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2023 Vermont Statutes › Title 18 - Health › Chapter 79 - Pharmacy Audits › § 3801. Definitions

§ 3801. Definitions
As used in this subchapter:
(1)(A) “Health insurer” shall have the same meaning as in section 9402 of this title and shall include:
(i) a health insurance company, a nonprofit hospital and medical service corporation, and health maintenance organizations;
(ii) an employer, a labor union, or another group of persons organized in Vermont that provides a health plan to beneficiaries who are employed or reside in Vermont; and
(iii) except as otherwise provided in section 3805 of this title, the State of Vermont and any agent or instrumentality of the State that offers, administers, or provides financial support to State government.
(B) The term “health insurer” shall not include Medicaid or any other Vermont public health care assistance program.
(2) “Health plan” means a health benefit plan offered, administered, or issued by a health insurer doing business in Vermont.
(3) “Pharmacy” means any individual or entity licensed or registered under 26 V.S.A. chapter 36.
(4) “Pharmacy benefit management” means an arrangement for the procurement of prescription drugs at a negotiated rate for dispensation within this State to beneficiaries, the administration or management of prescription drug benefits provided by a health plan for the benefit of beneficiaries, or any of the following services provided with regard to the administration of pharmacy benefits:
(A) mail service pharmacy;
(B) claims processing, retail network management, and payment of claims to pharmacies for prescription drugs dispensed to beneficiaries;
(C) clinical formulary development and management services;
(D) rebate contracting and administration;
(E) certain patient compliance, therapeutic intervention, and generic substitution programs; and
(F) disease or chronic care management programs.
(5) “Pharmacy benefit manager” means an entity that performs pharmacy benefit management. The term includes a person or entity in a contractual or employment relationship with an entity performing pharmacy benefit management for a health plan.
(6) “Responsible party” means the entity, including a health insurer or pharmacy benefit manager, responsible for payment of claims for health care services other than:
(A) the individual to whom the health care services were rendered;
(B) that individual’s guardian or legal representative; or
(C) the Agency of Human Services, its agents, and contractors. (Added 2011, No. 150 (Adj. Sess.), § 4; amended 2013, No. 79, § 18, eff. Jan. 1, 2014.)
2023 Vermont Statutes › Title 18 - Health › Chapter 79 - Pharmacy Audits › § 3803. Appeals

§ 3803. Appeals
(a) An entity that audits a pharmacy shall provide the pharmacy with a preliminary audit report, which shall be delivered to the pharmacy or to its corporate office of record within 60 days following completion of the audit.
(b) A pharmacy shall have 30 days following receipt of the preliminary audit report in which to respond to questions, provide additional documentation, and comment on and clarify audit findings. Receipt of the report shall be based on the date postmarked on the envelope or the date of a computer transmission, if transferred electronically.
(c) If an audit results in the dispute or denial of a claim, the entity conducting the audit shall allow the pharmacy to resubmit the claim using any commercially reasonable method, including U.S. mail, facsimile, or electronic claims submission, as long as the period of time during which a claim may be resubmitted has not expired.
(d) Within 120 days after the completion of the appeals process established by this section, a final audit report shall be delivered to the pharmacy or to its corporate office of record. The final audit report shall include a disclosure of any funds recovered by the entity that conducted the audit.
(e) An entity that audits a pharmacy shall have in place a written appeals process by which a pharmacy may appeal the preliminary audit report and the final audit report, and shall provide the pharmacy with notice of the appeals process.
(f) A pharmacy shall be entitled to request a mediator agreed upon by both parties to resolve any disagreements; such request shall not be deemed to waive any existing rights of appeal. (Added 2011, No. 150 (Adj. Sess.), § 4.)
2023 Vermont Statutes › Title 18 - Health › Chapter 79 - Pharmacy Audits › § 3804. Pharmacy audit recoupments

