Section 22-B6911. MANUFACTURE FOR MEDICAL DIAGNOSTIC USES

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6911.1A specific license authorizing the distribution of radioactive material for use by physicians under the general license in §6806 of chapter 68 of this title shall be issued only if the requirements of this section are met.

6911.2The applicant for the license shall submit evidence that the radioactive material is to be manufactured, labeled, and packaged in accordance with the following:

(a)A new drug application which the Commissioner of Food and Drugs, of the Food and Drug Administration, has approved; or

(b)A license for a biologic product issued by the Secretary of Health and Human Services.

6911.3A label or statement containing information as the Director may require shall be affixed to the container or shall appear in the leaflet or brochure that accompanies the package of radioactive material.

source

Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1021(j); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

                    
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