Code of Virginia

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Code of Virginia
Title 3.2. Agriculture, Animal Care, and Food
Subtitle III. Production and Sale of Agricultural Products
Chapter 49. Animal Remedies

Chapter 49. Animal Remedies.

§ 3.2-4900. Definitions.

As used in this chapter, unless the context requires a different meaning:

"Advertisement" means all representations, other than those on the label, disseminated in any manner or by any means, relating to animal remedies.

"Animal" means any animate being, which is not human, endowed with the power of voluntary action.

"Animal remedies" means all drugs, combinations of drugs, proprietary medicines, and combinations of drugs and other ingredients, other than for food purposes or cosmetic purposes that are prepared or compounded for animal use; except those exempted by the Commissioner.

"Dosage form" means any animal remedy prepared in tablets, pills, capsules, ampules, or other units suitable for administration as an animal remedy.

"Drug" means articles: (i) recognized in the latest addition or any supplement thereto of the Official United States Pharmacopoeia, the official Homeopathic Pharmacopoeia of the United States, or the Official National Formulary; (ii) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals; (iii) other than food or cosmetics, intended to affect the structure or any function of the body of animals; or (iv) intended for use as a component of any articles specified in clauses (i) or (ii) of this definition.

"Label" means a display of written, printed, or graphic matter upon the immediate container of any article.

"Labeling" means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers or accompanying such article.

"Medicated feed" means a product obtained by mixing a commercial feed and a drug.

"Quantity statement" means the net weight (mass), net volume (liquid or dry), count or other form of measurement of a commodity.

"Sell" or "sale" includes exchange.

"Stop sale, use, removal, or seizure order" means an order that prohibits the distributor from selling, relocating, using, or disposing of an animal remedy in any manner, until the Commissioner or an appropriate gives written permission to sell, relocate, use or dispose of the animal remedy.

Code 1950, § 3-646.1; 1956, c. 517; 1966, c. 702, § 3.1-829; 1994, c. 910; 2008, c. 860.

§ 3.2-4901. Exemptions from chapter.

The provisions of this chapter shall not apply to:

1. The compounding or dispensing of veterinarians' prescriptions, nor the dispensing of drugs or preparations by registered pharmacists compounded at the request of the purchaser and not intended for resale, nor shall such provisions apply to any animal remedy sold exclusively to or used exclusively by licensed veterinarians.

2. Any animal remedy that contains as an ingredient any part of the Cannabis plant or any product made from any part of the Cannabis plant.

Code 1950, § 3-646.11; 1956, c. 517; 1966, c. 702, § 3.1-841; 2008, c. 860; 2019, c. 267.

§ 3.2-4902. Registration required.

A. The manufacturer or person responsible for distributing an animal remedy in the Commonwealth shall obtain a registration from the Commissioner for the animal remedy before placing such remedy on the market, except for medicated feeds registered under subsection C of § 3.2-4804 of the Virginia Commercial Feed Law.

B. Any person may make application for registration of any animal remedy by filing with the Commissioner, on forms furnished or approved by him, a statement with respect to such animal remedy that includes:

1. The name and principal address of the manufacturer or person responsible for placing such animal remedy on the market and the name and address of the person to whom correspondence should be directed; and

2. The name, brand, or trademark under which the animal remedy will be sold.

C. A label for any animal remedy shall accompany each application for registration, and, when requested by the Commissioner, a representative and true sample or specimen of each animal remedy to be registered shall accompany such application.

D. A statement of claims made or to be made that differ from the label submitted shall be filed with the Commissioner prior to use.

E. If the Commissioner after examination and investigation, finds that the application and labeling comply with the provisions of this chapter, a certificate of registration shall be issued to the applicant on payment of a registration fee as provided in § 3.2-4904.

F. This section does not apply to an animal remedy intended solely for investigational, experimental, or laboratory use by qualified persons, provided such remedy is plainly labeled "for investigational use only."

G. The Commissioner may determine whether a preparation intended for animal use and subject to registration shall be registered as a commercial feed and as an animal remedy.

H. The manufacturer or person responsible for placing on the market an animal remedy that is offered for sale, sold or otherwise distributed in the Commonwealth before it has been properly registered shall be subject to a late registration fee of $50 payable to the Commissioner in addition to the registration fee. The registrant shall pay the late registration fee before the registration is issued.

Code 1950, § 3-646.5; 1956, c. 517; 1966, c. 702, § 3.1-834; 1994, c. 910; 2008, c. 860.

