D.C. Mun. Regs. r. 16-3615

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

Rule 16-3615 - PHARMACY LICENSURE AND POSTING INFRACTIONS

3615.1

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

(a) D.C. Official Code § 47-2885.03(d) (2005 Repl.)and 22 DCMR B § 1900.1 (operating, maintaining, opening, or establishing a pharmacy within the District of Columbia without a license or registration issued by the Mayor);

(b) D.C. Official Code § 47-2885.03(f) (2005 Repl.)(using or having upon an establishment or institution or any part of an establishment or institution, or displaying within it, or affixing or using in connection with it, a sign bearing the word or words "pharmacy," "apothecary," "drugstore," "druggist," or any word or words of similar or like import which tends to indicate that the practice of pharmacy is being conducted in the establishment or institution);

(c) D.C. Official Code § 47-2885.06 (2005 Repl.), D.C. Official Code § 3-1210.06(b)(4) (2007 Repl.), and 17 DCMR § 6509.3 (unregistered pharmacy intern on duty);

(d) D.C. Official Code § 47-2885.08 (2005 Repl.)(using a pharmacy license for a location other than the one specified on the license; transferring a pharmacy license, using a pharmacy license under a name other than the name under which the license was issued, or failure to promptly surrender a pharmacy license to the Mayor as required);

(e) D.C. Official Code § 47-2885.08(b) (2005 Repl.)(failure to renew a pharmacy license);

(f) D.C. Official Code § 47-2885.09(a) (2005 Repl.) and 22 DCMR B § 1901.1 and § 1901.2 (operating a pharmacy without a pharmacist on duty or with an unlicensed pharmacist on duty);

(g) D.C. Official Code § 47-2885.10(a)(1) (2005 Repl.)(failure to notify the Mayor of a conviction of a felony or violation of a law or regulation of the District of Columbia or the United States relating to drugs by a person named in the application for pharmacy licensure);

(h) D.C. Official Code § 47-2885.10(a)(2) (2005 Repl.) (furnishing false or misleading information to the Mayor or failing to furnish information requested by the Mayor);

(i) D.C. Official Code § 47-2885.17 (2005 Repl.)(peddling drugs);

(j) 22 DCMR B § 1902.1 and 1902.12 (operating a pharmacy outside of the classification for which the license was issued or failing to adhere to the restrictions placed on the license);

(k) 22 DCMR B § 1902.16 (failure to immediately return a pharmacy license to the Director as required);

(l) 22 DCMR B § 1903.3 (shipping, mailing, or delivering in any manner prescription drugs or medical devices into the District of Columbia directly or indirectly without being registered as a non-resident pharmacy by the Department);

(m) 22 DCMR B § 1903.16(e)(1) (failure of a non-resident pharmacy to maintain certification for internet pharmacies acceptable to the Department for each website and domain registration);

(n) 22 DCMR B § 1903.16(e)(2) (failure of a non-resident pharmacy to maintain registration in good standing in the District of Columbia as a foreign corporation); or

(o) 22 DCMR B § 1907.3 (operating a pharmacy in either a temporary or trailer-type facility without a special or limited use license approved by the Director).

3615.2

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

(a) 22 DCMR B § 1902.8 (failure to notify the Director within thirty (30) days after a change in the pharmacist-in-charge, Director of Pharmacy, or Responsible Nuclear Pharmacist);

(b) 22 DCMR B § 1903.8(h) (failure of a non-resident pharmacy to provide all website addresses and domain registrations to the Department);

(c) 22 DCMR B § 1903.10 (failure of a non-resident pharmacy to report a change in the name or address of the resident agent in writing to the Director within thirty (30) days after the change);

(d) 22 DCMR B § 1903.11 (failure of a non-resident pharmacy to report a change in the pharmacist-in-charge or corporate officers within thirty (30) days after the change);

(e) 22 DCMR B § 1903.12 (failure of a non-resident pharmacy to notify the Department within ten (10) days after a change in proprietorship or ownership, pharmacy name, or location or failure to apply for a new registration);

(f) 22 DCMR B § 1903.13 (failure of a non-resident pharmacy to notify the Department within ten (10) days after closing);

(g) 22 DCMR B § 1903.16(a) (failure of a non-resident pharmacy to maintain licensure, registration, or a permit in good standing in the state in which the non-resident pharmacy is located);

(h) 22 DCMR B § 1905.4 (failure to notify the Director at least sixty (60) days prior to the change of proprietorship of a pharmacy or to apply for a new license);

(i) 22 DCMR B § 1906.1 (failure to notify the Director in writing of the closing of a pharmacy not later than fifteen (15) days prior to the anticipated date of closing or failure to include all required information in the notice);

(j) 22 DCMR B § 1906.2 (failure to conspicuously post a sign notifying the public of the closing date of the pharmacy at least fifteen (15) days prior to the closing, failure to include all required information in the notice, or failure to comply with all posting requirements for the location of the notice);

(k) 22 DCMR B § 1906.3 (failure to comply with all District and federal requirements for the transfer of files and records or failure to remove all signs and symbols referencing or indicating the presence of a pharmacy on the premises); or

(l) 22 DCMR B § 1906.4 (failure to submit to the Director all required licenses, registration, and the required written statement within fifteen (15) days after the closing of the pharmacy).

3615.3

Violation of any of the following provisions shall be a Class 3 infraction:

(a) D.C. Official Code § 47-2885.09(a) (2005 Repl.)(failure of pharmacist on duty to post his or her license in a conspicuous place while on duty);

(b) D.C. Official Code § 47-2885.09(a) (2005 Repl.)(failure to conspicuously display on the outside of the pharmacy the hours that the pharmacy is open for business);

(c) D.C. Official Code § 48-801.03 (2009 Repl.)(failure to post the current selling prices for the one hundred (100) most commonly used prescription drugs and related data);

(d) D.C. Official Code § 48-803.03(a) (2009 Repl.)(failure to prominently display a sign regarding drug substitution as required by D.C. Official Code § 48-803.03(a) (2009 Repl.)); or

(e) 22 DCMR B § 1901.3 (failure to post conspicuously in the vicinity of the pharmacy practice area: the pharmacy license, federal and District controlled substances registrations, licenses of pharmacists on duty, certificate of occupancy, and certificates of registration of pharmacy interns).

D.C. Mun. Regs. r. 16-3615

Final Rulemaking published at 52 DCR 5019 (May 27, 2005); as amended by Notice of Final Rulemaking published at 58 DCR 7425 (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.