Dispensing Legend Drugs
Dispensing Legend Drugs
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.