Montana Code 37-7-609. Board access to records
37-7-609. Board access to records. