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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 608.200 Over-The-Counter Sale of Injectable Animal Drugs

 

BACKGROUND:
 

*Section 503(f) 21 CFR 201.105 set forth the conditions for prescription legend requirement on animal drugs.* These include such factors as the toxicity or other potentiality for harmful effect, or the method of use which necessitates the supervision of a licensed veterinarian for safe use. Adequate directions for safe use of such drugs by laypersons cannot be written. Section 503(f)(4) recites the veterinary legend caution statement: "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian." Other terms such as "for veterinary use only," "for sale to graduate veterinarians" are not the prescription legend.*
 

Injectable preparations are in the class of drugs for which adequate directions <> can be written particularly for use in livestock. However, there are *some animal injectable drugs which cannot be safely used except under the supervision of a veterinarian.* These *include the following:*

 

a. All drugs labeled for intravenous (IV) administration in dogs, cats, and other small animals;
 

b. All drugs labeled for intra-articular, intrathecal, epidural, paravertebral, subconjunctival, and retrobulbar administration in all species;
 

c. All drugs labeled for intraperitoneal administration in horses.
 

POLICY:
 

Those animal drugs in a., b., and c. above are in violation of 502(f)(1) unless they bear the prescription legend statement. <>

*REGULATORY ACTION GUIDANCE:

If any of the above dosage forms listed in a., b., or c. are marketed without the veterinary prescription legend they bear inadequate directions for use and are in volation of 502(f)(1). Warning letter recommendations should be submitted to HFV-236 for concurrence.*

*Material between asterisks is new or revised*
<> Indicates material has been deleted

Issued: 10/1/80
Revised: 3/95