Sub-Chapter 1: General Provisions
§ 2021. Statement of purpose
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 other such materials as may be used in the diagnosis and treatment of injury, illness, and disease. (Added 1977, No. 266 (Adj. Sess.), § 1; amended 2011, No. 66, § 6, eff. June 1, 2011.)
§ 2022. Definitions
As used in this chapter:
(1) "Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing.
(2) "Blood component" means that part of blood separated by physical or mechanical means.
(3) "Board of Pharmacy" or "Board" means the Vermont State Board of Pharmacy.
(4) "Disciplinary action" or "disciplinary cases" includes any action taken by the Board against a licensee or others premised upon a finding of wrongdoing or unprofessional conduct by the licensee. It includes all sanctions of any kind, including obtaining injunctions, issuing warnings, and other similar sanctions.
(5) "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 to or use by a patient or other individual entitled to receive the prescription drug.
(6) "Drug" means:
(A) articles recognized as drugs in the official U.S. Pharmacopoeia, official national formulary, official homeopathic pharmacopoeia, other drug compendium, or any supplement to any of them;
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans;
(C) articles (other than food) intended to affect the structure or any function of the body of humans; and
(D) articles intended for use as a component of any articles specified in subdivision (6)(A), (B), or (C) of this section.
(7) "Drug outlet" means all pharmacies, nursing homes, convalescent homes, extended care facilities, drug abuse treatment centers, penal institutions, family planning clinics, retail stores, hospitals, wholesalers, manufacturers, any authorized treatment centers, and mail order vendors which are engaged in dispensing, delivery, or distribution of prescription drugs.
(8) "Drug sample" means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.
(9) "Financial interest" means being:
(A) a licensed practitioner of pharmacy; or
(B) a person who deals in goods and services which are uniquely related to the practice of pharmacy; or
(C) a person who has invested anything of value in a business which provides pharmacy services; or
(D) a person who is a parent, child, brother, sister, grandparent, or spouse of any person otherwise having a "financial interest" under this subsection.
(10) "Manufacturer" means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug.
(11) "Nonprescription drugs" means nonnarcotic medicines or drugs which may be sold without a prescription and which are prepackaged for use by the consumer and labeled in accordance with the requirements of the statutes and regulations of this State and the federal government.
(12) "Pharmacist" means an individual licensed under this chapter.
(13) "Pharmacy technician" means an individual who performs tasks relative to dispensing only while assisting, and under the supervision and control of, a licensed pharmacist.
(14) "Practice of pharmacy" means the interpretation and evaluation of prescription orders; the compounding, dispensing, and labeling of drugs and legend devices (except labeling by a manufacturer, packer, or distributor of nonprescription drugs and commercially packaged legend drugs and legend devices); the participation in drug selection and drug utilization reviews; the proper and safe storage of drugs and legend devices and the maintenance of proper records therefor; the responsibility for advising, where necessary or where regulated, of therapeutic values, content, hazards, and use of drugs and legend devices; and the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of pharmacy. A rule shall not be adopted by the Board under this chapter that shall require the sale and distribution of nonprescription drugs by a licensed pharmacist or under the supervision of a licensed pharmacist or otherwise interfere with the sale and distribution of such medicines.
(15) "Practitioner" means an individual authorized by the laws of the United States or its jurisdictions or Canada to prescribe and administer prescription drugs in the course of his or her professional practice and permitted by that authorization to dispense, conduct research with respect to, or administer drugs in the course of his or her professional practice or research in his or her respective state or province.
(16) "Prescription drug" means any human drug required by federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to Section 503(b) of the Federal Food, Drug and Cosmetic Act.
(17) "Wholesale distribution" means distribution of prescription drugs to persons other than a consumer or patient, but does not include:
(A) Intracompany sales, meaning any transaction or transfer between any division, subsidiary, parent, or affiliated or related company under common ownership and control of a corporate entity.
(B) The purchase or other acquisition by a hospital or other health care entity that 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 that are members of such organizations.
(C) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in Section 501(c)(3) of the U.S. Internal Revenue Code of 1986, as amended, to a nonprofit affiliate of the organization to the extent otherwise permitted by law.
(D) 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 that are under common control. For purposes of this subdivision, "common control" means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract or otherwise.
(E) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for "emergency medical reasons." For purposes of this subdivision, "emergency medical reasons" include transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage.
(F) 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.
(G) The distribution of drug samples by manufacturers' representatives or distributors' representatives.
