[Federal Register Volume 59, Number 172 (Wednesday, September 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22035]


[[Page Unknown]]

[Federal Register: September 7, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94D-0242]

 

Nonparenteral Animal Drugs Packaged for Parenteral Use; 
Compliance Policy Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a new Compliance Policy Guide (CPG) 7125.39 entitled 
``Drugs Packaged for Infusion or Injection of Food-Producing Animals.'' 
This CPG provides policy and regulatory action guidance to the Food and 
Drug Administration (FDA) field and headquarters staff regarding the 
status of products labeled for nonparenteral use in animals with 
packaging appropriate for parenteral use in food-producing animals.

ADDRESSES: Submit written requests for single copies of CPG 7125.39 
entitled ``Drugs Packaged for Infusion or Injection of Food-Producing 
Animals'' to the Industry Information Staff (HFV-12), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855. Requests should be identified with the CPG number 
and title, as well as the docket number found in brackets in the 
heading of this document. Send two self-addressed adhesive labels to 
assist that office in processing your requests. CPG 7125.39 is 
available for public examination in the Dockets Management Branch (HFA-
305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Judith A. Gushee, Center for 
Veterinary Medicine (HFV-236), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1785.

SUPPLEMENTARY INFORMATION: FDA had determined that a number of products 
are packaged in parenteral-like packaging although labeled for topical, 
oral, or other route of administration. The policy states that oral and 
topical preparations for food-producing animals should not be packaged 
to facilitate parenteral administration. FDA is concerned about safety 
of these unapproved products when infused or injected into food-
producing animals. Serious animal and human health consequences can 
result from this practice. Products packaged as if for parenteral 
administration that do not bear adequate directions for parenteral 
administration will be deemed misbranded.
    The statements made in CPG 7125.39 are not intended to bind the 
courts, the public, or FDA, or to create or confer any rights, 
privileges, immunities, or benefits on or for any private person, but 
are intended merely for internal FDA guidance.

    Dated: August 31, 1994.
Ronald G. Chesemore,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 94-22035 Filed 9-6-94; 8:45 am]
BILLING CODE 4160-01-F