10311. RETAIL EXEMPTION FOR PRESCRIPTION DEVICES

10311 RETAIL EXEMPTION FOR PRESCRIPTION DEVICES 10311.1 A device subject to § 10310.1 shall be exempt at the time of delivery to the ultimate purchaser or user from 21 U.S.C. § 352(f)(1) if it is delivered by a licensed practitioner in the course of his or her professional practice or upon a prescription or other order lawfully issued in the course of his or her professional practice, with labeling bearing the name and address of such licensed practitioner and the directions for use and cautionary statements, if any, contained in such order. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10311