reglab/statecodes huggingface dataset:
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › § 4307. Hearing; orders

§ 4307. Hearing; orders
When an inspection demonstrates that any establishment is being maintained or operated in violation of the provisions of this chapter or any related rules, the Commissioner shall provide written notice, together with an order commanding both abatement of the violation and compliance with this chapter within a reasonable period of time to be fixed in the order. Under any related rules adopted by the Commissioner, a person upon whom the notice and order are served shall be given an opportunity to be heard and to show cause as to why the order should be vacated or amended. When, upon a hearing, it appears that the provisions of this chapter have not been violated, the Commissioner shall immediately vacate the order, but without prejudice. When, however, it appears that the provisions have been violated and the person fails to comply with an order issued by the Commissioner under the provisions of this section, the Commissioner shall revoke, modify, or suspend the person’s license or enforce a civil penalty. (Amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2017, No. 76, § 5.)
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › § 4309. Penalty

§ 4309. Penalty
A person who violates a provision of this chapter or 6 V.S.A. § 3312(d), for which no other penalty is provided, shall be fined not more than $300.00 for the first offense and, for each subsequent offense, not more than $500.00. (Amended 2007, No. 38, § 8b, eff. May 21, 2007; 2017, No. 76, § 5.)
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › § 4351. License from Department of Health

§ 4351. License from Department of Health
(a) A person shall not operate or maintain a food manufacturing facility, retail food establishment, lodging establishment, children’s camp, seafood vending facility, or any other place in which food is prepared and served, unless he or she obtains and holds from the Commissioner a license authorizing such operation. All licenses shall be displayed in a manner as to be easily viewed by the public.
(b)(1) A person shall not knowingly and willingly sell or offer for sale a bulk product manufactured by a bakery, regardless of whether the bakery is located inside or outside the State, unless the operator of the bakery holds a valid license from the Commissioner.
(2) The Commissioner shall not grant a license to a bakery located outside the State unless:
(A) the person operating the bakery:
(i) has consented in writing to the Department’s inspection and paid the required fee; or
(ii) has presented to the Department satisfactory evidence of inspection and approval from the proper authority in his or her state and paid the required fee; and
(B) inspection of the bakery confirms that it meets the laws and rules of this State.
(c) The Commissioner may issue a temporary license for no more than 90 days. The temporary license shall state the conditions under which it is issued.
(d) If the Commissioner does not renew a license, he or she shall provide written notice to the licensee. The notice shall specify any changes necessary to conform with State rules and shall state that if compliance is achieved within the time designated in the notice, the license shall be renewed. If the licensee fails to achieve compliance within the prescribed time, the licensee shall have an opportunity for a hearing.
(e) Any licensee or applicant aggrieved by a decision or order of the Commissioner may appeal to the Superior Court of the county in which such person resides or maintains a place of business within 30 days after that decision.
(f) If a licensee fails to renew the licensee’s license within 60 days after its expiration date, a licensee shall apply for a new license and meet all licensure requirements anew. (Amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 1969, No. 242 (Adj. Sess.), eff. April 2, 1970; 1973, No. 98, § 7, eff. July 1, 1973; 1989, No. 103, § 1; 2017, No. 76, § 5; 2023, No. 6, § 149, eff. July 1, 2023; 2023, No. 53, § 119, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › § 4352. Application

§ 4352. Application
Prior to operating an establishment in which food is prepared and served or in which three or more lodging units are offered to the public, a person shall apply to the Commissioner upon forms supplied by the Department and shall pay a license fee as provided by section 4353 of this title. An application for licensure shall be submitted no fewer than 30 days prior to the opening of a food or lodging establishment. Upon receipt of such license fee and when satisfied that the premises are sanitary and healthful in accordance with the provisions of this chapter and related rules, the Commissioner shall issue a license to the applicant with respect to the premises described in the application. (Amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2017, No. 76, § 5.)
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › 4353. Fees

