§ 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 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 (A), (B), or (C) of this subdivision (6).

(7) "Drug outlet" means all pharmacies, wholesalers, manufacturers, and other entities that are engaged in the 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;

(B) a person who deals in goods and services that are uniquely related to the practice of pharmacy;

(C) a person who has invested anything of value in a business that 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 a person, regardless of form, engaged in the manufacturing of drugs or devices.

(11)(A) "Manufacturing" means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis.

(B) "Manufacturing" includes the packaging or repackaging of a drug or device or the labeling or relabeling of the container of a drug or device for resale by a pharmacy, practitioner, or other person.

(12) "Nonprescription drugs" means nonnarcotic medicines or drugs that may be sold without a prescription and that 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.

(13) "Pharmacist" means an individual licensed under this chapter.

(14) "Pharmacy technician" means an individual who performs tasks relative to dispensing only while assisting and under the supervision and control of a licensed pharmacist.

(15)(A) "Practice of pharmacy" means:

(i) interpreting and evaluating prescription orders;

(ii) compounding, dispensing, and labeling drugs and legend devices (except labeling by a manufacturer, packer, or distributor of nonprescription drugs and commercially packaged legend drugs and legend devices);

(iii) participating in drug selection and drug utilization reviews;

(iv) properly and safely storing drugs and legend devices, and maintaining proper records therefor;

(v) advising, where necessary or where regulated, of therapeutic values, content, hazards, and use of drugs and legend devices;

(vi) providing patient care services within the pharmacist’s authorized scope of practice;

(vii) optimizing drug therapy through the practice of clinical pharmacy; and

(viii) performing or offering to perform those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of pharmacy.

(B) "Practice of clinical pharmacy" or "clinical pharmacy" means:

(i) the health science discipline in which, in conjunction with the patient’s other practitioners, a pharmacist provides patient care to optimize medication therapy and to promote disease prevention and the patient’s health and wellness;

(ii) providing patient care services within the pharmacist’s authorized scope of practice, including medication therapy management, comprehensive medication review, and postdiagnostic disease state management services; or

(iii) practicing pharmacy pursuant to a collaborative practice agreement.

(C) The Board shall not adopt any rule requiring that pharmacists or pharmacies be involved in the sale and distribution of nonprescription drugs; provided, however, that nothing in this subdivision (C) shall limit the authority of the Board to adopt rules applicable to the elective sale or distribution of nonprescription drugs by pharmacists or pharmacies.

(16) "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.

(17) "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.

(18) "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.

(19) "Wholesale 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.

(20) "Collaborative practice agreement" means a written agreement between a pharmacist and a health care facility or prescribing practitioner that permits the pharmacist to engage in the practice of clinical pharmacy for the benefit of the facility’s or practitioner’s patients. (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; 2015, No. 38, § 23, eff. May 28, 2015; 2015, No. 173 (Adj. Sess.), § 5, eff. June 8, 2016; 2017, No. 144 (Adj. Sess.), § 20.)