D.C. Mun. Regs. tit. 16, r. 16-3617

Current through Register 71, No. 45, November 7, 2024

Rule 16-3617 - PHARMACY OPERATIONS INFRACTIONS

3617.1

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

(a) D.C. Official Code § 47-2885.09(d) (2005 Repl.)(failure to report a burglary or damage to a pharmacy or its contents by fire, flood, or other cause or dispensing, selling, or giving away a drug or other merchandise damaged by fire, flood, or other cause prior to approval by the Mayor);

(b) D.C. Official Code § 47-2885.10(a)(2) (2005 Repl.), D.C. Official Code § 47-2885.16 (2005 Repl.), and D.C. Official Code § 48-903.02(f) (2009 Repl.)(refusing to allow an inspection in accordance with D.C. Official Code §§ 47-2885.10(a)(2) and 47-2885.16 (2009 Repl.); refusing to allow entry into any pharmacy or drug outlet, at reasonable times, for the purpose of making inspections to determine compliance with this chapter or with other laws or regulations applicable to the practice of pharmacy; or failure to allow the Mayor or an agent of the Mayor entry into an establishment during reasonable hours for the purpose of conducting an inspection of the establishment of a registrant);

(c) D.C. Official Code § 47-2885.11(a)(1) (2005 Repl.; 2011 Supp.)(pharmacy personnel actively engaged in any work, which includes contact with any merchandise or drugs in a pharmacy or the care of dispensing, manufacturing, or storage facilities, in a pharmacy who is affected by a communicable disease, or to be a carrier of a communicable disease in any capacity dispensing, manufacturing, or storing merchandise or drugs when infected with a communicable disease);

(d) D.C. Official Code § 47-2885.11(a)(2) (2005 Repl.; 2011 Supp.)(intentionally permitting a person to engage in work activities while infected with a communicable disease);

(e) D.C. Official Code § 47-2885.11(b)(1) (2005 Repl.; 2011 Supp.)(working in any capacity in a pharmacy when infected with a boil, infectious wound, sore or an acute respiratory infection);

(f) D.C. Official Code § 47-2885.11(b)(3) (2005 Repl.; 2011 Supp.)(working in any capacity in a pharmacy when suffering from chronic alcoholism);

(g) D.C. Official Code § 47-2885.11(b)(2) and (b)(4) (2005 Repl.; 2011 Supp.)(working in any capacity in a pharmacy without following hygienic work practices or while wearing unclean garments);

(h) 22 DCMR B § 1900.4 (failure to maintain written policies and procedures regarding cleanliness and hygiene standards; or ensure employees comply with such);

(i) 22 DCMR B § 1901.8 (failure to report thefts, suspected diversions, significant losses of drug inventory or the inability to account for such inventory, to the Director within forty-eight (48) hours after discovery);

(j) 22 DCMR B § 1903.16(d) (failure of a non-resident pharmacy to comply with all requests for information made by the Department pursuant to 22 DCMR B § 1903);

(k) 22 DCMR B § 1908 (failure to comply with sanitation standards; or performing professional services under unsanitary conditions under District of Columbia or federal laws and regulations);

(l) 22 DCMR B § 1920 (failure to comply with the requirements and duties for a pharmacist-in-charge under District of Columbia or federal laws and regulations);

(m) 22 DCMR B § 1921 (failure to comply with the requirements for institutional pharmacies under District of Columbia or federal laws and regulations); or

(n) 22 DCMR B § 1922 (failure to comply with the requirements for nuclear pharmacies under District of Columbia or federal laws and regulations).

3617.2

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

(a) D.C. Official Code § 47-2885.09(b) (2005 Repl.)(failure of pharmacist on duty to control all professional aspects of the practice of pharmacy, or allowing any usurpation, in reference or impairment of the exercise of professional judgment of the pharmacist on duty by a non-pharmacist proprietor or personnel);

(b) D.C. Official Code § 47-2885.09(c) (2005 Repl.)(failure to securely enclose pharmacy area so as to prevent unauthorized access to pharmacy areas and to prevent the diversion of drugs stored in pharmacy areas; to substantially construct pharmacy and any storage areas for prescription drugs outside of the pharmacy; to have doors capable of being securely locked, to restrict access to pharmacists, the proprietor of the pharmacy, or persons authorized by a pharmacist with the consent of the proprietor; or to maintain the key or keys to the pharmacy areas under the control or in the possession of the pharmacist on duty or the proprietor of the pharmacy);

(c) 22 DCMR B § 1500.1(d) (failure to furnish a sufficient sample of any drug or article of food for analysis);

(d) 22 DCMR B § 1900.3 (having drugs in a pharmacy before a pharmacy license has been obtained from the Director);

(e) 22 DCMR B § 1900.5 (failure to review, revise, or document the review of written policies and procedures as required);

(f) 22 DCMR B § 1907, with the exception of § 1907.3 (failure to comply with the physical standards requirements for operation of a pharmacy under District of Columbia or federal laws or regulations); or

(g) 22 DCMR B § 1910, with the exception of § 1910.9 (failure to comply with security and safeguards against diversion requirements under District of Columbia or federal laws and regulations).

3617.3

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

(a) D.C. Official Code § 48-801.04 (2009 Repl.)(failure to make available upon request the current selling price of all prescription drugs, including those not required to be posted, dispensed by each pharmacy and the pharmacy's discounts and professional and convenience services and charges therefor);

(b) D.C. Official Code § 48-801.05 (2009 Repl.)(failure to provide to any consumer the discounts and services stated on the poster, under the eligibility, price, and other terms there stated);

(c) 22 DCMR B § 1909 (failure to comply with the equipment and reference material requirements under District of Columbia or federal laws and regulations); or

(d) 22 DCMR B § 1910.9 (displaying or storing drugs, medical devices, or medical supplies in an area accessible to the public which are (1) prescription drugs or devices; (2) devices that may be used in the administration of controlled substances; (3) over-the counter medicines that contain controlled substances; or (4) over-the-counter medicines that have been identified by the Food and Drug Administration or the Director as having a potential for misuse or abuse).

D.C. Mun. Regs. tit. 16, r. 16-3617

Final Rulemaking published at 52 DCR 5026 (May 27, 2005); as amended by Notice of Final Rulemaking published at 58 DCR 7425, 7432 (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.