§ 3804. Pharmacy audit recoupments
(a) Recoupment of any disputed funds shall occur only after the final internal disposition of an audit, including the appeals process set forth in section 3803 of this title.
(b) An entity conducting an audit may not:
(1) include dispensing fees in calculations of overpayments unless the prescription is determined to have been dispensed in error;
(2) recoup funds for clerical or recordkeeping errors, including typographical errors, scriveners’ errors, and computer errors on a required document or record unless the error resulted in overpayment or the entity conducting the audit has evidence that the pharmacy’s actions reasonably indicate fraud or other intentional or willful misrepresentation;
(3) collect any funds, charge-backs, or penalties until the audit and all appeals are final, unless the entity conducting the audit is alleging fraud or other intentional or willful misrepresentation;
(4) recoup an amount in excess of the actual overpayment.
(c) Recoupment on an audit shall be refunded to the responsible party as contractually agreed upon by the parties.
(d) The entity conducting the audit may charge or assess the responsible party, directly or indirectly, based on amounts recouped if both of the following conditions are met:
(1) the responsible party and the entity conducting the audit have entered into a contract that explicitly states the percentage charge or assessment to the responsible party; and
(2) a commission or other payment to an agent or employee of the entity conducting the audit is not based, directly or indirectly, on amounts recouped. (Added 2011, No. 150 (Adj. Sess.), § 4.)
2023 Vermont Statutes › Title 18 - Health › Chapter 79 - Pharmacy Audits › § 3805. Applicability

§ 3805. Applicability
The provisions of this chapter shall not apply to any audit or investigation undertaken by any State agency, including the Office of the Attorney General or the Agency of Human Services, to a fiscal agent of the State, or to any audit, review, or investigation that involves alleged Medicaid fraud, Medicaid waste, Medicaid abuse, insurance fraud, or criminal fraud or misrepresentation. (Added 2011, No. 150 (Adj. Sess.), § 4.)
2023 Vermont Statutes › Title 18 - Health › Chapter 81 - Pure Foods and Drugs › § 4023. Bread to be wrapped

§ 4023. Bread to be wrapped
A person shall not carry or cart about with intent to sell or offer for sale, or deliver to customers after it has been sold, for human food any kind or quality of bread or cake in loaf form, unless each loaf is wrapped separately in waxed paper, tissue paper, or some similar wrapper or a sanitary container of sufficient thickness and quality to protect the bread and cake from dust and dirt. A person who violates a provision of this section shall be fined $5.00 for each offense.
2023 Vermont Statutes › Title 18 - Health › Chapter 81 - Pure Foods and Drugs › § 4024. Wood or methyl alcohol; sale for medicinal purposes

§ 4024. Wood or methyl alcohol; sale for medicinal purposes
(a) A person shall not sell, offer, or expose for sale or have in his or her custody, possession, or control with intent to distribute or sell any commodity, food, drug, preparation, or mixture of any kind whatever intended for internal use, which contains methyl or wood alcohol, or sell, offer, or expose for sale or distribution, or have in his or her custody, possession, or control with intent to distribute, sell, furnish, or use upon or apply to the body of another, any drug, hair tonic, bay rum, or similar preparation intended for external use, which contains methyl or wood alcohol. Nothing in this section shall apply to veterinary remedies containing methyl or wood alcohol when such remedies are plainly and distinctly labeled in such manner as to indicate that they are intended solely for external use on animals.
(b) A person who violates a provision of this section shall be imprisoned not more than three months or fined not more than $100.00 nor less than $5.00, or both. (Amended 1981, No. 223 (Adj. Sess.), § 23.)
2023 Vermont Statutes › Title 18 - Health › Chapter 81 - Pure Foods and Drugs › § 4025. Regulation of the sale of poisonous drugs

§ 4025. Regulation of the sale of poisonous drugs
A person other than a registered pharmacist or physician who sells or keeps for sale arsenic, corrosive sublimate, chloroform, aconite, strychnine, morphine, opium, cocaine, eucaine, heroin, carbolic acid, prussic acid, paregoric, chloral hydrate, belladonna, cyanide potassium, digitalis, nux vomica, or any salts, solutions, extracts, or tinctures of such drugs, shall keep and offer them for sale only in original and sealed packages or bottles that shall have been prepared by a registered pharmacist or manufacturing chemist, and under a label on which shall be plainly printed the name and nature of the drug therein contained, the proper antidote to be given when taken in dangerous or poisonous quantities, and the name of the pharmacist, manufacturing chemist, or wholesale house that prepared or put up the same, with the name of the place where it was manufactured or prepared for sale. A person who sells any of such drugs shall have affixed to the bottle, box, or wrapper containing the article sold a label of white paper upon which shall be printed in red letters the name and place of business of the vendor, and the words “Poison” and “Antidote.” The label shall also contain the name of an antidote, if any, for the poison sold.
2023 Vermont Statutes › Title 18 - Health › Chapter 81 - Pure Foods and Drugs › § 4026. Sale of drugs; record

