D.C. Mun. Regs. tit. 22, r. 22-B1500

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

Rule 22-B1500 - AUTHORITY TO MAKE INSPECTIONS

1500.1

In carrying out its functions under the Act, the Chief Pharmaceutical Control Officer and his or her designee, is authorized in accordance with §§ 302(f) and 505 of the Act to enter controlled premises and conduct administrative and non-administrative inspections thereof, for the purpose of doing the following:

(a) Inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept or made under the Act and this chapter including, but not limited to, inventory and other records required to be kept pursuant to this chapter, prescription and distribution records required to be kept pursuant to this chapter, shipping records identifying the name of each carrier used and the date and quantity of each shipment, and storage records identifying the name of each warehouse used and the date and quantity of each storage;

(b) Inspecting within reasonable limits and in a reasonable manner all pertinent equipment, finished and unfinished controlled substances and other substances or materials, containers, and labeling found at the controlled premises relating to the Act;

(c) Making a physical inventory of all controlled substances on hand at the premises;

(d) Collecting samples of controlled substances or precursors (in the event any samples are collected during an inspection, the inspector shall issue a receipt for such samples to the owner, operator, or agent in charge of the premises);

(e) Checking records and information on distribution of controlled substances by the registrant as they relate to total distribution of the registrant (i.e., has the distribution in controlled substances increased markedly within the past year, and if so why); and

(f) Except as provided by the Act, all other things therein (including records, files, papers, processes, controls and facilities) appropriate for verification of the records, reports, documents referred to in this section or otherwise bearing on the provisions of the Act cited in this section and this chapter.

1500.2

If an administrative inspection warrant is required for inspection pursuant to § 505 of the Act (D.C. Code, 2001 Ed. § 48-905.05) , the Chief shall be responsible for seeking the warrant.

1500.3

The Chief may, without a warrant, inspect books and records pursuant to an administrative subpoena issued in accordance with § 507 of the Act (D.C. Code, 2001 Ed. § 48-905.07) and in situations described in § 505(a)(4) of the Act D.C. Code, 2001 Ed. § 48-905.05(a)(4).

1500.4

An inspection authorized by this section shall not extend to financial data, sales data, other than shipment data, or pricing data unless the owner, operator, or agent in charge of the controlled premises consents in writing.

1500.5

Refusal by the registrant or owner, operator, agent or other person in charge of the controlled premises to allow an inspection shall constitute a basis for suspension or revocation of registration in the following circumstances:

(a) When inspection is authorized pursuant to an administrative inspection warrant issued pursuant to § 505(b) of the Act (D.C. Code, 2001 Ed. § 48-905.05(b)); and

(b) When inspection is authorized pursuant to this chapter and § 505(a)(4)(B), (C), (D) or (E) of the Act (D.C. Code, 2001 Ed. § 48-905.05(a)(4) (B), (C), (D) or (E)) .

D.C. Mun. Regs. tit. 22, r. 22-B1500

Final Rulemaking published at 33 DCR 1046, 1077 (February 21, 1986)

AUTHORITY: Unless otherwise noted, the authority for this chapter is Title III of the District of Columbia Uniform Controlled Substances Act of 1981, D.C. Code, 2001 Ed. §§ 48-903.01 to 48-903.09; Mayor's Order 85-171 (October 18, 1985).