4353. Fees
(a) The Commissioner may establish by rule any requirement the Department needs to determine the applicable categories or exemptions for licenses. The following license fees shall be paid annually to the Department at the time of making the application according to the following schedules:
(1) Restaurants
I
Seating capacity of 0 to 25; $105.00
II
Seating capacity of 26 to 50; $180.00
III
Seating capacity of 51 to 100; $300.00
IV
Seating capacity of 101 to 200; $385.00
V
Seating capacity of 201 to 599; $450.00
VI
Seating capacity 600 and over; $1,000.00
VII
Home Caterer; $155.00
VIII
Commercial Caterer; $260.00
IX
Limited Operations; $140.00
X
Fair Stand; $125.00; if operating for four or more days per year; $230.00
(2) Lodging establishments
I
Lodging capacity of 1 to 10; $130.00
II
Lodging capacity of 11 to 20; $185.00
III
Lodging capacity of 21 to 50; $250.00
IV
Lodging capacity of 51 to 200; $390.00
V
Lodging capacity of over 200; $1,000.00
(3) Food manufacturing establishment - a fee for any person or persons that process food for resale to restaurants, stores, or individuals according to the following schedule:
(A)
Food manufacturing establishments; nonbakeries
I
Gross receipts of $10,001.00 to $50,000.00;
$175.00
II
Gross receipts of over $50,000.00; $275.00
III
Gross receipts of $10,000.00 or less are exempt
pursuant to section 4358
of this title
(B)
Food manufacturing establishment; bakeries
I
Home bakery; $100.00
II
Small commercial; $200.00
III
Large commercial; $350.00
(4) Seafood vending facility $200.00, unless operating pursuant to another license issued by the Department of Health and generating $40,000.00 or less in seafood gross receipts annually. If generating more than $40,000.00 in seafood gross receipts annually, the fee is to be paid regardless of whether the facility is operating pursuant to another license issued by the Department.
(5) Shellfish reshippers and repackers $375.00.
(6) Children s camps $150.00.
(b) The Commissioner of Health shall be the final authority on definition of categories contained in this section.
(c) All fees received by the Department under this section shall be credited to a special fund and shall be available to the Department to offset the cost of providing the services. (Amended 1959, No. 329 (Adj. Sess.), 27, eff. March 1, 1961; 1975, No. 118, 69, eff. April 30, 1975; 1985, No. 166 (Adj. Sess.), 1; 1989, No. 103, 2; 1995, No. 47, 5, eff. April 20, 1995; 1997, No. 155 (Adj. Sess.), 60, eff. July 1, 1999; 2001, No. 65, 7, 7a, eff. July 1, 2002, 7b, eff. July 1, 2003; 2007, No. 76, 12, eff. June 7, 2007; 2011, No. 128 (Adj. Sess.), 5; 2015, No. 57, 9; 2017, No. 76, 5.)
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › § 4354. Term of license

§ 4354. Term of license
A license shall expire annually on a date established by the Department and shall be renewed upon the payment of a new license fee if the licensee is in good standing with the Department. (Amended 1973, No. 98, § 8, eff. July 1, 1973; 1975, No. 118, § 70, eff. April 30, 1975; 2017, No. 76, § 5.)
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › § 4358. Exemptions

§ 4358. Exemptions
(a) The provisions of this subchapter shall apply only to those hotels, inns, restaurants, tourist camps, and other places that solicit the patronage of the public by advertising by means of signs, notices, placards, radio, electronic communications, or printed announcements.
(b) The provisions of this subchapter shall not apply to an individual manufacturing and selling bakery products from his or her own home kitchen whose average gross retail sales do not exceed $125.00 per week.
(c) Any food manufacturing establishment claiming a licensing exemption shall provide documentation as required by rule.
(d) The Commissioner shall not adopt a rule requiring food establishments that operate less than six months of the year and provide outdoor seating for fewer than 16 people at one time to provide toilet and hand washing facilities for patrons. (Amended 2017, No. 76, § 5.)
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › § 4391. Milk to be served in original container

§ 4391. Milk to be served in original container
A person, firm, or corporation owning or operating a hotel, restaurant, store, lunch room, fountain, roadside booth or stand, or a boarding house that makes a practice of serving meals to transients and who purchases milk for resale or to serve to his or her patrons shall not either directly or by an agent, servant, or employee sell or serve milk for drinking purposes to his or her patrons unless such milk is served or sold in the original bottle or like container in which the milk was delivered to such hotel, restaurant, store, lunch room, fountain, roadside lunch booth or stand, or boarding house.
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › § 4392. Exceptions; dispensing devices

§ 4392. Exceptions; dispensing devices
(a) The provisions of section 4391 of this title shall-not be construed to prevent or prohibit a person, firm, or corporation from purchasing milk in bulk for uses other than for serving patrons for drinking purposes, nor to prevent the sale or serving of cream, skimmed milk, or buttermilk from bulk, if the same is pure and wholesome and is sold and served as cream, skimmed milk, or buttermilk, nor shall it prevent or prohibit the sale of milk in mixed drinks at soda fountains, or from original bulk containers equipped with a dispensing device, provided the owner of such device has notified the Department of Health and the Agency of Agriculture, Food and Markets of each device installed and its location and has complied in all other respects with the rules of the Secretary of Agriculture, Food and Markets as provided in this subchapter.
(b) Milk or chocolate milk dispensed from any such device shall be homogenized and pasteurized and flavored skimmed milk shall be pasteurized. The words “chocolate milk,” as used in this subsection, shall be construed to mean milk of a butterfat content of not less than 3.5 percent butterfat to which chocolate has been added and any flavored milk drink with a content of less than 3.5 percent butterfat shall be labeled “Flavored Drink” according to the flavor used. (Amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 1989, No. 256 (Adj. Sess.), § 10(a), eff. Jan. 1, 1991; 2003, No. 42, § 2, eff. May 27, 2003; 2017, No. 113 (Adj. Sess.), § 86; 2023, No. 6, § 150, eff. July 1, 2023; 2023, No. 53, § 120, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › § 4393. Rulemaking

