Code of Vermont Rules › Agency 04 - SECRETARY OF STATE › Sub-Agency 030 - OFFICE OF PROFESSIONAL REGULATION › Chapter 230 - BOARD OF PHARMACY ADMINISTRATIVE RULES › Section 04 030 230 - BOARD OF PHARMACY ADMINISTRATIVE RULES

Current through June, 2024
PART 1 GENERAL
				INFORMATION
Section 1.1. The Board's Purpose.
The Vermont Board of Pharmacy ("the Board") has been created
				  and given powers by Vermont law, 26 V.S.A. Chapter 36. Its purpose is to
				  protect the health, safety, and welfare of the public. The Board does this by,
				  among other authority set forth in Chapter 36 and in Chapter 5 of Title 3,
				  setting standards for examining and licensing qualified applicants, and
				  regulating the practice of pharmacy.
Section 1.2. Board Restrictions.
The Board may not make any rule that is designed or
				  implemented to limit the number of licensees or pharmacies in the state; nor
				  may the Board require that nonprescription drugs be sold only by a pharmacist
				  or under a pharmacist's supervision.
Section 1.3. Business Address.
The Board is located at the Office of the Secretary of State,
				  Office of Professional Regulation, 89 Main St., Fl. 3, Montpelier, VT
				  05620-3402 ("the Office"). The Board's mailing address is the same. The Office
				  telephone number is 1802-828-1505. Applications, copies of these rules, and
				  additional information about the Board may be obtained by contacting the Office
				  or by accessing the Board's website,
http://vtprofessionals.org/
.
Section 1.4. Board Members and
				Officers.
The Board is composed of five licensed pharmacists, each with
				  at least five years' experience as a pharmacist in Vermont, and two members of
				  the public. Public members of the Board shall have no financial interest in the
				  field of Pharmacy, as defined in 26 V.S.A. § 2031 other than as consumers
				  or possible consumers. Members of the Board are appointed by the governor as
				  provided in 3 V.S.A. sections 129b and 2004. The Board elects a chair, a vice
				  chair and a secretary, and other officers from among its members. A list of the
				  names and addresses of Board members and officers may be obtained from the
				  Office or the website.
Section
				1.5. Hearings.
The Board conducts hearings in accordance with the
				  Administrative Rules for the Office of Professional Regulation, 3 V.S.A. §
				  129, and the provisions of the Vermont Administrative Procedure Act for
				  contested cases, 3 V.S.A. §§ 801 -816.
Section 1.6. Regular, Special, and Emergency
				Meetings.
The Board holds at least two regular meetings a year. The
				  chair or a majority of members may call a special or emergency meeting. A
				  majority of members constitute a quorum for all meetings. Contact the Office
				  for the date, time and location of scheduled meetings.
Section 1.7. Laws that Govern the Board.
(a) The Board is governed by the law in 26
				V.S.A. Chapter 36, that establishes its responsibilities for setting standards,
				issuing licenses, and regulating the profession. The Board is also governed by
				and exercises authority granted in Chapter 5 of Title 3 of the Vermont
				statutes. In addition, the Board must comply with several other statutes, such
				as the "Law of Professional Regulation," ( 3 V.S.A. §§121 - 132 ),
				the "Administrative Procedure Act" ( 3 V.S.A. §§ 801 -849 ), the
				"Right to Know Law" ( 1 V.S.A. §§ 311 - 314 ), and the "Access to
				Public Records Law" ( 1 V.S.A. §§ 315 -320). These laws establish
				rights for applicants, licensees, and the public. Please note that 3 V.S.A.
				§ 129a also defines unprofessional conduct which can be the basis of
				disciplinary action.
(b) Most town
				clerks and libraries have copies of the Vermont Statutes Annotated, which
				contain the complete text of these laws. The Vermont Statutes Annotated may
				also be accessed through the Internet at
http://www.leg.state.vt.us
.
(c) The profession of pharmacy is governed by
				other state and federal laws among which are the Generic Drug Law; Food, Drug,
				and Cosmetic Acts; the Health Insurance Portability and Accountability Act of
				1996 (HIPAA); laws and regulations governing the use of alcohol; Federal
				Controlled Substance Act,  21 U.S.C. §
												801  et seq.; Vermont Regulated Drug
				Act, 18 V.S.A. §§ 4201 - 42, and postal regulations to be followed
				when shipping legend drugs.