(H) The sale, purchase, or trade of blood or blood components intended for transfusion.
(18) "Wholesale drug distributor" means any person who is engaged in wholesale distribution of prescription drugs, but does not include any for hire carrier or person hired solely to transport prescription drugs. (Added 1977, No. 266 (Adj. Sess.), § 1; amended 1981, No. 244 (Adj. Sess.), §§ 1, 2, 18; 1991, No. 240 (Adj. Sess.), § 1; 2003, No. 60, § 7; 2007, No. 163 (Adj. Sess.), § 12; 2009, No. 103 (Adj. Sess.), § 18; 2013, No. 27, § 22.)
Sub-Chapter 2: Board Of Pharmacy
§ 2031. Creation; appointment; terms; organization
(a) There is hereby created the board of pharmacy to enforce the provisions of this chapter. The board shall consist of seven members, five of whom shall be pharmacists licensed under this chapter with five years of experience in the practice of pharmacy in this state. Two members shall be members of the public having no financial interest in the practice of pharmacy.
(b) Members of the board shall be appointed by the governor pursuant to 3 V.S.A. §§ 129b and 2004. A majority of members shall constitute a quorum, and all action shall be taken upon a majority vote of the members present and voting. (Added 1977, No. 266 (Adj. Sess.), § 1; amended 1981, No. 244 (Adj. Sess.), § 3; 1997, No. 145 (Adj. Sess.), § 31; 2005, No. 27, § 49.)
§ 2032. Powers, duties, limitations
(a) The Board shall adopt rules necessary for the performance of its duties, including:
(1) scope of the practice of pharmacy;
(2) qualifications for obtaining licensure;
(3) explanations of appeal and other rights given to licensees, applicants, and the public; and
(4) rules regulating pharmacy technicians.
(b) The Board of Pharmacy shall supervise the practice of pharmacy in this State, including the following:
(1) the determination and issuance of standards for recognition and approval 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;
(2) the enforcement of those provisions of this chapter relating to the conduct or competence of pharmacists practicing in this State, and the suspension, revocation, or restriction of licenses to engage in the practice of pharmacy; and
(3) an internship program which shall have the following elements:
(A) a curriculum governing the internship which requires an intern to spend at least 50 percent of the internship on compounding, dispensing, or inventorying prescription drugs under the direct supervision of a licensed pharmacist, and maintaining required records;
(B) the establishment of a referral function administered by the Office of Professional Regulation whereby the Board collects information on available internships and disseminates this information to prospective interns; and
(C) allowance of up to 1,240 hours of the program to be "concurrent time" or internship time served under the supervision of, concurrent with, or part of an educational course requirement leading to a pharmacy degree, as defined by Board rule, or by equivalent service in any branch of the U.S. Armed Forces, as defined by Board rule.
(c) The Board of Pharmacy shall also have the following responsibilities in regard to medications, drugs, legend devices, 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 at retail and the dispensing of medications, drugs, legend devices, and other materials, including the right to seize any such drugs, legend devices, and other materials found to be detrimental to the public health and welfare by the Board pursuant to an appropriate hearing as required under the Administrative Procedure Act;
(2) The specifications of minimum professional and technical equipment, environment, supplies, and procedures for the compounding or dispensing of such medications, drugs, legend devices, and other materials within the practice of pharmacy;
(3) The control of the purity and quality of such medications, drugs, legend devices, and other materials within the practice of pharmacy;
(4) The issuance of certificates of registration and licenses of drug outlets; and
(5) The development of criteria for a standardized tamper-resistant prescription pad that can be used by all health care providers who prescribe drugs. Such criteria shall be developed in consultation with pharmacists, hospitals, nursing homes, physicians and other prescribers, and other affected parties.
(d) The Board:
(1) shall make examinations available at least twice each year and pass upon the qualifications of applicants for licensing; and
(2) may enact rules for continuing education requirements and approve continuing education programs.
(e) With the approval of the Board, the Director of the Office of Professional Regulation may employ or contract with persons as may be necessary to carry out the duties of the Board.
(f) The Board or its authorized representatives shall also have power to investigate and gather evidence concerning alleged violations of the provisions of this chapter or of the rules and regulations of the Board. The Board may take testimony under oath and may compel the attendance of witnesses and the production of tangible evidence by serving a subpoena.
(g) The Board may by rule adopt standards for creating, licensing, and operating remote pharmacies and automatic dispensing units in Vermont.