§ 4393. Rulemaking
The Secretary of Agriculture, Food and Markets shall, subject to approval by the Department of Health, make and adopt such rules as the Secretary deems necessary relating to the construction, operation, and use of such dispensing devices. (Amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2003, No. 42, § 2, eff. May 27, 2003; 2017, No. 113 (Adj. Sess.), § 87; 2023, No. 53, § 121, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › § 4466. Inspection

§ 4466. Inspection
(a) The Commissioner may inspect through his or her duly authorized officers, inspectors, agents, or assistants, at all reasonable times, a short-term rental and the operator’s records related to the short-term rental.
(b) Whenever an inspection demonstrates that the short-term rental is not operated in accordance with applicable provisions of this chapter, the officer, inspector, agent, or assistant shall notify the operator of the conditions found and shall direct necessary changes.
(c) Nothing in this section shall be construed to supersede the authority and responsibilities of the Division of Fire Safety. The Division’s Executive Director shall inform the Commissioner in a timely manner of any enforcement actions that the Division has taken against the operator of a short-term rental. (Added 2018, No. 10 (Sp. Sess.), § 1; amended 2019, No. 14, § 49, eff. April 30, 2019.)
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › § 4467. Posting contact information

§ 4467. Posting contact information
A short-term rental operator shall post within the unit a telephone number for the person responsible for the unit and the contact information for the Department of Health and the Department of Public Safety’s Division of Fire Safety. (Added 2018, No. 10 (Sp. Sess.), § 1.)
2023 Vermont Statutes › Title 18 - Health › Chapter 85 - Food and Lodging Establishments › § 4468. Educational materials

§ 4468. Educational materials
(a) The Department of Health, in collaboration with the Department of Public Safety’s Division of Fire Safety, shall prepare a packet of information pertaining to the health, safety, and financial obligations of short-term rental operators, including information regarding the importance of reviewing options for property and liability insurance with the operator’s insurance company.
(b) Included with the information packet set forth in subsection (a) of this section shall be a self-certification form pertaining to health and safety precautions that short-term rental operators must take into consideration prior to renting a unit. The form shall be retained by the operator and need not be filed with the Department. (Added 2018, No. 10 (Sp. Sess.), § 1.)
2023 Vermont Statutes › Title 18 - Health › Chapter 89 - Drug Paraphernalia › § 4475. Definitions

§ 4475. Definitions
(a) As used in this chapter:
(1) The term “drug paraphernalia” means all equipment, products, devices, and materials of any kind that are used, or promoted for use or designed for use, in planting, propagating, cultivating, growing, harvesting, manufacturing, compounding, converting, producing, processing, preparing, testing, analyzing, packaging, repackaging, storing, containing, concealing, injecting, ingesting, inhaling, or otherwise introducing into the human body a regulated drug in violation of chapter 84 of this title. “Drug paraphernalia” does not include needles, syringes, or other harm reduction supplies distributed or possessed as part of an organized community-based needle exchange program.
(2) “Organized community-based needle exchange program” means a program approved by the Commissioner of Health under section 4478 of this title, the purpose of which is to provide access to clean needles and syringes, and that is operated by an AIDS service organization, a substance abuse treatment provider, or a licensed health care provider or facility. Such programs shall be operated in a manner that is consistent with the provisions of 10 V.S.A. chapter 159 (waste management; hazardous waste), and any other applicable laws.
(b) In determining whether an object is drug paraphernalia, a court or other authority may consider, in addition to all other logically relevant factors, the following:
(1) statements by an owner or by anyone in control of the object concerning its use;
(2) the proximity of the object to regulated drugs;
(3) the existence of any residue of regulated drugs on the object;
(4) direct or circumstantial evidence of the intent of an owner, or of anyone in control of the object, to sell to persons intending to use the object in violation of this chapter;
(5) instructions, oral or written, provided with the object concerning its use;
(6) descriptive materials accompanying the object that explain or depict its use;
(7) national and local advertising concerning its use;
(8) the manner in which the object is displayed for sale;
(9) whether the owner, or anyone in control of the object, is a legitimate supplier of like or related items to the community, such as a licensed distributor or dealer of tobacco products;
(10) direct or circumstantial evidence of the ratio of sales of the object to the total sales of the business enterprise;
(11) the existence and scope of legitimate uses for the object in the community; and
(12) expert testimony concerning its use. (Added 1983, No. 186 (Adj. Sess.); amended 1999, No. 28, § 2; 2023, No. 22, § 5, eff. May 25, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 89 - Drug Paraphernalia › § 4476. Offenses and penalties