Section
				1.8. Rules of the Board.
(a) The
				Board is authorized to make these Rules under 26 V.S.A. §2032. These Rules
				govern Board proceedings and have the effect of law. The Board reviews these
				rules periodically and revises them as needed. These rules may be cited as "BOP
				Rule x.x"
(b) Violation of these
				rules may result in disciplinary action by the Board or other federal or state
				authorities.
Section 1.9.
				Abbreviations Used in These Rules.
As used in these rules:
(a) ACPE: Accreditation Council for Pharmacy
				Education.
(b) DEA: Drug
				Enforcement Administration.
(c)
				FDA: Food and Drug Administration.
(e) FPGEC: Foreign Pharmacy Graduate
				Examination Committee.
(f) FPGEE:
				Foreign Pharmacy Graduate Equivalence Examination.
(g) MPJE: Multistate Pharmacy Jurisprudence
				Examination.
(h) NABP: National
				Association of Boards of Pharmacy.
(i) NAPLEX: North American Pharmacy Licensure
				Examination.
(j) OPR: Office of
				Professional Regulation, or "office."
(k) TOEFL: Test of English as a Foreign
				Language.
(l) TSE: Test of Spoken
				English.
(m) VAWD: Verified
				Accredited Wholesale Distributor.
Section 1.10. Definitions.
(a) As used in these rules:
(1) "Administer" or "Administration" means
				the direct application of a drug to the body of a patient or research subject
				by injection, inhalation, ingestion, or any other means.
(2) "AMDS" means automated medication
				distribution system. An AMDS is an automated device or series of devices
				operated by an electronic interface with one or more computers that is used to
				prepare, package, or dispense specified dosage units of drugs for
				administration or dispensing to a patient or the ultimate user. "AMDS" includes
				a device that prepares and packages a drug for unit dose dispensing, that
				prepares and packages a drug into outpatient prescription vials, and that
				dispenses pre-packaged drugs.
(3)
				"Alternative evidence of the individual's identity" as referred to in 18 V.S.A.
				§ 4215b means documents which reasonably permit a pharmacist to conclude
				that the individual is who he or she purports to be.
(4) "Bona fide representative of a patient"
				as referred to in 18 V.S.A. § 4215b means an individual who is authorized
				by law, or known to the patient and authorized by the patient to receive drugs
				dispensed by prescription for the patient.
(5) "Bona fide representative of an animal
				owner" as referred to in 18 V.S.A. § 4215b means the owner of an animal or
				a person authorized by the owner to receive drugs dispensed by prescription for
				the animal.
(6) "Beyond-Use Date"
				means a date determined by a pharmacist and placed on a prescription label at
				the time of dispensing that is intended to indicate to the patient or caregiver
				a time beyond which the contents of the prescription are not recommended to be
				used.
(7) "Board of Pharmacy" or
				"Board" means the Vermont Board of Pharmacy, or its designee.
(8) "Collaborative Pharmacy Practice" means
				that portion of pharmacy practice where a pharmacist may perform certain
				patient care functions under a protocol of specified conditions or limitations
				in collaboration with a practitioner. Collaborative practice agreements must be
				in writing and are valid for up to one year. After one year, a new written
				agreement is necessary for the collaboration to continue. Each collaborative
				practice agreement shall include provisions for no less than an annual quality
				assurance review by the collaborating practitioner. A pharmacist may have
				collaborative practice agreements with more than one practitioner.
(9) "Compounding" means the preparation of
				any active ingredients or added substances into a drug product
(A) as the result of a practitioner's
				prescription drug order or initiative based on the
				practitioner/patient/pharmacist relationship in the course of professional
				practice, or;
(B) for the purpose
				of, or as an incident to, research, teaching, or chemical analysis and not for
				sale or dispensing. Compounding also includes the preparation of drugs or
				devices in anticipation of prescription drug orders based on routine, regularly
				observed prescribing patterns. Compounding does not include mixing,
				reconstituting, or other such acts that are performed in accordance with
				directions contained in approved labeling provided by the product's
				manufacturer.
