[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
