[Federal Register Volume 60, Number 142 (Tuesday, July 25, 1995)]
[Rules and Regulations]
[Pages 37935-37936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18227]



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[[Page 37936]]


DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

9 CFR Part 112

[Docket No. 92-098-4]


Viruses, Serums, Toxins, and Analogous Products; Packaging and 
Labeling

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule; confirmation of effective date.

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SUMMARY: This document confirms that the final rule on the packaging 
and labeling of veterinary biological products becomes effective on 
August 19, 1995. Upon the effective date, the final rule prohibits the 
repackaging and relabeling, for further sale or distribution, of final 
containers of product that are imported or that are prepared at 
licensed establishments.
    After the effective date, veterinary biological products that have 
been repackaged before that date may continue to be distributed for 
further sale for a period of 6 months until February 19, 1996, to 
permit final distribution of repackaged biologics that remain in 
marketing channels. During the course of the six-month period, APHIS 
will be closely monitoring the availability of single-dose or 
individually-packaged products for use by non-veterinarians.

EFFECTIVE DATE: The effective date of the final rule published at 59 FR 
43441 (August 24, 1994) and postponed at 60 FR 2876 (January 12, 1995) 
is confirmed as August 19, 1995.

FOR FURTHER INFORMATION CONTACT: Dr. David A. Espeseth, Deputy 
Director, Veterinary Biologics, BBEP, APHIS, 4700 River Road Unit 148, 
Riverdale, MD, 20737-1237, (301) 734-8245.

SUPPLEMENTARY INFORMATION: Under authority of the Virus-Serum-Toxin Act 
(21 U.S.C. 151-159), as amended by the Food Security Act of 1985, the 
Animal and Plant Health Inspection Service (APHIS), U.S. Department of 
Agriculture, published a proposed rule on April 28, 1993 (58 FR 25786-
25788, Docket No. 92-098-1) concerning repackaging and relabeling of 
veterinary biologics. During the 60-day comment period, thirty-nine 
comments were received. Thirty-six comments were in support of the 
rule; three were not. The final rule was published on August 24, 1994 
(59 FR 43441-43445, Docket No. 92-098-2) with a 180-day transition 
period before the rule was scheduled to become effective on February 
21, 1995. The purpose of the rule is to ensure that products are not 
repackaged or relabeled after leaving a licensed establishment.
    To allow additional time for arrangements to be made for the 
production of single-dose or individually-packaged biological products 
that would be in compliance with the provisions of the final rule, 
APHIS postponed the effective date of the rule an additional 180 days 
until August 19, 1995 (60 FR 2876-2877, Docket No. 92-098-3, January 
12, 1995). Several manufacturers are currently producing such products 
for distributors for further sale to consumers.
    This document provides notice to interested persons that the final 
rule on the repackaging and relabeling of veterinary biologics will 
take effect on August 19, 1995, as announced in the January 12, 1995, 
Federal Register notice.
    After the August 19, 1995, effective date of the rule, veterinary 
biological products that have already been repackaged before that date 
may continue to be distributed for further sale for a period of 6 
months until February 19, 1996, to permit final distribution of 
repackaged biologics in marketing channels. Distribution of products 
repackaged after August 19, 1995, would not be allowed.
    During the course of the six-month transition period, APHIS will be 
closely monitoring the availability of single-dose products for use by 
non-veterinarians. APHIS is committed to ensuring the availability of 
single-dose products and will take whatever action may be necessary to 
assure that sufficient product is available for use by consumers.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).

    Done in Washington, DC, this 19th day of July, 1995.
Terry Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-18227 Filed 7-21-95; 8:45 am]
BILLING CODE 3410-34-P