D.C. Mun. Regs. tit. 22, r. 22-B1925

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B1925 - INSPECTION AND INVESTIGATION

1925.1

The Director, or his agent, shall have the right to enter upon and into the premises of any licensee, registrant, applicant for a license or registration, pharmacy or other location where prescription drugs or devices are stored, or reasonably believed to be stored:

(a) At reasonable times,

(b) After presenting proper identification; and

(c) For the purpose of making compliance inspections or conducting complaint investigations concerning the laws and regulations applicable to the practice of pharmacy, operation of pharmacies, and handling of controlled and prescription drugs.

1925.2

An inspection or investigation conducted under this Title may include:

(a) The examination of the pharmacy records, including prescriptions, invoices, and inventory records;

(b) The obtaining of prescriptions, information, and samples pertaining to drugs dispensed;

(c) The examination of any drugs, medical devices, or any other pharmaceutical products or medicinal chemicals that are in the pharmacy; and

(d) The review of any records and publications that are required by any applicable District of Columbia or federal laws or regulations to be kept in a pharmacy.

1925.3

The Director may delegate to staff of the Department the authority to conduct inspections of pharmacy operations covered by this chapter. Inspections shall be conducted upon the issuance of a new license and at least annually thereafter. Inspections may be conducted more frequently as often as the Director deems necessary or useful.

1925.4

The Director shall delegate staff to investigate complaints of violations of the Act, this chapter, and all other applicable laws and regulations regarding the practice of pharmacy and the operation of a pharmacy.

1925.5

The Director may delegate to staff of the Department the authority to conduct compliance inspections, audits, and other inspections required under the Act to ensure accountability for all controlled substances and to ensure compliance with laws regulating the practice of pharmacy and the distribution of prescription drugs and devices in the District and all other applicable laws and regulations regarding the practice of pharmacy and the operation of a pharmacy.

D.C. Mun. Regs. tit. 22, r. 22-B1925

Final Rulemaking published at 38 DCR 6734, 6766 (November 8, 1991); as amended by Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Final Rulemaking published at 57 DCR 5741 (July 2, 2010)

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) ); section 301 of the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981, (D. C. Law 4-29; D.C. Official Code § 48-903.01); Mayor's Order 98-48, dated April 15, 1998 98-48 delegates the Mayor's authority under Pharmacist Act); 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); 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)); and Mayor's Order 98-88, dated May 29, 1998