Drug Outlets

V.S.A. tit. 26, ch. 36, subch. 5

in effect

26 V.S.A. § 2061 Registration and licensure

2061. Registration and licensure (a) All drug outlets shall biennially register with the Board of Pharmacy. (b) Each drug outlet shall apply for a license in one or more of the following classifications: (1) Retail. (2) Institutional. (3) Manufacturer. (4) Wholesale distributor. (5) Investigative and research projects. (6) Compounding. (7) Outsourcing. (8) Home infusion. (9) Nuclear. (10) Third-party logistics provider. (c) No individual who is employed by a corporation that is licensed under any classification listed in subsection (b) of this section need obtain a license under the provisions of this subchapter. (d) The Board shall establish by rule under the powers granted to it under section 2032 of this title and 3 V.S.A. chapter 25, the criteria that each drug outlet that has employees or personnel engaged in the practice of pharmacy must meet to qualify for licensure in each classification designated in subsection (b) of this section. The Board may issue various types of licenses with varying restrictions to such outlets referred to in this subsection where the Board deems it necessary by reason of the type drug outlet requesting a license. (e) Retail and institutional drug outlets shall be managed by licensed pharmacists who have held an unrestricted license in this or another state for at least one year. The Board may grant a pharmacy permission to appoint a licensed pharmacist to manage the pharmacy who has been licensed for less than a year, subject to rules adopted by the Board. A pharmacist who holds a restricted license may petition the Board for permission to be a pharmacist manager, which may be granted by the Board for good cause shown. (f) Any nonpublic corporation owning a retail or institutional drug outlet, upon application, shall declare all owners of five percent or more of the stock of the corporation. (g) Any nonpharmacist owner of a retail or institutional drug outlet may be denied the right to own another pharmacy for a period to be determined by the Board, if he or she is found to be in violation of any of the grounds listed under 3 V.S.A. § 129a. (h) Each individual licensee and each business licensed under this chapter shall provide to the Office of Professional Regulation a working, readily accessible email address permitting communication with the Office. Added 1977, No. 266 (Adj. Sess.), § 1; amended 1981, No. 244 (Adj. Sess.), § 12; 1991, No. 240 (Adj. Sess.), § 3; 2005, No. 27, § 52; 2017, No. 48, § 13; 2017, No. 144 (Adj. Sess.), § 20; 2019, No. 30, § 14; 2019, No. 178 (Adj. Sess.), § 11, eff. Oct. 1, 2020; 2023, No. 77, § 13, eff. June 20, 2023.

26 V.S.A. § 2062 Application

2062. Application (a) The Board shall specify by rule the procedures to be followed for licensure. (b) Applications for licenses shall include the following information about the proposed drug outlet: (1) ownership; (2) location; (3) identity of pharmacist licensed to practice in the State, who shall be the pharmacist in charge of the drug outlet, in a retail or institutional drug outlet and such further information as the Board may deem necessary. (c) Licenses issued by the Board pursuant to this chapter shall not be transferable or assignable. (d) The Board shall specify by rule minimum standards for the professional responsibility in the conduct of any drug outlet that has employees or personnel engaged in the practice of pharmacy. The Board is specifically authorized to require that the portion of the facility to which such license applies be operated only under the direct supervision of no less than one pharmacist licensed to practice in this State and not otherwise, and to provide such other special requirements as deemed necessary. Added 1977, No. 266 (Adj. Sess.), § 1; amended 1981, No. 244 (Adj. Sess.), § 13.

26 V.S.A. § 2063 Notifications

2063. Notifications (a) All licensed drug outlets shall report to the Board of Pharmacy within 48 hours the occurrence of any of the following changes: (1) permanent closing; (2) change of ownership, management, location, or pharmacist manager; or (3) any and all other matters and occurrences as the Board may properly require by rule. (b) Disasters, thefts, accidents, and emergencies that may affect the strength, purity, or labeling of drugs, medications, legend devices, or other materials used in the diagnosis or the treatment of injury, illness, and disease shall be immediately reported to the Board. Added 1977, No. 266 (Adj. Sess.), § 1; amended 1981, No. 244 (Adj. Sess.), § 14; 2009, No. 35, § 35; 2013, No. 27, § 25; 2019, No. 178 (Adj. Sess.), § 11, eff. Oct. 1, 2020.

26 V.S.A. § 2064 Violations and penalties

2064. Violations and penalties (a) A drug outlet designated in section 2061 of this subchapter shall not be operated until a license has been issued to that outlet by the Board. (b) Unauthorized operation of a drug outlet may be penalized as provided in 3 V.S.A. § 127 and shall constitute unprofessional conduct by the licensees involved. Added 1977, No. 266 (Adj. Sess.), § 1; amended 1981, No. 244 (Adj. Sess.), § 15; 2017, No. 144 (Adj. Sess.), § 20.

26 V.S.A. § 2067 Wholesale distributors and manufacturers; licensure required

2067. Wholesale distributors and manufacturers; licensure required (a) A person who is not licensed under this subchapter shall not engage in wholesale distribution or manufacturing in this State. (b) [Repealed.] (c) The Board may require a separate license for each facility directly or indirectly owned or operated by the same business entity, or for a parent entity with divisions, subsidiaries, or affiliate companies when operations are conducted at more than one location and there exists joint ownership and control among all the entities. (d) An agent or employee of any licensed wholesale distributor or manufacturer shall not be required to obtain a license under this subchapter and may lawfully possess pharmaceutical drugs when that agent or employee is acting in the usual course of business or employment. Added 1991, No. 240 (Adj. Sess.), § 2; amended 2013, No. 27, § 26; 2017, No. 144 (Adj. Sess.), § 20; 2019, No. 30, § 14.

