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Sec. 608.500 Illegal Sales of Veterinary Prescription Drugs Direct Reference Authority
for *Warning* Letter Issuance (CPG 7125.29)
BACKGROUND:
All veterinary drugs must bear adequate directions for lay use to comply with Section
502(f)(1) of the act. Since certain drugs intended for animal use are toxic or have other
potential for harmful effect or because the method of use is not safe for lay use except
under the supervision of a licensed veterinarian, adequate directions for lay use cannot
be prepared. However, these veterinary drug products are exempt from Section 502(f)(1) if
all the conditions stated in section 503(f)(2)(A) of the Federal Food, Drug and Cosmetic
Act (Pub. L. 100-670, Sec. 105, 102 Stat. 3971, 1988) and 21 CFR 201.105 are met. Among
other things, the labeling for this class of veterinary drugs must bear the statement
"Caution: Federal law restricts this drug to use by or on the order of a licensed
veterinarian." Furthermore, in order to qualify for the exemption, a veterinary
prescription (Rx) drug must either be (1) in the possession of a person who is regularly
and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail
distribution of veterinary drugs and is to be sold only to or on the prescription or order
of a licensed veterinarian for use in the course of his/her professional practice, or (2)
in the possession of a licensed veterinarian for use in the course of his/her professional
practice.
Serious consequences to the public health and to animal health may result from illegal
sales and use of veterinary Rx drugs. Misuse of veterinary Rx drugs in food-producing
animals may result in unsafe residues in edible products from the treated animals and/or
injury to the treated animals or users. These drugs must be used in accordance with the
directions and supervision of licensed veterinarians within the course of their
professional practice, which involves diagnosis of the disease condition and knowledge of
the animals to be treated, to be exempt from Section 502(f)(1).
REGULATORY ACTION GUIDANCE:
Compliance Program 7371.002 provides guidance on conducting investigations of the
illegal sale of veterinary Rx drugs. The initial step in obtaining correction of the
illegal sales of veterinary Rx drugs is consideration of the issuance of a *warning*
letter. When all of the following criteria are met *warning* letters may be issued
directly by the district for the illegal sales of veterinary Rx drugs:
1. Investigations to document the illegal sales of veterinary Rx drugs have been conducted in accordance with CP 7371.002, Part III, and
2. Investigation has revealed that illegal sales of the veterinary Rx drugs are a sales
practice and not a one-time occurrence. Illegal sale of one or more drugs on more than one
occasion is required, and
3. The drug or drugs are listed in Attachment A of CP 7371.002 and are labeled with the
veterinary Rx legend, "Caution: Federal law restricts this drug to use by or on the
order of a licensed veterinarian," and
4. The drug or drugs are veterinary Rx drug(s) which are approved and listed in 21 CFR
Parts 520-*529* for the specific sponsor(s) identified in the regulation(s), and which
bear the approved sponsor's labeling, and
5. No prescription or other order from a licensed veterinarian for the sale or use of
the veterinary Rx drug(s) by the purchaser is purported to exist, and
6. Interstate origin documentation of the veterinary Rx drug(s) involved is available.
Cases involving illegal sale of veterinary Rx drugs which do not meet all the criteria
for direct issuance of *warning* letters may be submitted to the Center for Veterinary
Medicine, Case Guidance Branch (HFV-236) for review.
SPECIMEN CHARGE:
Section Brief Description
502(f)(1) The drugs are misbranded while held for sale after shipment in interstate commerce within the meaning of Section 502(f)(1) in that the labeling fails to bear adequate directions for use. They are not exempt from such requirements since they are veterinary drugs which, because of toxicity or other potentiality for harmful effect, or the method of their use, are not safe for use except under the supervision of a licensed veterinarian. The drugs fail to comply with the conditions prescribed by 21 U.S.C. 353(f)(2)(A) and 21 CFR 201.105 for exemption from Section 502(f)(1) in that they were sold without a valid prescription or other order of a licensed veterinarian based upon a legitimate veterinarian/ client-patient relationship.
*Material between asterisks is new or revised*
Issued: 2/10/89
Revised: 3/95