Statutes, codes, and regulations
District Of Columbia Administrative Code
Title 22 - HEALTHSubtitle 22-B - PUBLIC HEALTH AND MEDICINE
Chapter 22-B107 - QUALITY SYSTEM REGULATION
Rule 22-B10717 - DEVICE LABELING

D.C. Mun. Regs. tit. 22, r. 22-B10717

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Current through Register Vol. 71, No. 49, December 6, 2024
Rule 22-B10717 - DEVICE LABELING
10717.1

Each manufacturer shall establish and maintain procedures to control labeling activities.

10717.2

Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate, use.

10717.3

Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct expiration date, control number, storage instructions, handling instructions, and any additional processing instructions. The release, including the date and signature of the individual(s) performing the examination, shall be documented in the DHR.

10717.4

Each manufacturer shall store labeling in a manner that provides proper identification and is designed to prevent mix-ups.

10717.5

Each manufacturer shall control labeling and packaging operations to prevent labeling mix-ups. The label and labeling used for each production unit, lot, or batch shall be documented in the DHR.

10717.6

Where a control number is required by § 10709, that control number shall be on or shall accompany the device through distribution.

D.C. Mun. Regs. tit. 22, r. 22-B10717

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.