D.C. Mun. Regs. tit. 22, r. 22-B10310
Current through Register Vol. 71, No. 49, December 6, 2024
Rule 22-B10310 - PRESCRIPTION DEVICES10310.1A device which, because of any potential for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from 21 U.S.C. § 352(f)(1) if all the following conditions are met:
(a) The device is: (1) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or(2) In the possession of a practitioner, such as a physician, dentist, or veterinarian, licensed by law to use or order the use of such device; and(3) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his or her professional practice.(b) The label of the device, other than surgical instruments, bears: (1) The statement "Caution: Federal law restricts this device to sale by or on the order of a ----------", the blank to be filled with the word "physician," "dentist," or "veterinarian," or with the descriptive designation of any other practitioner licensed by the law of the state in which he practices to use or order the use of the device; and(2) The method of its application or use;(c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented; provided, however, that such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Upon written request, stating reasonable grounds therefore, the Department will offer an opinion on a proposal to omit such information from the dispensing package under this provision;(d) Any labeling, as defined in 21 U.S.C. § 321(m) of the act, whether or not it is on or within a package from which the device is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented; and(e) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.D.C. Mun. Regs. tit. 22, r. 22-B10310
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.