§ 4026. Sale of drugs; record
When a sale is made by any person of any of such drugs, salts, solutions, extracts, or tinctures, such sale shall be entered and recorded in a book kept for that purpose, giving the name of the article sold, date of sale, to whom sold, residence of purchaser, for whom purchased, the use to be made of the article or drug purchased, and the name of the salesperson or clerk making such sale. Such book shall be in such form as the Commissioner shall prescribe and shall be open to the inspection of health officers, Commissioner, and prosecuting officers who may wish to examine the same. The provisions of this section shall not apply to compounds or preparations labeled according to other provisions of this chapter. (Amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 53, § 79, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 81 - Pure Foods and Drugs › § 4029. Permit to use preservatives

§ 4029. Permit to use preservatives
Nothing in this title shall be so construed as to prevent the Commissioner from issuing to a producer or manufacturer of food or drinks a permit to use such preservatives or coloring matters as the Commissioner may determine are not detrimental to health. (Amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 53, § 80, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 81 - Pure Foods and Drugs › § 4030. Embargo; penalty

§ 4030. Embargo; penalty
When it is found or there is probable cause to believe that an article of food or a drug is in violation of the provisions of this title, the Commissioner or Commissioner’s authorized representative may embargo the distribution, sale, use, or transportation of such article until directions for its disposal shall be given by the Commissioner or by action of court. A person, partnership, or corporation that moves, sells, or otherwise disposes of any article so embargoed shall be punished as provided in section 6 of this title. (Amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 53, § 81, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 81 - Pure Foods and Drugs › § 4031. Notice of violations of U.S. statutes

§ 4031. Notice of violations of U.S. statutes
The Commissioner or the Commissioner’s designated agent shall notify the proper prosecuting officer of a violation of a federal law for preventing the adulteration or misbranding of food or drugs. (Amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2017, No. 113 (Adj. Sess.), § 70; 2023, No. 53, § 82, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4052. Manufacture, sale, delivery; prohibitions

§ 4052. Manufacture, sale, delivery; prohibitions
The following acts and the causing thereof within the State of Vermont are hereby prohibited:
(1) the manufacture, sale, or delivery, holding, or offering for sale of any food, drug, device, or cosmetic that is adulterated or misbranded;
(2) the adulteration or misbranding of any food, drug, device, or cosmetic;
(3) the receipt in commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise;
(4) the sale, delivery for sale, holding for sale, or offering for sale of any article in violation of section 4061 or 4065 of this title;
(5) the dissemination of any false advertisement;
(6) the refusal to permit entry or inspection, or to permit the taking of a sample, as authorized by section 4070 of this title;
(7) the giving of a guaranty or undertaking which guaranty or undertaking is false, except by a person who relied on a guaranty or undertaking to the same effect signed by and containing the name and address of the person residing in the State of Vermont from whom he or she received in good faith the food, drug, device, or cosmetic;
(8) the removal or disposal of a detained or embargoed article in violation of section 4055 of this title;
(9) the alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to a food, drug, device, or cosmetic, if such act is done while such article is held for sale and results in such article being adulterated or misbranded;
(10) forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by rules adopted under the provisions of this chapter;
(11) the using, on the labeling of any drug or in any advertisement relating to such drug, of any representation or suggestion that any application with respect to such drug is effective under section 4065 of this title, or that such drug complies with the provisions of such section;
(12) the sale, offering for sale, distribution, or transportation for sale within this State of any misbranded package of a hazardous substance in a package or container intended for general home and household use. (Added 1959, No. 172, § 3, eff. May 12, 1959; amended 2017, No. 113 (Adj. Sess.), § 72; 2023, No. 6, § 138, eff. July 1, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4054. Penalties