(10)
				"Confidential Information" means information accessed, maintained by, or
				transmitted to the pharmacist in the patient's records or which is communicated
				to the patient as part of patient counseling, which is privileged and may be
				released only to the patient or, as the patient directs, to those
				practitioners, other authorized health care professionals, and other
				pharmacists where, in the pharmacist's professional judgment, such release is
				necessary to protect the patient's health and well-being; and to such other
				persons or governmental agencies authorized or required by law to receive such
				confidential information, regardless of whether such information is in the form
				of paper, preserved on microfilm, or is stored on electronic media.
(11) "Deliver" or "Delivery" means the
				actual, constructive, or attempted transfer of a drug or device from one person
				to another, whether or not for a consideration.
(12) "Device" means an instrument, apparatus,
				implement, machine, contrivance, implant, or other similar or related article,
				including any component part or accessory, which is required under federal law
				to bear the label, "Caution: Federal or State law requires dispensing by or on
				the order of a physician."
(13)
				"Dispense" or "Dispensing" means the interpretation, evaluation, and
				implementation of a prescription drug order, including the preparation and
				delivery of a drug or device to a patient or patient's agent in a suitable
				container appropriately labeled for subsequent administration to, or use by, a
				patient.
(14) "Distribute" or
				"Distribution" means the delivery of a drug or device other than by
				administering or dispensing.
(15)
				"Drug" means:
(A) articles recognized as drugs
				in any official compendium, or supplement thereto, designated from time to time
				by the Board for use in the diagnosis, cure, mitigation, treatment, or
				prevention of disease in humans or other animals;
(B) articles intended for use in the
				diagnosis, cure, mitigation, treatment, or prevention of disease in humans or
				other animals;
(C) articles (other
				than food) intended to affect the structure or any function of the body of
				humans or other animals; and
(D)
				articles intended for use as a component of any articles specified in clause
				(A) (B) or (C) of this definition.
(16) "Drug regimen review and/or "drug
				utilization review" includes but is not limited to the following activities:
(A) Evaluation of the prescription drug
				order(s) and patient record(s) for:
(1) known
				allergies;
(2) rational
				therapy-contraindications;
(3)
				reasonable dose and route of Administration; and
(4) reasonable directions for use:
(B) Evaluation of the prescription
				drug order(s) and patient record(s) for duplication of therapy;
(C) Evaluation of the prescription drug
				order(s) and patient record(s) for interactions:
(1) drug-drug;
(2) drug-food;
(3) drug-disease; and
(4) adverse drug reactions.
(D) Evaluation of the Prescription
				Drug Order(s) and patient record(s) for proper utilization (including over or
				underutilization), and optimum therapeutic outcomes.
(17) "Electronic Transmission" means
				transmission of information in electronic form or the transmission of the exact
				visual image of a document by way of electronic equipment.
(18) "Electronic transmission intermediary"
				means an entity that provides the infrastructure that connects the computer
				systems or other electronic devices used by health care providers, prescribers,
				pharmacies, health care facilities, pharmacy benefit managers, health insurers,
				third party administrators, and agents and contractors of those persons in
				order to facilitate the secure transmission of an individual's prescription
				drug order, refill, authorization request, claim, payment, or other
				prescription drug information.
(19)
				"Electronic digital signature" means an electronic signature based upon
				cryptographic methods of originator authentication, and computed so that the
				identity of the signer and the integrity of the data can be verified.
(20) "Emergency Situations" for the purposes
				of authorizing an oral Prescription Drug Order of a Schedule II controlled
				substance, means those situations in which the prescribing practitioner
				determines (1) that immediate administration of the controlled substance is
				necessary for proper treatment of the patient, (2) that no appropriate
				alternative treatment is available, including administration of a drug which is
				not a Schedule II controlled substance, and (3) that it is not reasonably
				possible for the prescribing practitioner to provide a written prescription
				drug order to be presented to the person dispensing the substance, prior to the
				dispensing.
(21) "Equivalent Drug
				Product" means a drug product which has the same active ingredient(s), strength
				or concentration, dosage form, and route of administration and which is
				formulated to contain the same amount of active ingredient(s) in the same
				dosage form and to meet the same compendial or other applicable standards
				(i.e., strength, quality, purity, and identity), but which may differ in
				characteristics, such as shape, scoring, configuration, packaging, excipients
				(including colors, flavors, preservatives), and expiration time.
