P CHAPTER 517

An Act to amend the Code of Virginia by adding in Title 8 thereof a new
chapter numbered 28.1, consisting of sections numbered $8-646.1
through 8-646.17, inclusive, to regulate manufacture, sale and distrib-
uting of animal remedies; to impose certain duties and confer certain
powers on the Commissioner of Agriculture; to provide for collec-
tion of certain fees; and to prescribe penalties’ for violations; and
to repeal §§ 3-642 through 8-646, inclusive, of the Code of Virginia,
relating to condimental stock and poultry feeds. 8 282]

Approved March 30, 1956

Be it enacted by the General Assembly of Virginia:
1. That the Code of Virginia be amended by adding in Title 3 thereof
a new chapter numbered 23.1, consisting of sections numbered 3-646.1
through 3-646.17, inclusive, as follows:

Chapter 23.1

§ 8-646.1. As used in this chapter the following terms shall have
the meanings respectively ascribed to them.

(a) “Person” includes any individual, firm, partnership, corporation,
association, or organized group of persons whether incorporated or not.

) “Animal” means any animate being, which is not human, en-
dowed with the power of voluntary action.

(c) “Animal remedies” means all drugs, combinations of drugs, pro-
prietary medicines, and combinations of drugs and other ingredients, other
than for food purposes or cosmetic purposes, which are prepared or com-
pounded for animal use; except those exempted by the Commissioner.

(d) “Drug” means:

(1) Articles recognized in the Official United States Pharmacopoeia,
the official Homeopathic Pharmacopoeia of the United States, Official
National Formulary, or any supplement to any of them.

(2) Articles intended for use in the diagnosis, cure, mitigation, treat-
ment or prevention of disease in animals.

(3) Articles (other than food or cosmetics) intended to affect the
structure or any function of the body of animals.

. (4) Articles intended for use as a component of any articles specified
in subparagraphs (1) or (2) of this paragraph.

(e) “Label” means a display of written, printed, or graphic matter
upon the immediate container of any article; and a requirement made
under authority of this chapter that any word, statement, or other infor-
mation appearing on the label is not complied with unless such word,
statement or other information also appears on the outside container or
wrapper, of the retail package of such article, or is easily legible through
the outside container or wrapper.

' (f) “Labeling” means all labels and other written, printed, or graphic
matter
(1) Upon any article or any of its containers or wrappers;

(2) Accompanying such article at any time.

(g) “Dosage Form” means any animal remedy prepared in tablet,
pills, capsules, ampules, or other units suitable for administration as an
animal remedy.

(h) “Advertisement” means all representations, other than those on
the label, disseminated in any manner or by any means, relating to animal
remedies as defined in this chapter.

(i) “Commissioner” means Commissioner of Agriculture and Immi-
gration of the Commonwealth of Virginia. The Commissioner shall ad-
minister this chapter, which shall be known as the “Virginia Animal
Remedies Law of 1956”. All authority vested in the Commissioner by
virtue of the provisions of this chapter may with like force and effect
be executed by such employees of the Department of Agriculture and Im-
migration as the Commissioner may from time to time designate for said
purpose.

at ) “Board” means the Virginia Board of Agriculture and Immi-
gration.

(k) “Medicated feed” means a product obtained by mixing a com-
mercial feed and a drug, and is subject to all provisions of this chapter,
except as otherwise determined by the Commissioner as provided in
§ 3-646.5 (e).

(1) A word importing the singular number only may extend and be
applied to several persons or things, as well as to one person or thing;
and a word importing the plural number only may extend and be applied
to one person or thing, as well as to several persons or things.

(m) “Sell” or “sale” includes exchange.

§ 3-646.2. An animal remedy is adulterated:

(a) If it was prepared, ‘or held under unsanitary conditions whereby
it may have become contaminated with filth, or whereby it may have been
rendered injurious to animal health.

(b) If its composition, purity, strength, or quality falls belows or
differs from that which it is purported or is represented to possess by
its labeling; but, the Commissioner shall allow a reasonable tolerance from
such representation as is in accordance with good manufacturing practices.

(c) If it consists in whole or in part of any filthy, putrid or decom-
posed substance.

(d) If it bears or contains any poisonous or deleterious substance
which may render it injurious to health under such conditions of use as
are customary or usual.

(e) If its container is composed of any injurious or deleterious sub-
stance which may render it injurious to health.