§ 4054. Penalties
(a) A person who violates any of the provisions of section 4052 of this title shall be imprisoned for not more than one year or fined not more than $1,000.00, or both; but if the violation is committed after a conviction of the person under this section has become final, the person shall be imprisoned for not more than one year or fined not more than $2,500.00, or both.
(b) A person shall not be subject to the penalties of subsection (a) of this section for having violated subdivision 4052(1) or (3) of this title if he or she establishes a guaranty or undertaking signed by and containing the name and address of the person residing in the State of Vermont from whom he or she received in good faith the article, to the effect that the article is not adulterated or misbranded within the meaning of this chapter, designating this chapter.
(c) No publisher, radio broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates, shall be liable under this section by reason of the dissemination by the person of such false advertisement, unless the person has refused, on the request of the Commissioner, to furnish the Commissioner the name and post office address of the manufacturer, packer, distributor, seller, or advertising agency, residing in the State of Vermont, who causes the person to disseminate such advertisement. (Added 1959, No. 172, § 5, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 53, § 85, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4056. Proceedings

§ 4056. Proceedings
(a) Each State’s Attorney to whom the Commissioner reports any violation of this chapter shall cause appropriate proceedings to be instituted in the proper courts without delay and to be prosecuted in the manner required by law.
(b) Before any violation of this chapter is reported to any such attorney for the institution of a criminal proceeding, the person against whom the proceeding is contemplated shall be given appropriate notice and an opportunity to present the person’s views before the Commissioner or the Commissioner’s designated agent, either orally or in writing, in person, or by attorney, with regard to the contemplated proceedings. (Added 1959, No. 172, § 7, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2017, No. 93 (Adj. Sess.), § 16; 2023, No. 53, § 87, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4057. Construction

§ 4057. Construction
Nothing in this chapter shall require the Commissioner to report for the institution of proceedings under this chapter minor violations of this chapter whenever the Commissioner believes that the public interest will be adequately served in the circumstances by a suitable written notice of warning. (1959, No. 172, § 8, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 53, § 88, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4058. Rules; standards

§ 4058. Rules; standards
Whenever in the judgment of the Commissioner such action will promote honesty and fair dealing in the interest of consumers, the Department shall adopt rules fixing and establishing for any food or class of food a reasonable definition and standard of identity, or reasonable standard of quality or fill of container. In prescribing a definition and standard of identity for any food or class of food in which optional ingredients are permitted, the Department shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients that shall be named on the label. The definitions and standard so adopted shall conform so far as practicable to the definitions and standards promulgated under authority of the federal act. (Added 1959, No. 172, § 9, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2015, No. 23, § 109; 2023, No. 53, § 89, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4059. Adulterated food defined

§ 4059. Adulterated food defined
A food shall be deemed to be adulterated:
(1)(A) If it bears or contains any poisonous or deleterious substance that may render it injurious to health; but in case the substance is not an added substance, the food shall not be considered adulterated under this clause if the quantity of the substance in the food does not ordinarily render it injurious to health;
(B) if it bears or contains any added poisonous or added deleterious substance that is unsafe within the meaning of section 4062 of this title;
(C) if it consists in whole or in part of a diseased, contaminated, filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;
(D) if it has been produced, prepared, packed, or held under unsanitary conditions in which it may have become contaminated with filth or in which it may have been rendered diseased, unwholesome, or injurious to health;
(E) if it is the product of a diseased animal or an animal that has died otherwise than by slaughter, or that has been fed upon the uncooked offal from a slaughterhouse; or
(F) if its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health.
(2)(A) If any valuable constituent has been in whole or in part omitted or abstracted therefrom;
(B) if any substance has been substituted wholly or in part therefor;
(C) if damage or inferiority has been concealed in any manner; or
(D) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength or make it appear better or of greater value than it is.
(3) If it is confectionery and it bears or contains any alcohol or nonnutritive article or substance except harmless coloring, harmless flavoring, harmless resinous glaze not in excess of four-tenths of one percent, harmless natural wax not in excess of four-tenths of one percent, harmless natural gum and pectin; provided that this subdivision shall not apply to any confectionery by reason of its containing less than one-half of one percent by volume of alcohol derived solely from the use of flavoring, extracts, or to any chewing gum by reason of its containing harmless nonnutritive masticatory substances.
(4) If it bears or contains a coal tar color other than one from a batch that has been certified under authority of the federal act. (Added 1959, No. 172, § 10, eff. May 12, 1959; amended 2023, No. 6, § 140, eff. July 1, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4061. Rules regarding permits; investigation

