Pennsylvania Code
Title 28 - HEALTH AND SAFETY
Part III - Prevention of Diseases
Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
STANDARDS OF OPERATION FOR DRUG, DEVICE OR COSMETIC DISTRIBUTORS
Section 25.32 - Warehousing requirements
Current through Register Vol. 54, No. 44, November 2, 2024
(a) Establishments warehousing products which require refrigeration shall be equipped with adequate facilities for storage at the proper reduced temperatures.
(b) Distributors dealing in controlled substances shall have adequate storage facilities and safeguards to comply with the regulations of the Federal Drug Enforcement Administration.
(c) Distributors dealing in drugs shall have adequate storage facilities and safeguards to prevent loss or minimize deterioration.
(d) Each distributor's establishment shall provide for a systematic rotation of stock.
(e) Damaged, out-dated or otherwise unfit drugs, devices or cosmetics not in conformity with the provisions of the act or regulations thereunder, shall be removed from active stock and held for proper disposition in a quarantine or other clearly defined area.
(f) A distributor dealing in nonproprietary drugs or controlled substances shall have operating and storage facilities which have entrances used only by that distributor and which are separate from living quarters. Facilities shall be secured so that persons in an adjoining structure, business or residence cannot traverse through the operating and storage areas used for nonproprietary drugs or controlled substances.
The provisions of this §25.32 issued under section 35 of the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § 780-135); and section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).