§ 3.2-4903. Refusal or revocation of registration.

The Commissioner may refuse to issue any certificate of registration to any applicant, if available facts indicate that the product proposed for registration is of negligible or no value in correcting, alleviating, or mitigating animal injuries or diseases for which it is intended. The Commissioner may suspend or revoke any registration for violation of any provision of this chapter.

Code 1950, § 3-646.7; 1956, c. 517; 1966, c. 702, § 3.1-836; 2008, c. 860.

§ 3.2-4904. Registration fees; terms of registration; renewal of registration.

A. The Commissioner shall, before issuing a certificate of registration for any animal remedy, collect from the applicant for such certificate a registration fee of $25 for each separate animal remedy registered. When an animal remedy has been registered and the registration fee paid by the manufacturer or distributor, no other person shall be required to pay such fee.

B. The registrant shall pay a registration fee for the registration year of January 1 through December 31. Each registration shall expire on December 31 of the year for which it is issued. A registration is valid through January 31 of the next ensuing year or until the issuance of the renewal registration, whichever event occurs first, so long as the holder of the registration has filed a renewal application with the Commissioner on or before December 31 of the year for which the current registration was issued and has paid the registration fee to the Commissioner. The granting of registration does not constitute the Commissioner's recommendation or endorsement of the animal remedy.

C. If the Commissioner identifies any unregistered animal remedy in commerce in the Commonwealth during the registration year, the Commissioner shall give the person who is required to register the animal remedy, a grace period of 15 working days from issuance of notification to register the animal remedy. Any person required to register an animal remedy who fails to register the animal remedy within the grace period shall pay to the Commissioner a $50 late fee in addition to the registration fee. The Commissioner may issue a stop sale, use, removal, or seizure order upon any animal remedy until the registration is issued.

Code 1950, § 3-646.12; 1956, c. 517; 1966, c. 702, § 3.1-842; 1994, c. 910; 2008, c. 860.

§ 3.2-4905. Disposition of funds collected.

All fees and assessments received by the Commissioner under this chapter shall be paid into the Feed, Lime, Fertilizer and Animal Remedies Fund, established in § 3.2-3617, to be used in carrying out the provisions of this chapter.

Code 1950, § 3-646.13; 1956, c. 517; 1966, c. 702, § 3.1-843; 1994, c. 910; 2008, c. 860.

§ 3.2-4906. Adulterated remedy.

An animal remedy is adulterated if:

1. It was prepared or held under unsanitary conditions and as a result it: (i) may have become contaminated with filth; or (ii) may have been rendered injurious to animal health.

2. Its composition, purity, strength, or quality falls below or differs from what it is purported or is represented to possess by its labeling. The Commissioner shall allow a reasonable tolerance from such representation, in accordance with good manufacturing practices.

3. It consists in whole or in part of any filthy, putrid or decomposed substance.

4. It bears or contains any poisonous or deleterious substance that may render it injurious to health under such conditions of use as are customary or usual.

5. Its container is composed of any injurious or deleterious substance that may render it injurious to health.

Code 1950, § 3-646.2; 1956, c. 517; 1966, c. 702, § 3.1-831; 1994, c. 910; 2008, c. 860.

§ 3.2-4907. Misbranded remedy.

An animal remedy is misbranded:

1. Unless the label bears, in the English language:

a. The name and principal addresses of the manufacturer or person responsible for placing such animal remedy on the market.

b. The name, brand, or trademark under which the animal remedy is sold.

c. An accurate quantity statement of the net contents of the package, lot, or parcel, such contents stated by weight in the case of solids, by volume in the case of liquids, and by both count and weight or volume per dose in the case of dosage forms.

d. The common or usual name of each active ingredient; in the case of a drug or drugs intended to be mixed with or in a feed for animals, and in the case of mixtures of a drug or drugs with or in a feed for animals, the English name of each active ingredient shall be stated and also the percentage of each active ingredient, or, in the case of antibiotics, the number of grams of each such active ingredient present in one pound of the product.

e. Adequate directions for use.

f. Adequate warnings against use in those conditions, whether pathological or normal, where its use may be dangerous to the health of animals, or against unsafe dosage, methods or duration of methods, administration, or application, in such manner and form, as are necessary for the protection of animals.