§ 4061. Rules regarding permits; investigation
(a) Whenever the Department finds after investigation that the distribution in Vermont of any class of food may, by reason of contamination with microorganisms during manufacture, processing, or packing thereof in any locality, be injurious to health, and that the injurious nature cannot be adequately determined after the articles have entered commerce, it then, and in that case only, shall adopt rules providing for the issuance to manufacturers, processors, or packers of that class of food in that locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of that class of food and for such temporary period of time, as may be necessary to protect the public health, and after the effective date of the rules and during the temporary period, no person shall introduce or deliver for introduction into commerce any such food manufactured, processed, or packed by any such manufacturer, processor, or packer unless the manufacturer, processor, or packer holds a permit issued by the Department as provided by the rules.
(b) The Department is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated. The holder of a permit so suspended shall be privileged at any time to apply for the reinstatement of the permit and the Department shall, immediately after prompt hearing and inspection of the establishment, reinstate the permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued, or as amended.
(c) Any officer or employee duly designated by the Department shall have access to any factory or establishment, the operator of which holds a permit from the Department, for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for the inspection shall be grounds for suspension of the permit until the access is freely given by the operator. (Added 1959, No. 172, § 12, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2015, No. 23, § 110; 2023, No. 6, § 141, eff. July 1, 2023; 2023, No. 53, § 91, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4062. Substances added to food; rules

§ 4062. Substances added to food; rules
Any poisonous or deleterious substance added to any food except where the substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of subdivision 4059(1)(B) of this title, but when the substance is so required or cannot be so avoided, the Department shall adopt rules limiting the quantity therein or thereon to such extent as the Department finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of subdivision 4059(1)(B) of this title. While such a rule is in effect limiting the quantity of any such substance in the case of any food, the food shall not, by reason of bearing or containing any added amount of the substance, be considered to be adulterated within the meaning of subdivision 4059(1)(A) of this title. In determining the quantity of the added substance to be tolerated in or on different articles of food, the Department shall take into account the extent to which the use of the substance is required or cannot be avoided in the production of each such article and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances. (Added 1959, No. 172, § 13, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2015, No. 23, § 111; 2023, No. 53, § 92, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4063. Adulterated drug or device defined

§ 4063. Adulterated drug or device defined
A drug or device shall be deemed to be adulterated:
(1)(A) If it consists in whole or in part of any filthy, putrid, or decomposed substance;
(B) if it has been produced, prepared, packed, or held under unsanitary conditions in which it may have been contaminated with filth or in which it may have been rendered injurious to health;
(C) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health; or
(D) if it is a drug and it bears or contains, for purposes of coloring only, a coal tar color other than one from a batch certified under the authority of the federal act.
(2) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in the compendium. The determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence of or inadequacy of the tests or methods of assay, those prescribed under authority of the federal act. No drug defined in an official compendium shall be deemed to be adulterated under this subdivision because it differs from the standard of strength, quality, or purity set forth in the compendium, if its difference in strength, quality, or purity from the standard is plainly stated on its label. Whenever a drug is recognized in both the U.S. Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the U.S. Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the U.S. Pharmacopoeia.
(3) If it is not subject to the provisions of subdivision (2) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
(4) If it is a drug and any substance has been:
(A) mixed or packed therewith so as to reduce its quality or strength; or
(B) substituted wholly or in part therefor. (Added 1959, No. 172, § 14, eff. May 12, 1959; amended 2023, No. 6, § 142, eff. July 1, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4064a. Misbranded drugs or devices sold by prescription