§ 4476. Offenses and penalties
(a) A person who sells drug paraphernalia to a person under 18 years of age shall be imprisoned for not more than two years or fined not more than $2,000.00, or both.
(b) The distribution and possession of needles and syringes as part of an organized community-based needle exchange program shall not be a violation of this section or of chapter 84 of this title. (Added 1983, No. 186 (Adj. Sess.); amended 1999, No. 28, § 3; 2017, No. 86 (Adj. Sess.), § 12.)
2023 Vermont Statutes › Title 18 - Health › Chapter 89 - Drug Paraphernalia › § 4477. Forfeiture

§ 4477. Forfeiture
Upon conviction under section 4476 of this title, the defendant shall forfeit to the State all items used, promoted for use, or designed for use as drug paraphernalia. (Added 1983, No. 186 (Adj. Sess.).)
2023 Vermont Statutes › Title 18 - Health › Chapter 89 - Drug Paraphernalia › § 4478. Needle exchange programs

§ 4478. Needle exchange programs
The Department of Health, in collaboration with the statewide harm reduction coalition, shall develop operating guidelines for needle exchange programs. If a program complies with such operating guidelines and with existing laws and rules, it shall be approved by the Commissioner of Health. Such operating guidelines shall be established not later than September 30, 1999. (Added 1999, No. 28, § 4; amended 2023, No. 6, § 151, eff. July 1, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 90 - Hearing AIDS › § 4501. Definitions

§ 4501. Definitions
As used in this chapter:
(1) “Health care practitioner” means an individual licensed by the Board of Medical Practice or the Office of Professional Regulation to provide professional health care services in this State.
(2)(A) “Stem cell and stem cell-related products” means any articles that contain or consist, or purport to contain or consist, of one or more of the following, when intended for implantation, transplantation, infusion, or transfer into a human recipient and when intended for use in the diagnosis, cure, mitigation, treatment, or prevention of any disease or condition based on or in connection with a proven or purported attribute of stem cells:
(i) human cells, including cells from tissues such as bone marrow; adipose tissue; amniotic membrane; umbilical cord blood, when not autologous or in a first- or second-degree relative; placenta; and other tissue or cell sources;
(ii) intracellular or extracellular components or vesicles; or
(iii) amniotic fluid.
(B) For purposes of this chapter, “stem cell and stem cell-related products” does not include the use of whole blood or blood products for routine transfusions or use of hematopoietic stem cells for reconstitution of bone marrow after treatment of blood-related cancers or diseases such as leukemias or lymphomas. (Added 2021, No. 61, § 1.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4601. Definitions

§ 4601. Definitions
As used in this chapter:
(1) “Biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition in human beings.
(2) “Brand name” means the registered trademark name given to a drug product by its manufacturer or distributor.
(3) “Generic drug” means a drug listed by generic name and considered to be chemically and therapeutically equivalent to a drug listed by brand name, as both names are identified in the most recent edition of or supplement to the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).
(4) “Generic name” means the official name of a drug product as established by the U. S. Adopted Names Council (USAN) or its successor, if applicable.
(5) “Interchangeable biological product” means a biological product that the U.S. Food and Drug Administration has:
(A) licensed and determined, pursuant to 42 U.S.C. § 262(k)(4), to be interchangeable with the reference product against which it was evaluated as may be reflected in the U.S. Food and Drug Administration’s Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (the Purple Book); or
(B) determined to be therapeutically equivalent as set forth in the latest edition of or supplement to the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).
(6) “Pharmacist” means a natural person licensed by the State Board of Pharmacy to prepare, compound, dispense, and sell drugs, medicines, chemicals, and poisons.
(7) “Prescriber” means any duly licensed physician, dentist, veterinarian, or other practitioner licensed to write prescriptions for the treatment or prevention of disease in man or animal.
(8) “Proper name” means the nonproprietary name of a biological product.
(9) “Reference product” means the single biological product licensed pursuant to 42 U.S.C. § 262(a) against which the interchangeable biological product was evaluated by the U.S. Food and Drug Administration pursuant to 42 U.S.C. § 262(k). (Added 1977, No. 127 (Adj. Sess.), § 1; amended 2001, No. 63, § 124; 2017, No. 193 (Adj. Sess.), § 1.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4606. Brand certification