(h) It shall be lawful for a drug outlet licensed under this chapter to sell and distribute nonprescription drugs. Drug outlets engaging in the sale and distribution of such items shall not be deemed to be improperly engaged in the practice of pharmacy. A rule or regulation shall not be adopted by the Board under this chapter which shall require the sale of nonprescription drugs by a licensed pharmacist or under the supervision of a licensed pharmacist or otherwise apply to or interfere with the sale and distribution of such medicines. (Added 1977, No. 266 (Adj. Sess.), § 1; amended 1979, No. 158 (Adj. Sess.), § 4, eff. April 28, 1980; 1981, No. 244 (Adj. Sess.), § 4; 1983, No. 230 (Adj. Sess.), § 8; 1989, No. 250 (Adj. Sess.), § 4(d); 1997, No. 40, § 24; 2001, No. 127 (Adj. Sess.), § 2b, eff. June 13, 2002; 2003, No. 60, § 8; 2005, No. 148 (Adj. Sess.), § 17; 2007, No. 163 (Adj. Sess.), § 13; 2009, No. 4, § 104a, eff. April 29, 2009; 2009, No. 35, § 33; 2011, No. 66, § 6, eff. June 1, 2011; 2013, No. 27, § 23.)
Sub-Chapter 3: Licensing
§ 2041. Unlawful practice
(a) It shall be unlawful for any person to engage in the practice of pharmacy unless licensed to so practice under the provisions of this chapter provided, however, physicians, dentists, veterinarians, osteopaths, or other practitioners of the healing arts who are licensed under the laws of this state may dispense and administer prescription drugs to their patients in the practice of their respective professions where specifically authorized to do so by statute of this state.
(b) Any person who shall be found by the board after hearing to have unlawfully engaged in the practice of pharmacy shall be subject to disciplinary action. For the purpose of enforcing this section, the attorney general or a state's attorney or an attorney assigned by the office of professional regulation may commence a criminal action against any person unlawfully engaging in the practice of pharmacy, and upon conviction, the person shall be subject to the penalties provided in 3 V.S.A. § 127(c). (Added 1977, No. 266 (Adj. Sess.), § 1; amended 1981, No. 244 (Adj. Sess.), § 5; 2007, No. 29, § 31.)
§ 2042. Qualifications for licensure
(a) To obtain a license to engage in the practice of pharmacy, an applicant for licensure by examination shall:
(1) Have attained the age of majority;
(2) Have graduated and received the professional undergraduate degree from a school or college of pharmacy which has been approved by the board of pharmacy, or, for foreign-trained applicants, have successfully passed an examination demonstrating that their education was equivalent to the education at a board-approved school or college;
(3) If required by subdivision 2032(b)(3) of this title, have completed any internship program established by the board or demonstrated experience in the practice of pharmacy which meets or exceeds any internship requirement established under this chapter;
(4) Have successfully passed an examination required by the board of pharmacy;
(5) Paid the fees specified by this chapter.
(b) The board may license by endorsement an applicant who is licensed under the laws of another state whose requirements the board deems to be substantially equal to those of this state.
(c) Licensing standards promulgated by the board and its procedures shall be fair and reasonable and shall be designed and implemented to measure and reasonably ensure an applicant's qualifications to practice pharmacy. They shall not be designed or implemented for the purpose of limiting the number of licensees.
(d) If a licensee has a principal place of business, the license shall be prominently displayed at that place. (Added 1977, No. 266 (Adj. Sess.), § 1; amended 1981, No. 244 (Adj. Sess.), § 6; 1989, No. 250 (Adj. Sess.), § 52; 2009, No. 35, § 33a.)
§ 2042a. Pharmacy technicians; qualifications for registration
No person shall perform the duties of a pharmacy technician unless registered with the Board. To obtain a registration as a pharmacy technician, an applicant shall:
(1) not have engaged in acts which affect the ability of the applicant to practice as a pharmacy technician;
(2) if required by rules adopted by the Board, be certified or eligible for certification by a national pharmacy technician certification authority; and
(3) have paid the fee specified in section 2046 of this chapter. (Added 2003, No. 60, § 9; amended 2013, No. 138 (Adj. Sess.), § 12.)
§ 2042b. Pharmacy technicians; nondiscretionary tasks; supervision
(a) Notwithstanding any other provision of law, a registered pharmacy technician may perform packaging or other nondiscretionary tasks only while assisting and under the supervision and control of a pharmacist.
(b) This section does not authorize a pharmacy technician to perform packaging or other nondiscretionary tasks without a pharmacist on duty, and without being under the supervision and control of a pharmacist.