§ 4064a. Misbranded drugs or devices sold by prescription
(a) Except as provided in subsections (b), (c), and (d) of this section, a drug or device that is sold or offered for sale by prescription, including those transported or mailed into this State for use in this State although purchased elsewhere, is misbranded:
(1) if its labeling is false or misleading in any particular; or
(2) unless it is labeled with the following:
(A) the name of the patient or if the patient is an animal the name of its owner and the species of the animal;
(B) the expiration date of the drug where the date is required by law or has been determined by the manufacturer, Department, or any agency of the State or U.S. government, if this date is less than one year from date of dispensing;
(C) the name or place of business of the dispenser;
(D) the serial number and the date the prescription was filled;
(E) directions for use as may be stated in the prescription and the name of the medical, dental, osteopathic, or veterinary professional prescribing the drug or device;
(F) the name and strength of the drug or its generic equivalent, if any, according to the latest official U.S. Pharmacopoeia, latest official Homeopathic Pharmacopoeia of the United States, or latest official national formulary, or any supplement to any of them;
(G) the name of the drug shall be the same as written by the prescriber, unless the prescription has been filled with a generic equivalent approved by the prescriber and the purchaser has been informed of the change.
(b) The labeling requirements of subdivisions (a)(2)(F) and (G) of this section shall not apply to a drug or device if the prescribing physician explicitly requests for medical reasons that such information shall be omitted.
(c) The labeling requirements of subsection (a) of this section shall not apply to a drug or device administered under the supervision of a licensed physician to patients within a hospital or nursing home.
(d) Nothing in this section shall be construed to limit the ability of a licensed physician to give, administer, or dispense any drug or device to a patient under his or her care. (Added 1971, No. 182 (Adj. Sess.), eff. July 1, 1972; amended 2007, No. 163 (Adj. Sess.), § 4; 2023, No. 6, § 144, eff. July 1, 2023; 2023, No. 53, § 94, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4065. New drugs; sale regulations

§ 4065. New drugs; sale regulations
(a) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug unless:
(1) an application with respect thereto has become effective under section 505 of the federal act; or
(2) when not subject to the federal act, unless the drug has been tested and has not been found to be unsafe for use under the conditions prescribed, recommended, or suggested in the labeling thereof and before selling or offering the drug for sale, there has been filed with the Department an application setting forth:
(i) full reports of investigations that have been made to show whether or not the drug is safe for use;
(ii) a full list of the articles used as components of the drug;
(iii) a full statement of the composition of the drug;
(iv) a full description of the methods used in and the facilities and controls used for the manufacture, processing, and packing of the drug;
(v) such samples of the drug and of the articles used as components thereof as the Department may require; and
(vi) specimens of the labeling proposed to be used for the drug.
(b) An application provided for in subdivision (a)(2) of this section shall become effective on the 60th day after the filing thereof, except that if the Commissioner finds, after giving the applicant due notice and an opportunity for a hearing, that the drug is not safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, the Commissioner shall, before the effective date of the application, issue an order refusing to permit the application to become effective.
(c) This section shall not apply:
(1) to a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety in drugs, provided the drug is plainly labeled “for investigational use only”;
(2) to a drug sold in this State at any time before the enactment of this chapter or introduced into interstate commerce at any time before the enactment of the federal act; or
(3) to any drug that is licensed under the Virus, Serum and Toxin Act of July 1, 1902 (U.S.C. 1934 ed. title 42, chap. 4).
(d) An order refusing to permit an application under this section to become effective may be revoked by the Commissioner. (Added 1959, No. 172, § 16, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 53, § 95, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4066. Adulterated cosmetic

§ 4066. Adulterated cosmetic
A cosmetic shall be deemed to be adulterated:
(1) If it bears or contains any poisonous or deleterious substance that may render it injurious to users under the conditions of use prescribed in the labeling or advertisement thereof, or under such conditions of use as are customary or usual. Provided, that this provision shall not apply to coal tar hair dye the label of which bears the following legend conspicuously displayed thereon: “caution—this product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows, to do so may cause blindness,” and the labeling of which bears adequate directions for the preliminary testing. For the purpose of this subdivision and subdivision (5) of this section, the term “hair dye” shall not include eyelash dyes or eyebrow dyes.
(2) If it consists in whole or in part of any filthy, putrid, or decomposed substance.
(3) If it has been produced, prepared, packed, or held under unsanitary conditions in which it may have become contaminated with filth, or in which it may have been rendered injurious to health.
(4) If its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health.
(5) If it is not a hair dye and it bears or contains a coal tar color other than one from a batch that has been certified under authority of the federal act. (Added 1959, No. 172, § 17, eff. May 12, 1959; amended 2023, No. 6, § 145, eff. July 1, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4067. Misbranded cosmetic

