D.C. Mun. Regs. r. 16-3616

Current through Register Vol. 71, No. 25, June 21, 2024

Rule 16-3616 - CONTROLLED SUBSTANCES INFRACTIONS

3616.1

Violation of any of the following provisions shall be a Class 1 infraction:

(a) D.C. Official Code § 48-903.02(a) (2009 Repl.)(failure to register or maintain a current District of Columbia controlled substances registration before manufacturing, distributing, or dispensing a controlled substance within the District of Columbia);

(b) D.C. Official Code § 48-903.02(b) (2009 Repl.)(possessing, manufacturing, distributing, dispensing, or conducting research with controlled substances beyond the extent authorized by a registration);

(c) D.C. Official Code § 48-903.03(c) (2009 Repl.)(failure of a practitioner to be registered prior to dispensing a controlled substance or conducting research with a controlled substance in Schedules II through V);

(d) D.C. Official Code § 48-903.02(e) (2009 Repl.)(failure to obtain a separate registration for each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances);

(e) D.C. Official Code § 48-903.06 (2009 Repl.) and 22 DCMR B § 1502.1 (failure of a registrant to keep records and maintain inventories in conformance with the record-keeping and inventory requirements of federal law, laws of the District of Columbia, and with any additional rules which the Mayor issues);

(f) D.C. Official Code § 48-903.07 (2009 Repl.) and 22 DCMR B § 1504.1 (failure of a registrant to distribute a controlled substance in Schedule I or II to another registrant only pursuant to the required order form);

(g) D.C. Official Code § 48-903.08(a) (2009 Repl.) and 22 DCMR B §§ 1913.1, et seq., with the exception of § 1913.6 (failure to maintain controlled substance prescription records in conformity with the requirements of 22 DCMR B §§ 1913.1, et seq.);

(h) D.C. Official Code § 48-903.08(a) (2009 Repl.) and 22 DCMR B §§ 1306.1, et seq. (dispensing a controlled substance in Schedule II without the written prescription of a practitioner, except as provided for emergency situations in 22 DCMR B § 1306.5 );

(i) D.C. Official Code § 48-903.08(b) (2009 Repl.)(refilling a controlled substance in Schedule II);

(j) 22 DCMR B § 1309 (dispensing a controlled substance in Schedule III, IV, or V without the written, oral prescription, or telephone facsimile prescription of a practitioner);

(k) 22 DCMR B § 1310 (refilling a controlled substance in Schedule III, IV, or V more than six (6) months after the date on which the prescription was issued or more than five (5) times);

(l) 22 DCMR B § 1303.3 (dispensing a prescription, or performing any part of the dispensing process, pursuant to a telephone facsimile prescription that was not transmitted by a practitioner or a practitioner's designated agent directly from the practitioner's office or a health care facility to the pharmacy with no intervening person having access to the prescription drug order);

(m) 22 DCMR B § 1305.2 (issuing or dispensing a prescription for a controlled substance that is not for a legitimate medical purpose or that was not prescribed by an individual practitioner acting in the usual course of his or her professional practice);

(n) 22 DCMR B § 1305.3 (issuing a prescription for a controlled substance to an individual practitioner for general dispensing purposes);

(o) 22 DCMR B § 1305.4 (issuing a controlled substance in any schedule for the purpose of continuing a patient's dependency to a person or entity other than an authorized narcotic treatment rehabilitation program);

(p) 22 DCMR B § 1306.5 (failure to obtain original prescriptions within seven (7) days for emergency oral orders or dispensing more than a seven (7)-day supply of an emergency order);

(q) 22 DCMR B § 1306.2 (filling a controlled substance in Schedule II more than thirty (30) days after the prescription was written, except as permitted in 22-B DCMR § 1306.2 );

(r) 22 DCMR B § 1306.3 and 22 DCMR B § 1503.1 (failure to cancel out a controlled substance in Schedule II by drawing a line through it with the date dispensed and initials of the person who dispensed it);

(s) 22 DCMR B § 1306.4 (failure to obtain the original written prescription before dispensing a controlled substance in Schedule II prescription that was transmitted via telephone facsimile);

(t) 22 DCMR B § 1310.6 (failure to properly document an oral refill authorization of a schedule III, IV, or V prescription or refilling a schedule III, IV, or V prescription for a quantity greater than the amount authorized for the initial filling of the prescription);

(u) 22 DCMR B § 1306.7 to § 1306.9 (failure to comply with requirements for dispensing a controlled substance in Schedule II that is transmitted via telephone facsimile when the facsimile will serve as the original prescription);

(v) 22 DCMR B § 1311.1 (a partial filling of a Schedule III, IV, or V prescription that exceeds the total quantity prescribed);

(w) 22 DCMR B § 1317 (failure to comply with the provisions for administering or dispensing controlled substances for purposes of detoxification or in the course of an authorized clinical investigation in the development of a narcotic addict rehabilitation program);

(x) 22 DCMR B § 1320.1 (distribution of a controlled substance by a practitioner who is authorized to dispense a controlled substance to an unauthorized person or entity);

(y) 22 DCMR B § 1320.2 (failure of a practitioner who is authorized to dispense a controlled substance to obtain a registration to distribute controlled substances when the practitioner has reason to believe that the total number of dosage units of controlled substances which will be distributed by him or her to another practitioner will exceed five percent (5%) of the total number of dosage units distributed and dispensed by him or her during the twelve (12) month period);

(z) 22 DCMR B § 1321 (failure to comply with the provisions for distribution of controlled substances to a supplier);

(aa) 22 DCMR B § 1322 (failure to comply with the provisions for distribution of controlled substances upon discontinuance or transfer of business activities);

(bb) 22 DCMR B § 1323.1 (failure to comply with the provisions or manufacture and distribution of controlled substance solutions and compounds by a pharmacist);

(cc) 22 DCMR B § 1324.1 (failure of a registrant to properly dispose of controlled substances); or

(dd) 22 DCMR B § 1502.1 and 22 DCMR B § 1000.2 (failure to register or maintain a current federal controlled substances registration before manufacturing, distributing, or dispensing a controlled substance within the District of Columbia).

3616.2

Violation of any of the following provisions shall be a Class 2 infraction:

(a) D.C. Official Code § 48-903.08(e) (2009 Repl.) and 22 DCMR B § 1912 (failure to affix to a container in which a controlled substance is dispensed a label meeting the requirements set forth in 22 DCMR B § 1912 and 22 DCMR B § 1308 and 22 DCMR B § 1312 );

(b) 22 DCMR B § 1311.1 (failure to properly document the partial filling of a prescription for a controlled substance);

(c) 22 DCMR B § 1311.2 (failure to notify the prescriber when the remaining portion of a partially filled Schedule III, IV, or V prescription cannot be supplied within seventy-two (72) hours);

(d) 22 DCMR B § 1311.2 (filling a partial Schedule III, IV, or V prescription beyond the seventy-two (72) hour limit without a new prescription); or

(e) 22 DCMR B §§ 1314.1, et seq. (failure to comply with the provisions for dispensing a controlled substance listed in Schedule II, III, IV, or V, which is not a prescription drug, without a prescription to a purchaser at retail).

D.C. Mun. Regs. r. 16-3616

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)

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,