§ 4606. Brand certification
If the prescriber has determined that the generic equivalent of a drug or the interchangeable biological product for the biological product being prescribed has not been effective or with reasonable certainty is not expected to be effective in treating the patient’s medical condition or causes or is reasonably expected to cause adverse or harmful reactions in the patient, the prescriber shall indicate “brand necessary,” “no substitution,” “dispense as written,” or “DAW” in the prescriber’s own handwriting on the prescription blank or shall indicate the same using electronic prescribing technology and the pharmacist shall not substitute the generic equivalent or interchangeable biological product. If a prescription is unwritten and the prescriber has determined that the generic equivalent of the drug or the interchangeable biological product for the biological product being prescribed has not been effective or with reasonable certainty is not expected to be effective in treating the patient’s medical condition or causes or is reasonably expected to cause adverse or harmful reactions in the patient, the prescriber shall expressly indicate to the pharmacist that the brand-name drug or biological product is necessary and substitution is not allowed and the pharmacist shall not substitute the generic equivalent drug or interchangeable biological product. (Added 1977, No. 127 (Adj. Sess.), § 1; amended 2001, No. 63, § 124; 2009, No. 103 (Adj. Sess.), § 4; 2017, No. 193 (Adj. Sess.), § 3.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4607. Information; labeling

§ 4607. Information; labeling
(a) Every pharmacy in the State shall have posted a sign in a prominent place that is in clear unobstructed view that shall read: “Vermont law requires pharmacists in some cases to select a less expensive generic equivalent drug or interchangeable biological product for the drug or biological product prescribed unless you or your physician direct otherwise. Ask your pharmacist.”
(b) The label of the container of all drugs and biological products dispensed by a pharmacist under this chapter shall indicate the generic or proper name using an abbreviation if necessary, the strength of the drug or biological product, if applicable, and the name or number of the manufacturer or distributor. (Added 1977, No. 127 (Adj. Sess.), § 1; amended 2001, No. 63, § 124; 2009, No. 103 (Adj. Sess.), § 5; 2017, No. 193 (Adj. Sess.), § 4.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4608. Liability

§ 4608. Liability
(a) Nothing in this chapter shall affect a licensed hospital with the development and maintenance of a hospital formulary system in accordance with that institution’s policies and procedures that pertain to its drug distribution system developed by the medical staff in cooperation with the hospital’s pharmacist and administration.
(b) The substitution of a generic drug or interchangeable biological product by a pharmacist under the provisions of this chapter does not constitute the practice of medicine. (Added 1977, No. 127 (Adj. Sess.), § 1; amended 2017, No. 193 (Adj. Sess.), § 5.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4621. Definitions

§ 4621. Definitions
Except as otherwise specified, for the purposes of this subchapter:
(1) “Department” means the Department of Health.
(2) “Evidence-based” means based on criteria and guidelines that reflect high-quality, cost-effective care. The methodology used to determine such guidelines shall meet recognized standards for systematic evaluation of all available research and shall be free from conflicts of interest. Consideration of the best available scientific evidence does not preclude consideration of experimental or investigational treatment or services under a clinical investigation approved by an institutional review board. (Added 2007, No. 80, § 14; amended 2009, No. 156 (Adj. Sess.), § I.21.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4622. Evidence-based education program

§ 4622. Evidence-based education program
(a)(1) The Department of Health, in collaboration with the Attorney General, the University of Vermont area health education centers program, and the Department of Vermont Health Access, shall establish an evidence-based prescription drug education program for health care professionals designed to provide information and education on the therapeutic and cost-effective utilization of prescription drugs to physicians, pharmacists, and other health care professionals authorized to prescribe and dispense prescription drugs. To the extent practicable, the program shall use the evidence-based standards developed by the Blueprint for Health. The Department of Health may collaborate with other states in establishing this program.
(2) The program shall notify prescribers about commonly used brand-name drugs for which the patent has expired within the last 12 months or will expire within the next 12 months. The Departments of Health and of Vermont Health Access shall collaborate in issuing the notices.
(3) To the extent permitted by funding, the program may include population-based medication management.
(b) The Department of Health shall request information and collaboration from physicians, pharmacists, private insurers, hospitals, pharmacy benefit managers, the Drug Utilization Review Board, medical schools, the Attorney General, and any other programs providing an evidence-based education to prescribers on prescription drugs in developing and maintaining the program.
(c) The Department of Health may contract for technical and clinical support in the development and the administration of the program from entities conducting independent research into the effectiveness of prescription drugs.
(d) The Department of Health and the Attorney General shall collaborate in reviewing the marketing activities of pharmaceutical manufacturing companies in Vermont and determining appropriate funding sources for the program, including awards from suits brought by the Attorney General against pharmaceutical manufacturers. (Added 2007, No. 80, § 14; amended 2009, No. 156 (Adj. Sess.), § I.22; 2011, No. 63, § E.311.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4633. Pharmaceutical marketer price disclosure

