[Code of Federal Regulations] [Title 21, Volume 7] [Revised as of April 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR610.2] [Page 63] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents Subpart A--Release Requirements Sec. 610.2 Requests for samples and protocols; official release. (a) General. Samples of any lot of any licensed product, except for radioactive biological products, together with the protocols showing results of applicable tests, may at any time be required to be sent to the Director, Center for Biologics Evaluation and Research. Upon notification by the Director, Center for Biologics Evaluation and Research, a manufacturer shall not distribute a lot of a product until the lot is released by the Director, Center for Biologics Evaluation and Research: Provided, That the Director, Center for Biologics Evaluation and Research, shall not issue such notification except when deemed necessary for the safety, purity, or potency of the product. (b) Radioactive biological products. Samples of any lot of a radioactive biological product, as defined in Sec. 600.3(ee) of this chapter, together with the protocols showing results of applicable tests, may at any time be required to be sent to the Food and Drug Administration for official release. Upon notification by the Director, Center for Drug Evaluation and Research, a manufacturer shall not distribute a lot of a radioactive biological product until the lot is released by the Director, Center for Drug Evaluation and Research: Provided, That the Director, Center for Drug Evaluation and Research shall not issue such notification except when deemed necessary for the safety, purity, or potency of the product. [40 FR 31313, July 25, 1975, as amended by 49 FR 23834, June 8, 1984; 50 FR 10941, Mar. 19, 1985; 55 FR 11013 and 11014, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002] [[Page 64]]