059-8 Wyo. Code R. § 8-13

Current through April 27, 2019
Section 8-13 - General Minimum Requirements of Facilities Storing and Handling Prescription Drugs

The following are required for the storage, handling, transport and shipment of prescription drugs and for the establishment and maintenance of records:

(a) All facilities at which prescription drugs are received, stored, warehoused, handled, held, offered, marketed, transported from or displayed shall:

  • (i) Be of suitable size and construction to facilitate cleaning, maintenance and proper operations to ensure that all prescription drugs in the facilities are maintained in accordance with the product labeling or in compliance with official compendium standards such as the United State Pharmacopeia-USP-NF;
  • (ii) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment and security conditions;
  • (iii) Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded or adulterated, counterfeit, or suspected of being counterfeit, otherwise unfit for distribution or wholesale distribution, or that are in immediate or sealed secondary containers that have been opened prior to receipt by the entity;
  • (iv) Be maintained in a clean and orderly condition;
  • (v) Be free from infestation of any kind;
  • (vi) Be a commercial location and not a personal dwelling or residence;
  • (vii) Provide for the secure and confidential storage of all information with restricted access and policies and procedures to protect the integrity and confidentiality of the information; and
  • (viii) Provide and maintain appropriate inventory controls in order to detect and document any theft, counterfeiting, or diversion of prescription drugs.

(b) All entities involved in the wholesale distribution of controlled substances shall be duly registered with the Drug Enforcement Administration (DEA) and the Board and in compliance with all applicable laws and rules for the storage, handling, transport, shipment and distribution of controlled substances.

059-8 Wyo. Code R. § 8-13

Amended, Eff. 10/31/2017.