C.F.R. » Title 9 » CHAPTER I—ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE › SUBCHAPTER E—VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS › PART 102—LICENSES FOR BIOLOGICAL PRODUCTS

9 C.F.R. § 102.6

Conditional licenses

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In order to meet an emergency condition, limited market, local situation, or other special circumstance, including production solely for intrastate use under a State-operated program, the Administrator may, in response to an application submitted as specified in § 102.3(b) of this part, issue a conditional U.S. Veterinary Biological Product License to an establishment under an expedited procedure which assures purity and safety, and a reasonable expectation of efficacy. Preparation of products under a conditional license shall be in compliance with all applicable regulations and standards and may be restricted as follows:

(a) The preparation may be limited to a predetermined time period which shall be established at the time of issuance and specified on the license. Prior to termination of the license, the licensee may request reissuance. Such requests shall be substantiated with data and information obtained since the license was issued. After considering all data and information available, the Administrator shall either reissue the U.S. Veterinary Biological Product License or allow it to terminate.

(b) Distribution may be limited to the extent necessary to assure that the product will meet the basic criteria for issuance of the conditional license.

(c) Labeling for the product may be required to contain information on the conditional status of the license.

[52 FR 11026, Apr. 7, 1987, as amended at 60 FR 48021; Sept. 18, 1995]
Notes of Decisions
Cited in 1 case, 2002–2002 · leading case: Behrens v. United Vaccines, Inc., 189 F. Supp. 2d 945 (D. Minnesota 2002).
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Behrens v. United Vaccines, Inc., 189 F. Supp. 2d 945 (D. Minnesota 2002). “” 9 C.F.R. § 102.6 . 6 . We do note, as the Court did in Garretts v.”
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