§ 4633. Pharmaceutical marketer price disclosure
(a) When a pharmaceutical marketer engages in any form of prescription drug marketing directly to a physician or other person authorized to prescribe prescription drugs, the marketer shall disclose to the physician or other prescriber the average wholesale price (AWP) of the drugs being marketed. Disclosure shall include the AWP per pill and the price relationship between the drug being marketed and other drugs within the same therapeutic class.
(b) The disclosures required under this section shall be on a form and in a manner prescribed by the Office of the Attorney General. The Attorney General may adopt rules to implement the provisions of this section.
(c) In addition to any other remedy provided by law, the Attorney General after consultation with the Commissioner of Financial Regulation may file an action in Superior Court for a violation of this section or of rules adopted under this section. In any such action, the Attorney General shall have the same authority to investigate and to obtain remedies as if the action were brought under the Consumer Protection Act, 9 V.S.A. chapter 63. Each violation of this section or of rules adopted under this section constitutes a separate civil violation for which the Attorney General may obtain relief.
(d) As used in this section:
(1) “Average wholesale price” or “AWP” means the wholesale price charged on a specific commodity that is assigned by the pharmaceutical manufacturing company and listed in a nationally recognized drug pricing file.
(2) “Pharmaceutical manufacturing company” shall have the same meaning as “pharmaceutical manufacturer” in section 4631a of this title.
(3) “Pharmaceutical marketer” means a person who, while employed by or under contract to represent a pharmaceutical manufacturing company, engages in marketing as that term is defined in section 4631a of this title. (Added 2003, No. 122 (Adj. Sess.), § 128c; amended 2007, No. 80, § 5; 2009, No. 59, § 6; 2011, No. 78 (Adj. Sess.), § 2, eff. April 2, 2012; 2011, No. 109 (Adj. Sess.), § 3, eff. May 8, 2012; 2011, No. 136 (Adj. Sess.), § 1b, eff. May 18, 2012.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4634. Prescription drug price disclosure

§ 4634. Prescription drug price disclosure
(a) Upon request, a pharmacy shall disclose to any consumer or health care provider the usual and customary retail price of a prescription drug.
(b) With each prescription dispensed, a pharmacy shall disclose to the consumer, in writing, the price of the prescription and any payment toward the price required of the consumer.
(c) For purposes of this section:
(1) “Price of the prescription” means the amount charged by the pharmacy to the consumer or, if applicable, to the consumer’s health benefit plan.
(2) “Usual and customary retail price” means the total price charged to a consumer who does not have prescription drug coverage under a health benefit plan.
(d) In addition to any other remedy provided by law, the Attorney General may file an action in Superior Court for a violation of this section. In any such action, the Attorney General shall have the same authority to investigate and to obtain remedies as if the action were brought under the Consumer Protection Act, 9 V.S.A. chapter 63. Each violation of this section constitutes a separate civil violation for which the Attorney General may obtain relief. (Added 2003, No. 122 (Adj. Sess.), § 128a; amended 2011, No. 109 (Adj. Sess.), § 3, eff. May 8, 2012; 2011, No. 136 (Adj. Sess.), § 1b, eff. May 18, 2012.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4636. Impact of prescription drug costs on health insurance premiums; report

§ 4636. Impact of prescription drug costs on health insurance premiums; report
(a)(1) Each health insurer with more than 1,000 covered lives in this State for major medical health insurance shall report to the Green Mountain Care Board for all covered prescription drugs, including generic drugs, brand-name drugs, and specialty drugs provided in an outpatient setting or sold in a retail setting:
(A) the 25 most frequently prescribed drugs and the average wholesale price for each drug;
(B) the 25 most costly drugs by total plan spending and the average wholesale price for each drug; and
(C) the 25 drugs with the highest year-over-year price increases and the average wholesale price for each drug.
(2) A health insurer shall not be required to provide to the Green Mountain Care Board the actual price paid, net of rebates, for any prescription drug.
(b) The Green Mountain Care Board shall compile the information reported pursuant to subsection (a) of this section into a consumer-friendly report that demonstrates the overall impact of drug costs on health insurance premiums. The data in the report shall be aggregated and shall not reveal information as specific to a particular health benefit plan.
(c) The Board shall publish the report required pursuant to subsection (b) of this section on its website on or before January 1 of each year. (Added 2017, No. 193 (Adj. Sess.), § 8, eff. May 30, 2018.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4637. Notice of introduction of new high-cost prescription drugs