§ 3-646.3. An animal remedy is misbranded:

(a) Unless the label bears:

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

. w The name, brand, or trade-mark under which the animal remedy
is sold.

(3) An accurate statement of the minimum net contents of the pack-
age, 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.

(4) 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.

(5) Adequate directions for use.

(6) 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, ad-
ministration, or application, in such manner and form, as are necessary for
the protection of animals.

(b) If the labeling is false or misleading in any particular.

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

(d) 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. :

(e) If any word, statement, or other information required to appear
on the label is not prominently placed on such label with such conspicuous-
ness, 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.

Any animal remedy that is manufactured and distributed under li-
cense from and under the supervision of the U. S. Department of Agri-
culture, and in compliance with the regulations of such department complies
with this section.

§ 3-646.4. The Commissioner shall cause animal remedies, which are
found or believed not to comply with §§ 3-646.1 through 3-646.14, inclusive,
to be withheld from sale pending compliance with such sections.

(a) 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 the court. Any
such article may be removed from display by the manufacturer or vendor,
but must be left on the premises.

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

(c) If the court finds that a detained animal remedy is adulterated or
misbranded, such article shall, after entry of the decree, be destroyed at the
expense of the defendant, under the supervision of the Commissioner; all
court costs and fees, and storage and other proper expenses, shall be levied
against the defendant or his agent. .

(d) If the adulteration or misbranding can be corrected by proper
processing or labeling of the article, the 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 ex-
ecuted, 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 §§ 3-646.1 through 3-646.14
inclusive, and that expenses incident to such proceeding were paid.

§ 3-646.5. All animal remedies offered for sale in Virginia shall be
registered by the manufacturer or person responsible for placing such
animal remedy on the market.

(a) Any person may make application for registration of any animal
remedy by filing with the Commissioner, on forms furnished by him, a state-
ment with respect to such animal remedy setting forth:

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

(2) The name, brand, or trade-mark under which the animal remedy
will be sold.

(b) A label for any. animal remedy shall accompany each application
for registration, and, when requested by the Commissioner a representa-
tive and true sample or specimen of each animal remedy to be registered
shall accompany such application. A statement of claims made or to be
made which differ from the label submitted shall be filed with the Com-
missioner prior to use.

(c) If the Commissioner, after examination and investigation, finds
that the application and labeling comply with §§ 3-646.1 through 3-646.14,
inclusive, a certificate of registration shall be issued to the applicant on pay-
ment of an inspection fee as provided in § 3-616.12. All such certificates
shall be issued for a period not exceeding one year, expiring the thirty-first
day of December of each year; but no such certificate is a recommendation
or indorsement of the animal remedy registered.

(d) 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”.

(e) The Commissioner may determine whether a preparation intended
for animal use and subject to registration shall be registered as a com-
mercial feed and/or as an animal remedy.

(f) The manufacturer or person responsible for placing on the market
an animal remedy which is offered for sale, sold or otherwise distributed
in this State before it has been properly registered shall be subject to a
penalty of twenty-five dollars payable to the Commissioner, who _ shall
deposit the same in the State treasury to the credit of the Literary Fund.
This penalty shall be paid before the animal remedy is registered.

§ 3-646.6. The Commissioner shall make all necessary investigations
pertinent to the enforcement of §§ 3-646.1 to 3-646.14, inclusive.

The Commissioner shall have free access at all reasonable 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 such sections 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 make an
examination or analysis of such sample to determine whether such sections
are being violated.

§ 3-646.7. 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 for the correcting,
alleviating, or mitigating animal injuries or diseases for which it is in-
tended, or suspend or revoke any registration for flagrant violation of
$§ 3-646.1 to 3-646.14 inclusive.

§ 3-646.8. No person shall:

(a) Sell, deliver, hold, or offer for sale any animal remedy which has
not been registered with the Commissioner as provided in § 3-646.5, 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. Depart-
ment of Agriculture, shall not be considered'as being subject to the regis-
tration requirements of such section.

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

(c) Compound, manufacture, make, produce, pack, package, or prepare
within this State 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 super-
vision of a licensed veterinarian, a graduate chemist, a licensed pharmacist,
a licensed physician, or some other person as may be approved by the Com-
missioner 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.

(d) Disseminate any advertisement which is false or misleading in any
respect, but no person or medium for the dissemination of any advertise-
ment, except the manufacturer, packer, distributor, or seller of the article
to which a false advertisement relates, is subject to the penalties for
violations of §§ 3-646.1 to 3-646.14 inclusive, by reason of the dissemination
by him of 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 which caused him to disseminate
such advertisement.