26 V.S.A. § 2068 Requirements; applicants; licenses

2068. Requirements; applicants; licenses An applicant shall satisfy the Board that it has, and licensees shall maintain, the following: (1) Acceptable storage and handling conditions plus facilities standards. (2) Minimum liability and other insurance as may be required under any applicable federal or State law. (3) A security system that includes after hours, central alarm or comparable entry detection capability, restricted premises access, adequate outside perimeter lighting, comprehensive employment applicant screening, and safeguards against employee theft. (4) An electronic, manual, or any other reasonable system of records, describing activities governed by this subchapter for the two-year period following disposition of each product, which shall be reasonably accessible, as defined by the Board by rule, during any inspection authorized by the Board. (5) Officers, directors, managers, and other persons in charge of wholesale drug distribution, manufacture, storage, and handling, who shall at all times demonstrate and maintain their capability to conduct business according to sound financial practices as well as State and federal law. (6) Complete, updated information about the applicant or licensee, which shall be provided to the Board. The information shall include all pertinent ownership and other key personnel and facilities information deemed necessary, by the Board, for enforcement of this subchapter. Any changes in such information shall be submitted at the time of license renewal or within 12 months from the date of such change, whichever occurs first. (7) Written policies and procedures that assure reasonable wholesale distributor preparation for, protection against, and handling of any facility security or operation problems, including those caused by natural disaster or government emergency, inventory inaccuracies or product shipping and receiving, outdated product or other unauthorized product control, appropriate disposition of returned goods, and product recalls. (8) Sufficient inspection procedures for all incoming and outgoing product shipments. (9) Operations in compliance with all federal requirements. (10)(A) Compliance with standards and procedures that the Board shall adopt by rule concerning provisions for initial and periodic on-site inspections, criminal and financial background checks, ongoing monitoring, reciprocity for out-of-state entities inspected by a third party organization recognized by the Board or inspected and licensed by a State licensing authority with legal standards for licensure that are comparable to the standards adopted by the Board pursuant to this subdivision (10), protection of proprietary information, and any other requirements consistent with the purposes of this subdivision (10). (B) The Board rules may recognize third party accreditation in satisfaction of some or all of the requirements of this subdivision (10). Added 1991, No. 240 (Adj. Sess.), § 2; amended 2005, No. 139 (Adj. Sess.), § 4; 2019, No. 30, § 14.

26 V.S.A. § 2069 Denials based on public interest

2069. Denials based on public interest The Board shall grant licensure to an applicant who satisfies the requirements of section 2061 of this title unless the Board determines that licensure would not be in the public interest. To determine whether licensure would not be in the public interest, the Board shall consider, at a minimum, the following factors: (1) Any conviction of the applicant under any federal, state, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances. (2) Any felony convictions of the applicant under federal, state, or local laws. (3) The applicant’s past experience in the manufacture or distribution of prescription drugs, including controlled substances. (4) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution. (5) Suspension or revocation by federal, state, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drug, including controlled substances. (6) Compliance with licensing requirements under previously granted licenses, if any. (7) Compliance with requirements to maintain or make available to the Board or to federal, state, or local law enforcement officials records required to be maintained or made available under this subchapter. (8) Any other factors or qualifications the Board considers relevant to and consistent with the public health and safety. Added 1991, No. 240 (Adj. Sess.), § 2; 2009, No. 35, § 36.

26 V.S.A. § 2071 Application of federal guidelines

2071. Application of federal guidelines (a) The requirements set forth in sections 2068 and 2069 of this chapter shall conform to wholesale distributor licensing guidelines formally adopted by the U.S. Food and Drug Administration (FDA). (b) In case of conflict between any wholesale distributor licensing requirement imposed by the Board under this chapter and any FDA wholesale distributor licensing guideline, the latter shall control. Added 1991, No. 240 (Adj. Sess.), § 2; amended 2017, No. 144 (Adj. Sess.), § 20.

26 V.S.A. § 2073 Rules

2073. Rules (a) The Board may adopt rules necessary to carry out the purposes of the provisions of this subchapter. (b) All rules adopted under this subchapter shall conform to wholesale distributor licensing guidelines formally adopted by the FDA at 21 C.F.R. Part 205. Added 1991, No. 240 (Adj. Sess.), § 2; amended 2017, No. 144 (Adj. Sess.), § 20.

26 V.S.A. § 2076 Inspection powers; access to wholesale distributor and manufacturer records

2076. Inspection powers; access to wholesale distributor and manufacturer records (a) A person authorized by the Board may enter, during normal business hours, all open premises purporting or appearing to be used by a wholesale distributor or manufacturer for purposes of inspection. (b)(1) Wholesale distributors and manufacturers may keep records regarding purchase and sales transactions at a central location apart from the principal office of the wholesale distributor or the location at which the drugs were stored and from which they were shipped, provided that such records shall be made available for inspection within two working days of a request by the Board. (2) Records may be kept in any form permissible under federal law applicable to prescription drugs record keeping. (c) If the Board determines it is necessary to inspect a certain premises under the same ownership more than once in any two-year period, the Board may charge a reinspection fee of not more than $500.00. Added 1991, No. 240 (Adj. Sess.), § 2; amended 2005, No. 27, § 53; 2017, No. 144 (Adj. Sess.), § 20; 2019, No. 30, § 14; 2019, No. 70, § 19.

Source: Vermont General Assembly (legislature.vermont.gov)URL: https://legislature.vermont.gov/statutes/chapter/26/036Fetched: 10/21/2026