact its business. One such meeting held during each fiscal year of the State shall be designated as the annual meeting and shall be for the purpose of electing officers and for the reorganization of the Board. The Board shall meet at such additional times as it may determine. Such additional meetings may be called by the President of the Board, or by two thirds of the members of the Board.

(b) Place. -- The Board shall meet at such place as it may from time to time determine. The place for each meeting shall be determined prior to giving notice of such meeting.

(c) Notice. -- Notice of all meetings of the Board shall be given in a manner and pursuant to requirements prescribed by law.

(d) Quorum. -- A majority of the members of the Board shall constitute a quorum for the conduct of a Board meeting and, except where a greater number is required by this chapter, or by any rule or regulation of the Board, all actions of the Board shall be by a majority of a quorum.

(e) Open meetings. -- All Board meetings and hearings shall be open to the public in accordance with the law. (24 Del. Laws, c. 140, §§ 8, 9; Code 1915, §§ 857, 858; Code 1935, §§ 937, 938; 45 Del. Laws, c. 90, § 1; 24 Del. C. 1953, §§ 2502, 2503; 53 Del. Laws, c. 90, § 272; 59 Del. Laws, c. 318, § 2; 62 Del. Laws, c. 251, § 1; 68 Del. Laws, c. 206, § 1.)

§ 2509. Rules and regulations.

The Board shall make, adopt, amend and repeal such rules and regulations as may be deemed necessary by the Board, from time to time, for the proper administration and enforcement of this chapter. Such rules and regulations shall be promulgated in accordance with the procedures specified in the Administrative Procedures Act of this State. All rules and regulations adopted prior to February 11, 1992, shall remain valid as if enacted pursuant to this section unless inconsistent with this chapter. (68 Del. Laws, c. 206, § 1.)

§ 2510. Licensure responsibility.

The Board shall be responsible for the control and regulation of the practice of pharmacy in this State including, but not limited to, the following:

(1) The licensing by examination or by reciprocity of applicants who are qualified to engage in the practice of pharmacy under this chapter;

(2) The renewal of licenses to engage in the practice of pharmacy;

(3) The determination and issuance of standards for recognition and approval of degree programs of schools and colleges of pharmacy whose graduates shall be eligible for licensure in this State, and the specification and enforcement of requirements for practical training, including internship. (68 Del. Laws, c. 206, § 1.)

§ 2511. Medications, drugs and other materials.

(a) The Board shall also have the following responsibilities in regard to medications, drugs and other materials used in this State in the diagnosis, mitigation and treatment or prevention of injury, illness and disease:

(1) The regulation of the sale and the dispensing of medications, drugs and other materials including the right to seize any such drugs and other materials found to be detrimental to the public health and welfare by the Board in accordance with Chapter 33 of Title 16;

(2) The specifications of minimum professional and technical equipment, environment, supplies and procedures for the compounding and/or dispensing of such medications, drugs and other materials within the practice of pharmacy;

(3) The control of the purity and quality of such medications, drugs and other materials within the practice of pharmacy;

(4) The issuance and renewal of certificates of registration of drug outlets for purposes of ascertaining those persons engaged in the manufacture and distribution of drugs.

(5) Nothing contained in this chapter or in § 3315 of Title 16 shall prohibit a pharmacist licensed in this State from dispensing a valid non-controlled prescription received via electronic transmission from a practitioner's office to the prescription department.

(b) The Board shall enforce the provisions of, and promulgate rules and regulations to carry out, the law relating to pure drugs, as provided by § 3315 of Title 16. (Code 1915, § 875; Code 1935, § 956; 24 Del. C. 1953, § 2509; 68 Del. Laws, c. 206, § 1; 72 Del. Laws, c. 159, § 1.)

§ 2512. Other duties, powers and authority.

(a) The Board shall have such other duties, powers and authority as may be necessary to the enforcement of this chapter and to the enforcement of Board rules and regulations made pursuant thereto, which shall include, but are not limited to, the following:

(1) The Board may join such professional organizations and associations organized exclusively to promote the improvement of the standards of the practice of pharmacy for the protection of the health and welfare of the public and whose activities assist and facilitate the work of the Board and may pay such amount as is necessary for the annual dues.

(2) The Executive Secretary of the Board shall keep the seal of the Board and shall affix it only in such manner as may be prescribed by the Board.

(3) The legal services will be provided by the Department of Justice pursuant to Chapter 25 of Title 29.

(4) The Board shall submit a written report to the Governor and to the Delaware Pharmaceutical Society within 3 months after the conclusion of the fiscal year.

(5) The President and Secretary may administer oaths in all matters before the Board.

(6) The Board may 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. Persons who have been subpoenaed may be required to testify in any and all matters within the jurisdiction of the Board. Subpoenas shall be issued by the President or the Executive Secretary of the Board and enforceable by the Superior Court.

(7) All persons who are qualified under this chapter shall be entitled to a renewal biennially by submitting the fee required as well as showing evidence of compliance with the continuing education requirements established by the Board if applicable. Registrants who do not pay the fee by the date due shall be assessed an additional $10. The amount to be charged for each fee imposed under this chapter shall approximate and reasonably reflect all costs necessary to defray the expenses of the Board as well as the proportional expenses incurred by the Division of Professional Regulation in its service on behalf of the Board. There shall be a separate fee charged for each service or activity, but no fee shall be charged for a purpose not specified in this chapter. The application fee shall not be combined with any other fee or charge. At the beginning of each calendar year, the Division of Professional Regulation, or any other state agency acting in its behalf, shall compute, for each separate service or activity, the appropriate Board fees for the coming year.

(8)a. The Board may receive and expend funds from parties other than the State, provided:

1. Such funds are awarded for the pursuit of a specific objective which the Board is authorized to accomplish by this chapter, or which the Board is qualified to accomplish by reason of its jurisdiction or professional expertise;

2. Such funds are expended for the pursuit of the objective for which they are awarded;

3. Activities connected with or occasioned by the expenditures of such funds do not interfere with or impair the performance of the Board's duties and responsibilities and do not conflict with the exercise of the Board's powers as specified by this chapter;

4. Such funds are kept in a separate, special state account; and

5. Periodic reports are made to the Governor concerning the Board's receipt and expenditure of such funds.

b. The Board has the power to contract for the specific objective of the grant.

(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; 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.)