§ 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 manufacture, 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; the labeling
or relabeling of the container of a drug or device for resale by a pharmacy, practitioner,
or other person; and virtual manufacturing by an entity that sells its own prescription
drug or device without physically possessing the product.
(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, only while assisting and under the
supervision of a licensed pharmacist, performs tasks relative to dispensing prescription
drugs, administering immunizations, and performing tests for COVID-19. Pharmacy technicians
shall administer immunizations and perform tests for COVID-19 in compliance and accordance
with section 2042a of this title.
(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) 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;
(iii) practicing pharmacy pursuant to a collaborative practice agreement; or
(iv) prescribing as provided under section 2023 of this subchapter.
(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)(A) “Wholesale distributor” means any person who is engaged in wholesale distribution
of prescription drugs, including virtual distribution by an entity that sells a prescription
drug or device without physically possessing the product.
(B) “Wholesale distributor” 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.
(21) “Self-administered hormonal contraceptive” means a contraceptive medication or device
approved by the U.S. Food and Drug Administration that prevents pregnancy by using
hormones to regulate or prevent ovulation and that uses an oral, transdermal, subcutaneous,
or vaginal route of administration.
(22) “Emergency contraception” means any drug approved by the U.S. Food and Drug Administration
as a contraceptive method for use after sexual intercourse, whether provided over
the counter or by prescription. (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; 2019, No. 30, § 14; 2019, No. 178 (Adj. Sess.), § 11, eff. Oct. 1, 2020; 2023, No. 15, § 11, eff. September 1, 2023; 2023, No. 77, § 7, eff. June 20, 2023.)
§ 2023. Clinical pharmacy; prescribing
(a) In accordance with applicable rules adopted by the Board, a pharmacist may engage
in the practice of clinical pharmacy, including prescribing as set forth in subsection
(b) of this section, provided that a pharmacist shall not:
(1) prescribe a regulated drug as defined in 18 V.S.A. § 4201;
(2) prescribe a biological product as defined in 18 V.S.A. § 4601, other than an insulin medication, an influenza vaccine or vaccine to mitigate a
significant public health risk, or, pursuant to a collaborative practice agreement,
another vaccine; or
(3) initiate antibiotic therapy, except pursuant to a collaborative practice agreement.
(b) A pharmacist may prescribe in the following contexts:
(1) Collaborative practice agreement. A pharmacist may prescribe, for the patient or patients of a prescribing practitioner
licensed pursuant to this title, within the scope of a written collaborative practice
agreement with that primary prescriber.
(A) The collaborative practice agreement shall require the pharmacist and collaborating
practitioner to contemporaneously notify each other of any change in the patient’s
pharmacotherapy or known medical status.
(B) Under a collaborative practice agreement, a pharmacist may select or modify antibiotic
therapy for a diagnosed condition under the direction of the collaborating practitioner.
(2) State protocol.
(A) A pharmacist may prescribe, order, or administer in a manner consistent with valid
State protocols that are approved by the Commissioner of Health after consultation
with the Director of Professional Regulation and the Board and the ability for public
comment:
(i) opioid antagonists;
(ii) epinephrine auto-injectors;
(iii) tobacco cessation products;
(iv) tuberculin purified protein derivative products;
(v) self-administered hormonal contraceptives, including subcutaneous depot medroxyprogesterone
acetate;
(vi) dietary fluoride supplements;
(vii) for patients 18 years of age or older, vaccinations recommended by the Centers for
Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP)
and administered consistently with the ACIP-approved immunization schedules, as may
be amended from time to time;
(viii) for patients five years of age or older, influenza vaccine, COVID-19 vaccine, and
subsequent formulations or combination products thereof;
(ix) in the event of a significant public health risk, an appropriate vaccine to mitigate
the effects on public health after finding that existing channels for vaccine administration
are insufficient to meet the public health need;
(x) emergency prescribing of albuterol or glucagon while contemporaneously contacting
emergency services;
(xi) tests for COVID-19 for individuals by entities holding a Certificate of Waiver pursuant
to the Clinical Laboratory Amendments of 1988 (42 U.S.C. § 263a). If a test for COVID-19, prescribed, ordered, or administered by a pharmacist in
accordance with this section and the resulting State protocol incidentally detects
influenza or human respiratory syncytial virus, a pharmacist shall advise the individual
tested that the results indicate influenza or human respiratory syncytial virus infection
and recommend to the individual to seek further care from an appropriate health care
provider;
(xii) tests for SARS-CoV for asymptomatic individuals or related serology for individuals
by entities holding a Certificate of Waiver pursuant to the Clinical Laboratory Amendments
of 1988 (42 U.S.C. § 263a); and
(xiii) emergency contraception.
