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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 22. HEALTH |
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SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
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Chapter 22-B19. PHARMACIES |
Section 22-B1907. PHYSICAL STANDARDS
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1907.1The physical standards contained in this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director.
1907.2A pharmacy shall meet the applicable requirements of the District of Columbia zoning, building, fire, plumbing, and electrical codes.
1907.3A pharmacy shall not be permitted to operate in either a temporary or trailer-type facility, except by special or limited use license as approved by the Director.
1907.4The prescription drug compounding and dispensing area shall:
(a)Be a minimum of one hundred fifty (150) square feet in area, except that a pharmacy licensed prior to the effective date of these rules may be of a lesser square footage as approved by the Director;
(b)Have a minimum of ten (10) square feet of counter space for the pharmacist-in-charge, with additional space for each additional pharmacist on duty, to compound and dispense drugs safely and efficiently, except that a pharmacy licensed prior to the effective date of this chapter may be of lesser square footage of counter space as approved by the Director;
(c)Shall contain an area which is suitable for confidential patient counseling, if the pharmacy serves the public;
(d)Be separated from other areas by a barrier which renders the area inaccessible to unauthorized persons;
(e)Provide an unobstructed view of the pharmacist on duty;
(f)Be properly lighted and ventilated;
(g)Have a sink and goose-neck faucet with hot and cold running water within the dispensing and compounding area, for the immediate access and use of all pharmacy personnel, maintained in a sanitary condition and shall include:
(1)Soap or detergent; and
(2)Air-driers or single-use towels.
(h)Maintain the temperature of the pharmacy within a range compatible with the proper storage of drugs; and
(i)Have refrigeration facilities exclusively for the storage of drugs requiring cold storage with a thermometer controlling the interior temperature to keep it maintained between thirty-six degrees Fahrenheit (36°F) and forty-six degrees Fahrenheit (46°F).
1907.5All areas where drugs and medical devices are stored, shall be dry, well lighted, well ventilated, maintained at a temperature safe for the storage of drugs as specified by the United States Pharmacopoeia/National Formulary (USP/NF) or the United States Food and Drug Administration (USFDA) and maintained in a clean and orderly condition.
1907.6Storage areas shall be maintained at temperatures which will ensure the integrity of the drugs prior to their dispensing as stipulated by the United States Pharmacopoeia/National Formulary (USP/NF) and/or the manufacturer's or distributor's labeling unless otherwise indicated by the Bureau of Food, Drug & Radiation Protection, Pharmaceutical Control Division.