Mont. Admin. r. 24.174.1211 - MINIMUM FACILITY REQUIREMENTS

(1) All facilities licensed under this subchapter shall:

(a) establish, maintain, and adhere to written policies and procedures for receipt, recordkeeping, security, storage, inventory control, and distribution of drugs or devices;

(b) comply with state and federal law requirements including, but not limited to:

(i) 37-7-602, 37-7-604, 37-7-609, and 37-7-610, MCA; and

(ii) 21 CFR - 205 as established by the Food and Drug Administration (FDA); and

(c) comply with product track and trace transaction requirements established by the FDA.

(2) Inventories and records shall be made available for inspection and photocopy by authorized federal, state, or local law enforcement agency officials for a period of two years following distribution of inventory.

(3) Records described in this subchapter that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at central locations apart from the inspection site and not electronically retrievable shall be made available for inspection within two working days of a request by an authorized official of a federal, state, or local law enforcement agency.

Notes

Mont. Admin. r. 24.174.1211

NEW, 1992 MAR p. 2135, Eff. 8/14/92; TRANS, from Commerce, 2002 MAR p. 904; AMD, 2006 MAR p. 1615, Eff. 6/23/06; AMD, 2022 MAR p. 1842, Eff. 9/24/2022

AUTH: 37-7-201, 37-7-610, MCA; IMP: 37-7-604, 37-7-610, MCA