(B)(i) State protocols shall be valid if signed by the Commissioner of Health and the Director
of Professional Regulation, and the Board of Pharmacy shall feature the active protocol
conspicuously on its website.
(ii) The Commissioner of Health may invalidate a protocol if the Commissioner finds that
the protocol’s continued operation would pose an undue risk to the public health,
safety, or welfare and signs a declaration to that effect. Upon such a declaration,
the Director shall remove the invalidated protocol from the Board website and shall
cause electronic notice of the protocol’s discontinuation to be transmitted to all
Vermont drug outlets.
(3) Accessory devices. A pharmacist may prescribe accessory-type devices, such as spacers, needles, and diabetic
testing supplies, where clinically indicated in the judgment of the pharmacist.
(4) Prescriber-authorized substitution. A prescribing practitioner licensed pursuant to this title may authorize a pharmacist
to substitute a drug with another drug in the same therapeutic class that would, in
the opinion of the pharmacist, have substantially equivalent therapeutic effect even
though the substitute drug is not a therapeutic equivalent drug, provided:
(A) the prescriber has clearly indicated that drug product substitution is permissible
by indicating “therapeutic substitution allowed” or similar designation;
(B) the drug product substitution is intended to ensure formulary compliance with the
patient’s health insurance plan or otherwise to minimize cost to the patient;
(C) the patient’s voluntary, informed consent is obtained in writing; and
(D) the pharmacist or designee notifies the prescriber which drug was dispensed as a substitute
within five days of dispensing.
(5) Over-the-counter availability. A pharmacist may prescribe over-the-counter drugs where appropriate to reduce costs
to the patient, such as by drawing from a health savings account or flexible spending
account.
(6) Short-term extensions.
(A) A pharmacist may extend a previous prescription in the absence of a collaborative
practice agreement or a State protocol so long as the pharmacist provides only sufficient
quantity to the patient until the patient is able to consult with another practitioner,
not to exceed a five-day supply or the smallest available unit, and takes all reasonable
measures to notify the patient’s primary care provider of record or the appropriate
original prescriber, if the original prescriber is different from the primary care
provider of record.
(B) A short-term extension shall be provided on a one-time basis.
(c) Board rules shall:
(1) specify the required elements of a collaborative practice agreement;
(2) prohibit conflicts of interest and inappropriate commercial incentives related to
prescribing, such as reimbursement based on brands or numbers of prescriptions filled,
renewing prescriptions without request by a patient, steering patients to particular
brands or selections of products based on any commercial relationships, or acceptance
of gifts offered or provided by manufactures in violation of 18 V.S.A. § 4631a;
(3) define appropriate bounds of short-term extension prescribing; and
(4) establish minimum standards for patient privacy in clinical consultation. (Added 2015, No. 173 (Adj. Sess.), § 6, eff. June 8, 2016; amended 2019, No. 178 (Adj. Sess.), § 11, eff. Oct. 1, 2020; 2021, No. 20, § 262; 2023, No. 15, § 11, eff. May 10, 2023; 2023, No. 77, § 8, eff. June 20, 2023.)