2. If the labeling is false or misleading in any particular.

3. If its container is made, formed, or filled so as to be deceptive or misleading as to the amount of contents.

4. If it is dangerous to the health of animals when used in the dosage or with the frequency or duration prescribed, recommended, or suggested in the labeling of such remedy.

5. If any word, statement, or other information appearing on the label does not also appear on the outside container or wrapper, if present, of the retail package of such article, or is not easily legible through the outside container or wrapper.

6. If any word, statement, or other information required to appear on the label is not prominently placed on the label with such conspicuousness, as compared with other words, statements, designs, or devices in the labeling, and in such terms, that it is likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Any animal remedy that is manufactured and distributed under license from and under the supervision of the U.S. Department of Agriculture, and in compliance with the regulations of such department complies with this section.

Code 1950, §§ 3-646.1, 3-646.3; 1956, c. 517; 1966, c. 702, §§ 3.1-829, 3.1-832; 1994, c. 910; 2008, c. 860.

§ 3.2-4908. Withholding noncomplying remedies from sale; tagging, condemnation, destruction, and correction of adulterated or misbranded remedies.

A. The Commissioner shall require those animal remedies that are found or believed not to comply with the provisions of this chapter to be withheld from sale until he determines that the remedies are in compliance with such provisions.

B. Whenever the Commissioner finds or has reasonable cause to believe an animal remedy is adulterated or misbranded he shall affix to such article a tag or other appropriate marking, giving notice that such article is, or is suspected of being, adulterated or misbranded and has been detained and warning all persons not to dispose of such article in any manner until permission is given by the Commissioner or an appropriate court. Any such article may be removed from display by the manufacturer or vendor, but shall remain on the premises.

C. If such a detained article is found, after examination and analysis, to be adulterated or misbranded, the Commissioner may petition the judge of any appropriate court in whose jurisdiction the article is detained for condemnation. If the Commissioner finds that such detained article is not adulterated or misbranded, he shall remove the tag or other marking.

D. If the court finds that a detained animal remedy is adulterated or misbranded, such article shall, after entry of the decree, be destroyed, under the supervision of the Commissioner, at the expense of the defendant. All court costs and fees, and storage and other proper expenses, shall be paid by the defendant or his agent.

E. If the adulteration or misbranding can be corrected by proper processing or labeling of the article, an appropriate court, after entry of the decree and after such costs, fees, and expenses have been paid and a sufficient bond, conditioned that such article shall be so processed or labeled, has been executed, may order such article to be delivered to the defendant for such processing or labeling under the supervision of the Commissioner. The expense of such supervision shall be paid by the defendant. The bond shall be returned to the defendant on the representation to the court by the Commissioner that the article no longer violates any of the provisions of this chapter and that expenses incident to such proceeding were paid.

Code 1950, § 3-646.4; 1956, c. 517; 1966, c. 702, § 3.1-833; 1994, c. 910; 2008, c. 860.

§ 3.2-4909. Investigations by Commissioner; right of access; securing and examining samples; obstructing Commissioner; penalty.

The Commissioner shall make all necessary investigations pertinent to the enforcement of this chapter.

The Commissioner shall have free access during operating hours to any establishment in which animal remedies are manufactured, processed, packed, sold or offered for sale, to inspect such premises and to determine whether the provisions of this chapter are being violated.

The Commissioner may secure samples or specimens of any animal remedy after paying or offering to pay for them, and he shall have an examination or analysis made of such sample to determine whether the provisions of this chapter are being violated. Any person who hinders or obstructs in any way the Commissioner in the performance of his official duties is guilty of a Class 3 misdemeanor.

Code 1950, § 3-646.6; 1956, c. 517; 1966, c. 702, § 3.1-835; 1972, c. 741; 1994, c. 910; 2008, c. 860.

§ 3.2-4910. Use of information acquired by Commissioner or employees of Department.

The Commissioner or any employee of the Department shall not use or reveal information acquired under §§ 3.2-4902 and 3.2-4909 except in the enforcement of this chapter, or to the courts, when relevant in any judicial proceeding.

Code 1950, § 3-646.8:1; 1956, c. 517; 1966, c. 702, § 3.1-838; 2008, c. 860.

§ 3.2-4911. Publication of information by Commissioner.

The Commissioner may publish at such times and in such forms as he may deem proper, information concerning the sales of animal remedies, together with data on their production and use, and a report of the results of the analyses of official samples of animal remedies sold within the Commonwealth as compared with the analyses guaranteed in the registration and on the label. The information concerning production and use of animal remedies shall not disclose the operations of any person.