§ 4067. Misbranded cosmetic
A cosmetic shall be deemed to be misbranded:
(1) if its labeling is false or misleading in any particular;
(2) if in package form unless it bears a label containing:
(A) the name and place of business of the manufacturer, packer, or distributor; and
(B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, provided that under this subdivision (B) reasonable variations shall be permitted and exemptions as to small packages shall be established by rules adopted by the Department;
(3) if any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(4) if its container is so made, formed, or filled as to be misleading. (Added 1959, No. 172, § 18, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 6, § 146, eff. July 1, 2023; 2023, No. 53, § 96, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4068. Advertising Rules

§ 4068. Advertising Rules
(a) An advertisement of a food, drug, device, or cosmetic shall be deemed to be false if it is false or misleading in any particular.
(b) For the purpose of this chapter, the advertisement of a drug or device representing it to have any effect in albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright’s disease, cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis (infantile paralysis), prostate gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia, or venereal disease shall also be deemed to be false, except that no advertisement, not in violation of subsection (a) of this section, shall be deemed to be false under this subsection if it is disseminated only to members of the medical, dental, or veterinary professions, or appears only in the scientific periodicals of these professions, or is disseminated only for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of the drugs or devices, provided that whenever the Department determines that an advance in medical science has made any type of self-medication safe as to any of the diseases named in this subsection, the Department shall by rule authorize the advertisement of drugs having curative or therapeutic effect for the disease, subject to such conditions and restrictions as the Department may deem necessary in the interests of public health, provided that this subsection shall not be construed as indicating that self-medication for diseases other than those named in this section is safe or efficacious. (Added 1959, No. 172, § 19, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 6, § 147, eff. July 1, 2023; 2023, No. 53, § 97, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4069. Rules; authority

§ 4069. Rules; authority
(a) The authority to adopt rules for the efficient enforcement of this chapter is hereby vested in the Department. The Department may make the rules adopted under this chapter conform, insofar as practicable, with those promulgated under the federal act.
(b) [Repealed.]
(c) Before adopting any rules contemplated by section 4058; subdivision 4060(10); section 4061; subdivisions 4064(4), (6), (7), (8), and (11); or subsection 4068(b) of this title, the Department shall give appropriate notice of the proposal and of the time and place for a hearing. The rule so adopted shall take effect on a date fixed by the Department, which date shall not be earlier than 60 days after its adoption. The rule may be amended or repealed in the same manner as is provided for its adoption, except that in the case of a rule amending or repealing any such rule, the Department, to such extent as it deems necessary in order to prevent undue hardship, may disregard the foregoing provisions regarding notice, hearing, or effective date. (Added 1959, No. 172, § 20, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2015, No. 23, § 113; 2023, No. 53, § 98, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4070. Inspection; examination of samples

§ 4070. Inspection; examination of samples
(a) The Department or its duly authorized agent shall have free access at all reasonable hours to any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held for introduction into commerce, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in commerce, for the purpose:
(1) of inspecting the factory, warehouse, establishment, or vehicle to determine if any of the provisions of this chapter are being violated; and
(2) to secure samples or specimens of any food, drug, device, or cosmetic after paying or offering to pay for the sample.
(b) It shall be the duty of the Department to make or cause to be made examinations of samples secured under the provisions of this section to determine whether any provision of this chapter is being violated. (Added 1959, No. 172, § 21, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2017, No. 113 (Adj. Sess.), § 74; 2023, No. 53, § 99, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4071. Reports

§ 4071. Reports
(a) The Commissioner may cause to be published, from time to time, reports summarizing all judgments, decrees, and court orders that have been rendered under this chapter, including the nature of the charge and the disposition thereof.
(b) The Commissioner may also cause to be disseminated such information regarding food, drugs, devices, and cosmetics as the Commissioner deems necessary in the interest of public health and the protection of the consumer against fraud. Nothing in this section shall be construed to prohibit the Department from collecting, reporting, and illustrating the results of the investigations of the Department. (Added 1959, No. 172, § 22, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 53, § 100, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4086. Menus and menu boards

