D.C. Mun. Regs. tit. 16, § 3616
Controlled Substances Infractions
Authority: The Director of the Department of Health (Department), pursuant to the authority set forth in section 104 of the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985, effective October 5, 1985 (D.C. Law 6-42, D.C. Official Code § 2-1801.04 (2007 Repl.; 2011 Supp.)); Mayor's Order 99-68, dated April 28, 1999; Reorganization Plan No. 4 of 1996; 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.; 2011 Supp.)); 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.)); the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (D. C. Law 4-29; D.C. Official Code §§ 48-901.01, et seq. (2009 Repl.; 2011 Supp.)); Mayor’s Order 98-48, dated April 15, 1998, Section 15 of the District of Columbia Drug Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2009 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998, Source: Final Rulemaking published at 52 DCR 5024 (May 27, 2005); as amended by Notice of Final Rulemaking published at 58 DCR 7425, 7428 (August 19, 2011).District of Columbia, Office of the Secretary
3616.1 Violation of any of the following provisions shall be a Class 1 infraction:
- (a) D.C. Official Code § 47-2885.15(a) and § 47-2885.15(c) (failure to maintain in every pharmacy, or in the establishment or institution where a pharmacy is located, a suitable book, file, or other easily retrievable record, for a period of not less than two (2) years for every prescription compounded dispensed at the pharmacy for inspection, during regular business hours);
- (b) D.C. Official Code § 47-2885.15(b)(1) and § 47-2885.15(c) (failure to maintain in every pharmacy, or in the establishment or institution where a pharmacy is located, bound volumes recording the information required by law or regulation concerning the over-the-counter sales of those drugs which are listed in Schedule V established or amended pursuant to the federal Comprehensive Drug Abuse Prevention and Control act of 1970 (21 U.S.C. § 801 et seq. for inspection, during regular business hours);
- (c) D.C. Official Code § 47-2885.15(b)(2)(A) and § 47-2885.15(c) (failure to maintain in every pharmacy, or in the establishment or institution where a pharmacy is located, bound volumes recording the information required by law or regulation concerning hypodermic syringes, needles, or other medical devices for inspection, during regular business hours);
- (d) D.C. Official Code § 47-2885.15(b)(2)(B) and § 47-2885.15(c) (failure to maintain in every pharmacy, or in the establishment or institution where a pharmacy is located, bound volumes recording the information required by law or regulation concerning gelatin capsules for inspection, during regular business hours);
- (e) D.C. Official Code § 47-2885.15(b)(2)(C) and § 47-2885.15(c) (failure to maintain in every pharmacy, or in the establishment or institution where a pharmacy is located, bound volumes recording the information required by law or regulation concerning diluents of adulterants for inspection, during regular business hours);
- (f) 22 DCMR § 1007.1 (using a controlled substances registration for a location other than the one specified on the registration);
- (g) 22 DCMR § 1502.1 (failure of registrant to keep records, maintain inventories and file reports in conformance with the requirements of federal law, including the requirements prescribed under 21 CFR, Part 1304);
- (h) 22 DCMR § 1503.1 (failure of pharmacies to maintain invoices, prescription files, and other records required by federal and District of Columbia laws and regulations);
- (i) 22 DCMR § 1503.2 (failure of medical, dental, and veterinary practitioners to maintain invoices, prescription files, and other records required by federal and District of Columbia laws and regulations);
- (j) 22 DCMR § 1503.3 (failure of manufacturers and distributors (including wholesalers) to maintain invoices received and distributed and other records required by federal and District of Columbia laws and regulations);
- (k) 22 DCMR § 1505.1 (failure to retain all records required by 22 DCMR, Chapter 15 for a period of at least two (2) years);
(l) 22 DCMR § 1913.1 (failure of registrant (pharmacy, hospital, clinic, ambulatory surgery center or any other medical treatment facility or establishment) to dispense a controlled substance on an outpatient basis without a label affixed to the container with the information as specified in subsections 1913.1(a) through (g); or
(m) 22 DCMR § 1920.1 (failure of registrant to immediately report to the Department a burglary, robbery, thief, loss, or damage involving due to fire, flood, or other causes).
3616.2 Violation of any of the following provisions of 22 DCMR Chapters 13 and 15 (Schedule I or II -- DEA Order Forms) shall be a Class 1 infraction:
(a) 22 DCMR § 1305.7 (failure to obtain original prescriptions within 72 hours for emergency oral orders); or
(b) 22 DCMR § 1504.1 (failure of registrant to distribute controlled substances in Schedule I and II to another registrant only pursuant to an order form).
3616.3 Violation of any of the following provisions of 22 DCMR Chapter 13 (Schedules III, IV, and V -- DEA Order Forms) shall be a Class 1 infraction:
(a) 22 DCMR § 1310.1 (filling or refilling a prescription for controlled substance listed in Schedule III, IV, or V more than 6 months after the date on which prescription was issued);
(b) 22 DCMR § 1310.2 (refilling a prescription for controlled substance more than 5 times);
(c) 22 DCMR § 1314.1(b) (dispensing a controlled substance listed in Schedule II, III, IV, or V without a prescription to a purchaser at retail in a quantity greater than 240cc (8 oz.) or 48 dosage unit of any controlled substance containing opium to same purchaser in 48 hour period without prescription); or
(d) 22 DCMR § 1314.1(b) (dispensing a controlled substance listed in Schedule II, III, IV, or V without a prescription to a purchaser at retail in a quantity greater than 120cc (4 oz.) or 24 dosage unit of any controlled substance to same purchaser in 48 hour period without prescription).
SOURCE: Final Rulemaking published at 52 DCR 5024 (May 27, 2005).