(c) This section does not authorize a pharmacy technician to perform any act requiring the exercise of professional judgment by a pharmacist.
(d) The Board may adopt rules to specify tasks that a pharmacy technician may perform under the supervision and control of a pharmacist pursuant to subsection (a) of this section. A pharmacy or pharmacist that employs a pharmacy technician to perform tasks specified in subsection (a) shall do so in conformity with the rules adopted by the Board pursuant to this section.
(f) A pharmacist on duty shall be directly responsible for the conduct of a pharmacy technician. A pharmacist responsible for a pharmacy technician shall be on the premises at all times. A pharmacist shall verify a prescription before medication is provided to the patient. (Added 2003, No. 60, § 10; amended 2005, No. 27, § 50; 2013, No. 27, § 24.)
§ 2043. Repealed. 1981, No. 244 (Adj. Sess.), § 17.
§ 2044. Renewal of licenses
Each person or entity licensed or regulated under the provisions of this chapter shall apply for renewal biennially by a date established by the director of the office of professional regulation. (Added 1977, No. 266 (Adj. Sess.), § 1; amended 1981, No. 244 (Adj. Sess.), § 7; 1989, No. 250 (Adj. Sess.), § 4(d); 2005, No. 148 (Adj. Sess.), § 18; 2011, No. 116 (Adj. Sess.), § 28.)
§ 2045. Reinstatement
(a) The board may renew a license which has lapsed upon payment of the required fee and the late renewal penalty, provided all the requirements for renewal set by the board by rule, have been satisfied. The board shall not require payment of renewal fees for years during which the license was lapsed.
(b) As a condition of renewal, the board may by rule set reinstatement requirements for those whose licenses have lapsed for more than five years. (Added 1981, No. 244 (Adj. Sess.), § 8; amended 1999, No. 133 (Adj. Sess.), § 17; 2009, No. 35, § 34.)
§ 2046. Fees
Applicants and persons regulated under this chapter shall pay the
(1) Initial application:
(A) Pharmacists $ 110.00
(B) Retail drug outlets $ 300.00
(C) Institutional drug outlets $ 300.00
(D) Manufacturing drug outlet $ 300.00
(E) Wholesale drug outlet $ 600.00
(F) Investigative and research projects $ 300.00
(G) Pharmacy technicians $ 50.00
(2) Biennial renewal:
(A) Pharmacists $ 100.00
(B) Retail drug outlets $ 300.00
(C) Institutional drug outlets $ 300.00
(D) Manufacturing drug outlet $ 300.00
(E) Wholesale drug outlet $ 300.00
(F) Investigative and research projects $ 300.00
(G) Pharmacy technicians $ 60.00
(3) Pharmacy reinspection $ 100.00
(Added 1981, No. 244 (Adj. Sess.), § 9; amended 1989, No. 250 (Adj. Sess.), § 53; 1991, No. 167 (Adj. Sess.), § 36; 1995, No. 47, § 24; 2003, No. 60, § 11; 2005, No. 27, § 51; 2007, No. 76, § 6.)
Sub-Chapter 4: Discipline
§ 2051. Unprofessional conduct
The board of pharmacy may refuse to issue or renew, or may suspend, revoke, or restrict the licenses of any person, pursuant to the procedures set forth in section 2052 of this title, upon one or more of the following grounds and upon the grounds set forth in 3 V.S.A. § 129a:
(1) Unprofessional conduct as that term is defined by the rules and regulations of the board;
(2) Incapacity of a nature that prevents a pharmacist from engaging in the practice of pharmacy with reasonable skill, competence, and safety to the public;
(3) Fraud or intentional misrepresentation by a licensee in securing the issuance or renewal of a license;
(4) Engaging or aiding and abetting an individual to engage in the practice of pharmacy without a license or to falsely use the title of pharmacist;
(5) Being found by the board to be in violation of any of the provisions of this chapter or rules and regulations adopted pursuant to this chapter. (Added 1977, No. 266 (Adj. Sess.), § 1; amended 1981, No. 244 (Adj. Sess.), § 10; 1997, No. 145 (Adj. Sess.), § 43.)
