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

[[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