D.C. Mun. Regs. tit. 22, r. 22-B10316

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10316 - MEDICAL DEVICES: EXPIRATION OF EXEMPTIONS

10316.1

If a shipment or delivery, or any part thereof, of a device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt, or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such device being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device.

10316.2

The exemptions conferred by §§ 10313 through 10315 of this chapter shall continue until the devices are used for the purposes for which they are exempted, or until they are relabeled to comply with 21 U.S.C. § 352(f)(1). If, however, the device is converted, or manufactured into a form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the device is labeled as required by § 10310 of this chapter.

D.C. Mun. Regs. tit. 22, r. 22-B10316

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.