§ 4637. Notice of introduction of new high-cost prescription drugs
(a) As used in this section:
(1) “Manufacturer” shall have the same meaning as “pharmaceutical manufacturer” in section 4631a of this title.
(2) “Prescription drug” means a drug as defined in 21 U.S.C. § 321.
(b) A prescription drug manufacturer shall notify the Office of the Attorney General in writing if it is introducing a new prescription drug to market at a wholesale acquisition cost that exceeds the threshold set for a specialty drug under the Medicare Part D program. The manufacturer shall provide the written notice within three calendar days following the release of the drug in the commercial market. A manufacturer may make the notification pending approval by the U.S. Food and Drug Administration (FDA) if commercial availability is expected within three calendar days following the approval.
(c) Not later than 30 calendar days following notification pursuant to subsection (b) of this section, the manufacturer shall provide all of the following information to the Office of the Attorney General in a format that the Office prescribes:
(1) a description of the marketing and pricing plans used in the launch of the new drug in the United States and internationally;
(2) the estimated volume of patients who may be prescribed the drug;
(3) whether the drug was granted breakthrough therapy designation or priority review by the FDA prior to final approval; and
(4) the date and price of acquisition if the drug was not developed by the manufacturer.
(d) The manufacturer may limit the information reported pursuant to subsection (c) of this section to that which is otherwise in the public domain or publicly available.
(e) The Office of the Attorney General shall publish on its website at least quarterly the information reported to it pursuant to this section. The information shall be published in a manner that identifies the information that is disclosed on a per-drug basis and shall not be aggregated in a manner that would not allow identification of the drug.
(f) The Attorney General may bring an action in the Civil Division of the Superior Court, Washington County for injunctive relief, costs, and attorney’s fees and to impose on a manufacturer that fails to provide the information required by subsection (c) of this section a civil penalty of not more than $1,000.00 per day for every day after the notification period described in subsection (b) of this section that the required information is not reported. In any action brought pursuant to this section, the Attorney General shall have the same authority to investigate and to obtain remedies as if the action were brought under the Consumer Protection Act, 9 V.S.A. chapter 63. (Added 2017, No. 193 (Adj. Sess.), § 10, eff. May 30, 2018.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4651. Wholesale importation program for prescription drugs; design

§ 4651. Wholesale importation program for prescription drugs; design
(a) The Agency of Human Services, in consultation with interested stakeholders and appropriate federal officials, shall design a wholesale prescription drug importation program that complies with the applicable requirements of 21 U.S.C. § 384, including the requirements regarding safety and cost savings. The program design shall:
(1) designate a State agency that shall either become a licensed drug wholesaler or contract with a licensed drug wholesaler in order to seek federal certification and approval to import safe prescription drugs and provide significant prescription drug cost savings to Vermont consumers;
(2) use Canadian prescription drug suppliers regulated under the laws of Canada or of one or more Canadian provinces, or both;
(3) ensure that only prescription drugs meeting the U.S. Food and Drug Administration’s safety, effectiveness, and other standards shall be imported by or on behalf of the State;
(4) import only those prescription drugs expected to generate substantial savings for Vermont consumers;
(5) ensure that the program complies with the tracking and tracing requirements of 21 U.S.C. §§ 360eee and 360eee-1 to the extent feasible and practical prior to imported drugs coming into the possession of the State wholesaler and that it complies fully after imported drugs are in the possession of the State wholesaler;
(6) prohibit the distribution, dispensing, or sale of imported products outside Vermont’s borders;
(7) recommend a charge per prescription or another method of support to ensure that the program is funded adequately in a manner that does not jeopardize significant consumer savings; and
(8) include a robust audit function.
(b) On or before January 1, 2019, the Secretary of Human Services shall submit the proposed design for a wholesale prescription drug importation program to the House Committees on Health Care and on Ways and Means and the Senate Committees on Health and Welfare and on Finance. (Added 2017, No. 133 (Adj. Sess.), § 1, eff. May 21, 2018.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4652. Monitoring for anticompetitive behavior

§ 4652. Monitoring for anticompetitive behavior
The Agency of Human Services shall consult with the Office of the Attorney General to identify the potential, and to monitor, for anticompetitive behavior in industries that would be affected by a wholesale prescription drug importation program. (Added 2017, No. 133 (Adj. Sess.), § 1, eff. May 21, 2018.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4653. Federal compliance

§ 4653. Federal compliance
(a) On or before July 1, 2020, the Agency of Human Services shall submit a formal request to the Secretary of the U.S. Department of Health and Human Services for certification of the State’s wholesale prescription drug importation program.
(b) The Agency of Human Services shall seek the appropriate federal approvals, waivers, exemptions, or agreements, or a combination thereof, as needed to enable all covered entities enrolled in or eligible for the federal 340B Drug Pricing Program to participate in the State’s wholesale prescription drug importation program to the fullest extent possible without jeopardizing their eligibility for the 340B Program. (Added 2017, No. 133 (Adj. Sess.), § 1, eff. May 21, 2018; amended 2019, No. 72, § E.300.5.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4654. Program financing

§ 4654. Program financing
The Agency of Human Services shall not implement the wholesale prescription drug importation program until the General Assembly enacts legislation establishing a charge per prescription or another method of financial support for the program. (Added 2017, No. 133 (Adj. Sess.), § 1, eff. May 21, 2018.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4655. Implementation provisions