(22) "Fine/Civil/Administrative Penalty" is a
				monetary penalty permitted by law assessed against a licensee for violation of
				federal or state statutes or rules governing the practice of the
				profession.
(23) "Home Infusion
				Pharmacy" means a pharmacy which compounds solutions for direct administration
				to a patient in a private residence, long-term care facility, or hospice
				setting by means of parenteral, intravenous, intramuscular, subcutaneous, or
				intraspinal infusion.
(24)
				"Labeling" means the process of preparing and affixing a label to any drug
				container exclusive, however, of the labeling by a manufacturer, packer, or
				distributor of a non-prescription drug or commercially packaged legend drug or
				device. Any such label shall include all information required by federal and
				state law or rule.
(25) "Legend
				drug" see definition of prescription drug below.
(26) "Long-Term Care Facility" means a
				nursing home, retirement care, mental care, or other facility or institution
				that provides extended health care to resident patients.
(27) "Manufacturer" means a person engaged in
				the manufacture of drugs or devices.
(28) "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, and includes any
				packaging or repackaging of the substance(s) or labeling or relabeling of its
				container, and the promotion and marketing of such drugs or devices.
				Manufacturing also includes the preparation and promotion of commercially
				available products from bulk compounds for resale by pharmacies, practitioners,
				or other persons.
(29) "Medical
				Order" means a lawful order of a practitioner that may or may not include a
				prescription drug order.
(30)
				"Medication Therapy Management" means a distinct service or group of services
				that optimize therapeutic outcomes for individual patients. Medication Therapy
				Management services are independent of, but can occur in conjunction with, the
				provision of a medication or a medical device.
(31) "Non-Prescription Drug" means a drug
				which may be sold without a prescription and which is labeled for use by the
				consumer in accordance with the requirements of the laws and rules of this
				state and the federal government.
(32) "Office" means Office of Professional
				Regulation.
(33) "Patient
				Counseling" means the oral communication by the pharmacist of information, as
				defined in the rules of the applicable Board, to the patient or caregiver, in
				order to ensure proper use of drugs and devices.
(34) "Person" means an individual,
				corporation, subsidiary, partnership, association, organization, affiliate
				organization, or any other legal entity, including government.
(35) "Pharmacist Care" is the provision by a
				pharmacist of medication therapy management services, with or without the
				dispensing of drugs or devices, intended to achieve outcomes related to the
				cure or prevention of a disease, elimination or reduction of a patient's
				symptoms, or arresting or slowing of a disease process, as defined in the Rules
				of the Board.
(36) "Pharmacist"
				means an individual currently licensed by this state to engage in the practice
				of pharmacy.
(37)
				"Pharmacist-Manager" (also referred to as "Pharmacist in Charge") means a
				pharmacist currently licensed in this state who has held an unencumbered
				license in this or another state for at least two years, who accepts
				responsibility for the operation of a pharmacy in conformance with all laws and
				rules pertinent to the practice of pharmacy and the distribution of drugs, and
				who is personally in full and actual charge of such pharmacy and
				personnel.
(38) "Pharmacy" means
				any place within this state where drugs are dispensed and pharmaceutical care
				is provided and any place outside of this state where drugs are dispensed and
				pharmaceutical care is provided to residents of this state.
(39) "Pharmacy Intern" is a person working
				toward licensure as a pharmacist as set forth in Part 4 of these
				rules.
(40) "Pharmacy, Scope Of
				Practice." See, 26 V.S.A. § 2032(a)(1). Pharmacy is that profession which
				is concerned with the art and science of preparing, from natural and synthetic
				sources, suitable and convenient materials for distribution and use in the
				treatment and prevention of disease. It embraces a knowledge of the
				identification, selection, preparation, preservation, combination, analysis,
				standardization of pharmacologic action, and therapeutic use of drugs and
				medicines. As a health care profession, it also embraces the interpretation,
				evaluation, and dispensing of prescription drugs or drug orders in the
				patient's best interest; immunization; participation in drug and device
				selection, drug administration, drug regimen reviews and drug or drug-related
				research; provision of patient counseling and the provision of those acts or
				services necessary to provide pharmaceutical care; and the responsibility for
				compounding and labeling of drugs and devices, proper and safe storage of drugs
				and devices and maintenance of proper records for them. It includes the
				management of drug therapy in collaboration with other health care providers
				responsible for patient care and the research, consultation, selection of drugs
				under protocol, and recommendation or provision of information necessary for
				drug therapy.
