D.C. Mun. Regs. tit. 22, r. 22-B10311
Current through Register Vol. 71, No. 49, December 6, 2024
Rule 22-B10311 - RETAIL EXEMPTION FOR PRESCRIPTION DEVICES10311.1A 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.
D.C. Mun. Regs. tit. 22, r. 22-B10311
Final Rulemaking published at 60 DCR 10252 (July 12, 2013)Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.