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Dispensing Legend Drugs

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Rule 64F-12.006, F.A.C.<br />

(2) The department adopts and incorporates by<br />

reference the labeling requirements for medical<br />

devices as set forth in the federal act at 21 U.S.C.<br />

ss. 301 et seq. and in Title 21 Code of Federal<br />

Regulations Parts 800-895 (as of 10/1/03).<br />

Note: Title 21 Code of Federal Regulations Parts<br />

800-895 contain the specific regulations governing<br />

medical devices. The requirements include<br />

labeling, premarket approval, registration and<br />

listing, medical device reporting, in vitro diagnostic<br />

labeling, investigational devices exemptions, and<br />

device classifications.

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