(41) "Practice of
				Telepharmacy" means the provision of pharmaceutical care through the use of
				telecommunications and information technologies to patients at a distance.
(A) "Practice of Telepharmacy Across State
				Lines" means the provision of pharmaceutical care through the use of
				telecommunications and information technologies that occurs when the patient is
				physically located within the jurisdiction and the pharmacist is located
				outside the jurisdiction.
(B) Those
				providing telepharmacy services must register with the Board and meet the
				requirements set forth in Rules 2.9 and 2.10.
(42) "Practitioner" means an individual
				currently licensed, registered, or otherwise authorized by the appropriate
				jurisdiction to prescribe and administer drugs in the course of professional
				practice.
(43) "Preceptor" means an
				individual who is currently licensed as a pharmacist by the Board of Pharmacy,
				who meets the qualifications as a preceptor under the rules of the Board, and
				participates in the instructional training of pharmacy interns.
(44) "Prescription Drug" or "Legend Drug"
				means a drug which is required under federal law to be labeled with either of
				the following statements prior to being dispensed or delivered:
(A) "Caution: Federal law prohibits
				dispensing without prescription;" or
(B) "Caution: Federal law restricts this drug
				to use by, or on the order of, a licensed veterinarian;" or
(C) a drug which is required by any
				applicable federal or state law or rule to be dispensed pursuant only to a
				prescription drug order or is restricted to use by practitioners
				only.
(45) "Prescription
				Drug Order" means a lawful order from an authorized prescriber for a drug or
				device for a specific patient, including orders derived from collaborative
				pharmacy practice, that is communicated directly to a pharmacist in a licensed
				pharmacy. Non-verbal non-electronic prescriptions must bear the signature of
				the prescriber.
(46) "Tamper
				resistant prescription form" means a form meeting the requirements of Rule
				9.5.
(47) "These Rules" mean the
				Administrative Rules of the Board of Pharmacy;
(48) "Primary Care" is the first level of
				contact of individuals, the family, and the community with the health care
				delivery system, bringing health care as close as possible to where people live
				and work, and constitutes the first element of a continuing health care
				process. (Areas of primary care where pharmacists provide pharmaceutical care
				include, but are not limited to, the following: chronic disease management;
				smoking cessation; maternal and child health; immunizations; family planning;
				self-care consulting; drug selection under protocol; treatment of common
				diseases and injuries; nutrition; and general health education and
				promotion.)
(49) "Repackage" means
				changing the container, wrapper, quantity, and labeling of a product or device
				to further the distribution of the drug or device.
(50) "Repackager" means one who repackages
				drugs or devices.
(51) "Signature"
				for purposes of a prescription, means an authorized prescriber's name
				handwritten by that person on a "hard" prescription, or that person's
				"electronic digital signature" as part of an electronic prescription sent
				directly to a pharmacy.
(52)
				"Significant Adverse Drug Reaction" means any drug-related incident that may
				result in serious harm, injury, or death to the patient.
(53) "Wholesale Distributor" means any person
				engaged in wholesale distribution of drugs, including but not limited to
				manufacturers, repackagers, own-label distributors, private-label distributors,
				jobbers, brokers, warehouses, including manufacturers' and distributors'
				warehouses, chain drug warehouses, and wholesale drug warehouses, independent
				wholesale drug traders, and retail pharmacies that conduct wholesale
				distributions.
Section
				1.11. Acts Which May Affect Licensure, Registration, or Renewal.
The Board may discipline or deny licensure, registration, or
				  renewal under these rules if any applicant, sole proprietor, partner, corporate
				  officer, or owner has engaged in unprofessional conduct violating these rules,
				  3 V.S.A. § 129a, and 26 V.S.A. § 2051, or acts which directly affect
				  the ability to practice pharmacy.
Section
				1.12. Licenses, Registrations, and First Renewal.
An applicant issued an initial license or registration within
				  90 days of the renewal date will not be required to renew or pay the renewal
				  fee. The license will be issued through the next full license period. An
				  applicant issued an initial license more than 90 days prior to the renewal
				  expiration date will be required to renew and pay the renewal fee.
Section 1.13. Renewals.
All licenses and registrations are renewed biennially on a
				  schedule as determined by the office.