D.C. Mun. Regs. tit. 22, r. 22-B1907

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

Rule 22-B1907 - PHYSICAL STANDARDS

1907.1

The physical standards contained in this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director.

1907.2

A pharmacy shall meet the applicable requirements of the District of Columbia zoning, building, fire, plumbing, and electrical codes.

1907.3

A 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.

1907.4

The 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) Satisfy compounding space requirements as follows:

(1) For the compounding of non-sterile and sterile pharmaceuticals, 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;

(2) Beginning six (6) months after the effective date of these regulations, for the compounding of non-sterile pharmaceuticals, satisfy all other compounding space requirements established in the current published edition of USP General Chapter 795, 800; and

(3) Beginning six (6) months after the effective date of these regulations, for the compounding of sterile pharmaceuticals, satisfy all compounding space requirements as established in the current published edition of USP General Chapter 797, 800;

(c) 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 within the dispensing and compounding area for the immediate access and use of all pharmacy personnel, maintained in a sanitary condition, which shall provide hot running water no less than one hundred and ten degrees Fahrenheit (110° F) (forty-three and one-third degrees Celsius (43.3° C)), cold running water, and shall include:

(1) Soap or detergent from a dispenser; and

(2) Air-driers or single-use non shedding towels;

(h) Maintain the temperature of the pharmacy within a range compatible with the proper storage of drugs;

(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); and

(j) Beginning six (6) months after the effective date of these regulations, comply with all other requirements of the current published editions of USP General Chapters 795, 797, and 800 relevant to the type of compounding being undertaken.

1907.5

All 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.

1907.6

Storage 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.

D.C. Mun. Regs. tit. 22, r. 22-B1907

Final Rulemaking published at 38 DCR 6734, 6739 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); amended by Final Rulemaking published at 64 DCR 8588 (9/1/2017); amended by Final Rulemaking published at 69 DCR 2763 (4/1/2022)