Nev. Admin. Code § 585.300

Current through November 8, 2024

Section 585.300 - Requirements for manufacturing facilities

A licensee shall provide:

1. Adequate lighting (at least 50 foot-candles), ventilation and screening and, if necessary for intended production or control purposes, facilities for adequate control of air pressure, microbiological contamination, dust, humidity and temperature in order to:

(a) Minimize contamination of products by extraneous adulterants, including cross-contamination of one product by dust or particles of ingredients arising from the manufacture, storage or handling of another product;

(b) Minimize dissemination of microorganisms from one area to another; and

(c) Maintain suitable conditions for storage of drug components, materials in process and finished drugs in conformance with information on stability derived pursuant to NAC 585.530.

2. Near working areas adequate locker facilities and hot and cold water washing facilities, including soap or detergent, air drier or single service towels and clean toilet facilities.

3. An adequate supply of potable water under continuous positive pressure in a plumbing system free of defects that could cause or contribute to contamination of any drug. Drains must be of adequate size and, where connected directly to a sewer, must be equipped with traps to prevent back siphonage.

4. Suitable housing and space for the care of all laboratory animals.

5. For the safe and sanitary disposal of sewage, trash and other refuse within and from the buildings and immediate premises.

Nev. Admin. Code § 585.300

Comm'r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 3.1.2-3.1.6, eff. 5-15-78

NRS 585.210, 585.245, 585.495