§ 4086. Menus and menu boards
(a) Restaurants and similar food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items shall disclose on the menu and on the menu board:
(1) adjacent to the name of each standard menu item the number of calories contained in the item; and
(2) a succinct statement concerning suggested daily caloric intake.
(b) This section shall not apply to alcoholic beverages or to grocery stores except for separately owned food facilities to which this section otherwise applies that are located in a grocery store. For purposes of this section, grocery stores include convenience stores.
(c) If at any time subsection (a) or (b) of this section, or both, are preempted by federal law, then restaurants and similar food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items shall comply with the menu labeling provisions of the applicable federal statutes and regulations.
(d) A violation of this section shall be deemed a violation of the Consumer Protection Act, 9 V.S.A. chapter 63, provided that no private right of action shall arise from the provisions of this section. The Attorney General has the same authority to make rules, conduct civil investigations, enter into assurances of discontinuance, and bring civil actions as provided under 9 V.S.A. chapter 63, subchapter 1. (Added 2009, No. 128 (Adj. Sess.), § 38b, eff. Jan. 1, 2011; 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 84 - Possession and Control of Regulated Drugs › § 4202. Powers and duties of the Department of Health

§ 4202. Powers and duties of the Department of Health
(a) The Department of Health is authorized and empowered to adopt such rules that in its judgment may be necessary or proper to supplement the provisions of this chapter to effectuate the purposes and intent thereof or to clarify its provisions so as to provide the procedure or details to secure effective and proper enforcement of its provisions.
(b) These rules and determinations, when adopted, shall, until modified or rescinded, have the force and effect of law.
(c) The Commissioner of Health and any representative specifically authorized by the Commissioner shall have the power to administer oaths, compel the attendance of witnesses and the production of books, papers, and records, and to take proof and testimony concerning all matters with which this chapter is concerned.
(d) The rules adopted by the Department of Health under section 4201 of this title for the purpose of determining those drugs defined under that section may be adopted only after prior written notice to the Board of Pharmacy and the Board of Medical Practice and after the Board of Pharmacy and the Board of Medical Practice have had an opportunity to advise the Commissioner of Health with respect to the form and substance of those rules or amendments and to recommend revisions thereof. (Added 1967, No. 343 (Adj. Sess.), § 2, eff. March 23, 1968; amended 1971, No. 14, § 24, eff. March 11, 1971; 2013, No. 75, § 2a, eff. June 5, 2013; 2017, No. 113 (Adj. Sess.), § 76; 2023, No. 53, § 102, eff. June 8, 2023.)
2023 Vermont Statutes › Title 18 - Health › Chapter 84 - Possession and Control of Regulated Drugs › § 4203. Persons exempted

§ 4203. Persons exempted
The provisions of this chapter, restricting the possession and control of regulated drugs, shall not apply to common carriers or to warehousemen while engaged solely in lawfully transporting or storing such drugs while in their original containers, nor to any employee of the same acting within the scope of his or her employment, nor to public officers or their employees in the performance of their official duties requiring possession or control of regulated drugs, nor to temporary incidental possession by employees or agents of persons lawfully entitled to possession, including a medical or dental assistant, nurse, intern, resident, and a member of a patient’s family dispensing or administering regulated drugs under a licensed physician’s or dentist’s orders, nor by authorized persons whose possession is for the purpose of aiding public officers in performing their official duties. (Added 1967, No. 343 (Adj. Sess.), § 3, eff. March 23, 1968.)
2023 Vermont Statutes › Title 18 - Health › Chapter 84 - Possession and Control of Regulated Drugs › § 4204. Preparations excepted

§ 4204. Preparations excepted
(a) The Department of Health may provide, by rule, for the exception from all provisions of this chapter, except as provided in section 4223 of this title, of the administration, dispensation, or sale at retail of a medicinal preparation containing such amounts of one or more regulated drugs that the Department considers not subject to abuse.
(b) The exemption authorized by this section shall be subject to the condition that the medicinal preparation administered, dispensed, or sold, shall contain, in addition to the regulated drug in it, some drug or drugs conferring upon it medicinal qualities other than those possessed by the regulated drug alone, and that such preparation shall be administered, dispensed, and sold in good faith as a medicine, and not for the purpose of evading the provisions of this chapter. (Added 1967, No. 343 (Adj. Sess.), § 4, eff. March 23, 1968; amended 2017, No. 113 (Adj. Sess.), § 77; 2023, No. 53, § 103, eff. June 8, 2023.)