§ 2052. Penalties and reinstatement
(a)(1) Upon the finding, after notice and opportunity for hearing, of the existence of grounds for discipline of any person or any drug outlet holding a license, under the provisions of this chapter, the board of pharmacy may impose one or more of the following penalties:
(A) Suspension of the offender's license for a term to be determined by the board;
(B) Revocation of the offender's license;
(C) Restriction of the offender's license to prohibit the offender from performing certain acts or from engaging in the practice of pharmacy in a particular manner for a term to be determined by the board;
(D) Placement of the offender under the supervision of the board for a period to be determined and under conditions set by the board;
(E) A requirement to perform up to 100 hours of public service, in a manner and at a time and place to be determined by the board;
(F) A requirement of a course of education or training;
(G) An administrative penalty as provided in 3 V.S.A. § 129a(d).
(b) Any person or drug outlet whose license to practice pharmacy in this state has been suspended, revoked, or restricted pursuant to this chapter, whether voluntarily or by action of the board, shall have the right, at reasonable intervals, to petition the board for reinstatement of such license. Such petition shall be made in writing and in the form prescribed by the board. Upon hearing, the board may in its discretion grant or deny such petition or it may modify its original finding to reflect any circumstances which have changed sufficiently to warrant such modifications.
(c) Nothing herein shall be construed as barring criminal prosecutions for violations of this chapter where such violations are deemed as criminal offenses in other statutes of this state or of the United States.
(d) All final decisions by the board shall be subject to review pursuant to 3 V.S.A. § 130a. (Added 1977, No. 266 (Adj. Sess.), § 1; amended 1979, No. 158 (Adj. Sess.), § 5, eff. April 28, 1980; 1981, No. 244 (Adj. Sess.), § 11; 1989, No. 250 (Adj. Sess.), § 4(c); 1993, No. 108 (Adj. Sess.), § 10; 2007, No. 29, § 32.)
Sub-Chapter 5: Registration Of Facilities
§ 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 of the following classifications:
(1) Retail drug outlet;
(2) Institutional drug outlet;
(3) Manufacturing drug outlet;
(4) Wholesale drug outlet or wholesale drug distributor;
(5) Investigative and research projects.
(c) No individual who is employed by a corporation which 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 which 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. 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 section 2051 of this title. (Added 1977, No. 266 (Adj. Sess.), § 1; amended 1981, No. 244 (Adj. Sess.), § 12; 1991, No. 240 (Adj. Sess.), § 3; 2005, No. 27, § 52.)
§ 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:
(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.)
§ 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 rules and regulations.
(b) Disasters, thefts, accidents, and emergencies which 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.)
§ 2064. Violations and penalties
(a) No drug outlet designated in section 2061 of this title shall be operated until a license has been issued to said outlet by the board. Upon the finding of a violation of this section, the board may impose one or more of the penalties enumerated in section 2052 of this title.
(b) Reinstatement of a license that has been suspended, revoked, or restricted by the board may be granted in accordance with the procedures specified by subsection 2052(b) of this title. (Added 1977, No. 266 (Adj. Sess.), § 1; amended 1981, No. 244 (Adj. Sess.), § 15.)
Sub-Chapter 6: Wholesale Drug Distributors
§ 2067. Wholesale drug distributor; licensure required
(a) A person who is not licensed under this subchapter shall not engage in wholesale drug distribution in this State.
(c) The Board may require a separate license for each facility directly or indirectly owned or operated by the same business entity within this State, or for a parent entity with divisions, subsidiaries, or affiliate companies within this State 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 drug distributor 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.)
§ 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 which 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 all wholesale distributor 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, 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 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 which 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 applicable to wholesale drug distribution.
(10) Compliance with standards and procedures which 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 wholesale drug distributors 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, protection of a wholesale drug distributor's proprietary information, and any other requirements consistent with the purposes of this subdivision. The board rules may recognize third party accreditation in satisfaction of some or all of the requirements of this subdivision. (Added 1991, No. 240 (Adj. Sess.), § 2; amended 2005, No. 139 (Adj. Sess.), § 4.)
§ 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.)
§ 2070. Repealed. 2013, No. 27, § 27.
§ 2071. Application of federal guidelines
The requirements set forth in sections 2068 and 2069 of this title shall conform to wholesale drug distributor licensing guidelines formally adopted by the United States Food and Drug Administration (FDA). In case of conflict between any wholesale drug distributor licensing requirement imposed by the board under this chapter and any FDA wholesale drug distributor licensing guideline, the latter shall control. (Added 1991, No. 240 (Adj. Sess.), § 2.)
§ 2072. License renewal
Licenses and registrations shall be renewed biennially on a schedule as determined by the office of professional regulation. (Added 1991, No. 240 (Adj. Sess.), § 2; 2009, No. 35, § 37.)