Code 1950, § 3-646.10; 1956, c. 517; 1966, c. 702, § 3.1-840; 2008, c. 860.

§ 3.2-4912. Prohibitions.

A. It is unlawful for any person to:

1. Sell, deliver, hold, or offer for sale any animal remedy that has not been registered with the Commissioner as provided in § 3.2-4902, except that any biological product for use on or testing of any livestock, poultry, or any animal, manufactured under a license issued by the U.S. Department of Agriculture, shall not be considered as being subject to the registration requirements of such section.

2. Manufacture, sell, deliver, hold, or offer for sale any animal remedy that is adulterated or misbranded.

3. Compound, manufacture, make, produce, pack, package, or prepare within the Commonwealth any animal remedy to be offered for sale or distribution unless such compounding, manufacture, making, producing, packaging, packing, or preparing is done with adequate equipment under the supervision of a licensed veterinarian, a graduate chemist, a licensed pharmacist, a licensed physician, or some other person as may be approved by the Commissioner after an investigation and a determination by the Commissioner that they are qualified by scientific or technical training or by experience to perform such duties of supervision as may be necessary to protect animal health and public safety.

4. Disseminate any advertisement that is false or misleading. No person or medium for the dissemination of any advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates, is subject to the penalties for violations of this chapter for disseminating such false advertisement, unless he refused, on the request of the Commissioner, to furnish the name and address of the manufacturer, packer, distributor, seller, or advertising agency that caused him to disseminate such advertisement.

5. Dispose of a detained article in violation of § 3.2-4908.

6. Give a guaranty that is false, except a person who relied on the guaranty signed by, and containing the name and address of, the person from whom he received the animal remedy in good faith.

7. Alter, mutilate, destroy, obliterate, or remove any part of the labeling of any animal remedy if such acts result in the animal remedy being misbranded, or do any other act, while the animal remedy is being held for sale that results in the misbranding of such article.

8. Forge, counterfeit, simulate, or falsely represent, or without proper authority use, any mark, stamp, tag, label, or other identification device required by § 3.2-4907.

9. Sell or offer to sell any biological product for use on any livestock, poultry, or other animal, unless such product is manufactured under a license issued by the U.S. Department of Agriculture or a registration issued by the Commissioner, or unless such product meets the requirements of the federal Food, Drug and Cosmetic Act.

10. Sell or offer to sell any biological product that has not been kept in refrigeration under conditions prescribed by the regulations of the Board.

B. The Commissioner shall assess any person who commits a prohibited act under this chapter 10 percent of the retail price of the animal remedy at the time of sampling on the product found in violation, or $50, whichever is greater, not to exceed $5,000 per occurrence. The person assessed shall pay the assessment to the Commissioner within 60 days from the date of notice to the person whose name appears on the label. Any person who fails to pay the assessment within the specified time shall pay a late fee of $50 to the Commissioner in addition to the assessment. The Commissioner shall revoke the registration of any person who fails to pay the assessment.

Code 1950, § 3-646.8; 1956, c. 517; 1966, c. 702, § 3.1-837; 1994, c. 910; 2008, c. 860.

§ 3.2-4913. Report of violations; duty of attorney for the Commonwealth.

The Commissioner shall report violations of this chapter to the attorney for the Commonwealth. It shall be the duty of every attorney for the Commonwealth, to whom the Commissioner shall report any violation of this chapter, to commence proceedings and prosecute without delay. This section shall not require the Commissioner to report, for the institution of prosecution under such sections, minor violations of this chapter if he believes the public interest will be adequately served in the circumstances by a suitable written notice of warning. In all prosecutions under this chapter involving the composition of an animal remedy, a certified copy of the official analysis signed by the analyst shall be accepted as prima facie evidence of the composition, provided the defendant has been furnished a copy thereof in advance of the trial.

Code 1950, § 3-646.14; 1956, c. 517; 1966, c. 702, § 3.1-844; 1972, c. 741; 1994, c. 910; 2008, c. 860.

§ 3.2-4914. Violation of chapter or regulations a misdemeanor.

Any person convicted of violating any provisions of this chapter and the regulations issued hereunder is guilty of a Class 1 misdemeanor, except as otherwise provided.

Code 1950, § 3-646.15; 1956, c. 517; 1966, c. 702, § 3.1-845; 1994, c. 910; 2008, c. 860.