§ 4655. Implementation provisions
Upon the last to occur of the General Assembly enacting a method of financial support pursuant to section 4654 of this chapter and receipt of certification and approval by the Secretary of the U.S. Department of Health and Human Services, the Agency of Human Services shall begin implementation of the wholesale prescription drug importation program and shall begin operating the program within six months. As part of the implementation process, the Agency of Human Services shall, in accordance with State procurement and contract laws, rules, and procedures as appropriate:
(1) become licensed as a wholesaler or enter into a contract with a Vermont-licensed wholesaler;
(2) contract with one or more Vermont-licensed distributors;
(3) contract with one or more licensed and regulated Canadian suppliers;
(4) engage with health insurance plans, employers, pharmacies, health care providers, and consumers;
(5) develop a registration process for health insurance plans, pharmacies, and prescription drug-administering health care providers who are willing to participate in the program;
(6) create a publicly available source for listing the prices of imported prescription drug products that shall be made available to all participating entities and consumers;
(7) create an outreach and marketing plan to generate program awareness;
(8) starting in the weeks before the program becomes operational, create and staff a hotline to answer questions and address the needs of consumers, employers, health insurance plans, pharmacies, health care providers, and other affected sectors;
(9) establish the audit function and a two-year audit work-plan cycle; and
(10) conduct any other activities that the Agency determines to be important for successful implementation of the program. (Added 2017, No. 133 (Adj. Sess.), § 1, eff. May 21, 2018.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4656. Annual reporting

§ 4656. Annual reporting
(a) Annually on or before January 15, the Agency of Human Services shall report to the House Committees on Health Care and on Ways and Means and the Senate Committees on Health and Welfare and on Finance regarding the operation of the wholesale prescription drug importation program during the previous calendar year, including:
(1) which prescription drugs were included in the wholesale importation program;
(2) the number of participating pharmacies, health care providers, and health insurance plans;
(3) the number of prescriptions dispensed through the program;
(4) the estimated savings to consumers, health plans, employers, and the State during the previous calendar year and to date;
(5) information regarding implementation of the audit plan and audit findings; and
(6) any other information the Secretary of Human Services deems relevant.
(b) The provisions of 2 V.S.A. § 20(d) (expiration of required reports) shall not apply to the report to be made under this section. (Added 2017, No. 133 (Adj. Sess.), § 1, eff. May 21, 2018.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4671. Creation of program

§ 4671. Creation of program
The Agency of Human Services may contract or enter into agreements with qualified entities as needed to create and administer an unused drug repository program for the collection and distribution of unused drugs in Vermont, to the extent that funds are appropriated or otherwise made available for this purpose. (Added 2023, No. 61, § 1, eff. July 1, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4672. Agency of Human Services; rulemaking

§ 4672. Agency of Human Services; rulemaking
The Agency of Human Services shall adopt rules for the administration of the program, including rules regarding:
(1) donations to the program, which may include donations from institutional settings in Vermont, such as pharmacies, long-term care facilities, Veterans’ Administration facilities, correctional facilities, hospitals, and other facilities, as well as donations from individuals;
(2) what types of drugs may be donated to the program;
(3) safety criteria for donated drugs, which may include packaging requirements and inspections; and
(4) patient eligibility to receive drugs from the program, which shall be available to any patient, with priority given to patients who meet one or more of the following criteria:
(A) patients whose household income is below 400 percent of the federal poverty level;
(B) patients who are uninsured;
(C) patients who are underinsured;
(D) patients who are Medicare beneficiaries and are experiencing a coverage gap in their Medicare prescription drug coverage; and
(E) patients who are on a high-deductible health plan or on a plan with high co-payment requirements for prescription drugs, or both. (Added 2023, No. 61, § 1, eff. July 1, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 91 - Prescription Drug Cost Containment › § 4673. Limitations on liability

§ 4673. Limitations on liability
Except in cases of bad faith, gross negligence, intentional misconduct, or noncompliance with the rules adopted pursuant to section 4672 of this chapter, the following persons shall not be subject to civil or criminal liability or professional disciplinary action for participating in or otherwise complying with the program established by this subchapter or rules adopted pursuant to this subchapter:
(1) a person who donates or gives drugs to an eligible recipient, including a drug manufacturer; wholesaler; reverse distributor pharmacy; third-party logistics provider; governmental entity; hospital or other health care facility, as defined in section 9432 of this title; or long-term care facility licensed under 33 V.S.A. chapter 71;
(2) an eligible recipient, as defined by the Agency by rule pursuant to subdivision 4672(4) of this chapter;
(3) a health care provider, as defined in section 9402 of this title, who prescribes or dispenses a donated drug;
(4) an intermediary that helps administer the program by facilitating the donation or transfer of drugs to eligible recipients;
(5) a manufacturer or repackager of a donated drug; and
(6) any employee, volunteer, trainee, or other staff of any person listed in subdivisions (1)–(5) of this section. (Added 2023, No. 61, § 1, eff. July 1, 2023.)