(e) Refuse to permit entry or inspection, or to permit the acquisition
of a sample or specimen of an animal remedy, as authorized by § 8-646.6.

(f) Dispose of a detained article in violation of § 3-646.4.

(g) Give a guaranty which is false, except a person who relied on a
guaranty to the same effect signed by, and containing the name and ad-
dress of, the person from whom he received the anima] remedy in good faith.

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

(i) Forge, counterfeit, simulate, or falsely represent, or without proper
authority use, any mark, stamp, tag, label, or other identification device
required by § 3-646.3.

(j) Sell or offer to sell any biological product for use on any livestock,
poultry, or other animal, unless such product is manufactured under a li-
cense 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.”

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

The Commissioner or any employee of the Department of Agriculture
and Immigration shall not use or reveal information acquired under §§
3-646.5 and 3-646.6 except in the enforcement of this chapter, or to the
courts, when relevant in any judicial proceeding.

§ 3-646.9. The Commissioner shall enforce this chapter, and the
Board may promulgate and adopt such reasonable rules and regulations as
are neceessary.

§ 3-646.10. 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 such data on their production and use as he may
consider advisable, and a report of the results of the analyses of official
samples of animal remedies sold within the State as compared with the
analyses guaranteed in the registration and on the label; provided, how-
CH. 517] ACTS OF ASSEMBLY 735

ever, that the information concerning production and use of animal reme-
dies shall not disclose the operations of any person.

§ 3-646.11. §§ 3-646.1 to 3-646.14, inclusive, do not apply to or inter-
fere with the compounding or dispensing of veterinarians’ prescriptions,
nor the dispensing of drugs or preparations by registered pharmacists com-
pounded at the request of the purchaser and not intended for resale, nor
shall such sections apply to any animal remedy sold exclusively to or used
exclusively by licensed veterinarians.

§ 3-646.12. The Commissioner shall, before issuing a certificate of
registration for any animal remedy, collect from the applicant for such
certificate, an inspection fee of twenty dollars for each separate article
registered. When an animal remedy has been registered and the inspection
fee paid by the manufacturer or distributor no other person shall be re-
quired to pay such fee.

Registration of any animal remedy may be continued in force upon the
payment of an annual inspection fee of twenty dollars for each separate
product registered. Such renewal of registration must be applied for and
all inspection fees paid on or before the thirty-first day of December of
each year.

Registration must be applied for and all inspection fees paid prior to
distributing an animal remedy in the State.

Any retailer of animal remedies who has bought a supply of such
remedies at a time, as shown by invoice dates, when such remedies were
registered, may sell or otherwise dispose of such remedies without rereg-
istering them.

3-646.13. All funds collected by the Department of Agriculture and
Immigration under this chapter except under § 3-646.5 shall be paid into
the State Treasury to the credit of the general fund.

§ 3-646.14. The Commissioner shall report violations of this chapter,
to the proper prosecuting authorities.

Each attorney for the Commonwealth to whom the Commissioner
reports any violation of such sections, shall institute appropriate proceed-
ings in any court of competent jurisdiction without delay. Before any
such violation is reported to any such attorney for the institution of
criminal proceedings, the person against whom the proceeding is con-
templated shall be given appropriate notice and an opportunity to present
his views before the Commissioner either orally or in writing, in person
or by attorney, with regard to such contemplated proceeding.

This section shall not require the Commissioner to report, for the insti-
tution of prosecution under such sections, minor violations of this chapter
if he believes the public interest will be adequately served in the circum-
stances 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
Commissioner or 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.

8-646.15. Any person convicted of violating any provision of this
chapter or the rules and regulations issued thereunder shall be adjudged
guilty of a misdemeanor.

§ 8-646.16. If any provision of this chapter is declared unconstitu-
tional or the applicability thereof to any person or circumstance is held
invalid, the constitutionality of the remainder of this chapter and the ap-
plicability thereof to other persons and circumstances shall not be affected
thereby.

§ 3-646.17. All laws and parts of laws in conflict with or inconsistent
with the provisions of this chapter are hereby repealed.
if 3-642 through 3-646, inclusive, of the Code of Virginia are re-
pealed.
3. This act shall be effective January one, nineteen hundred fifty-seven.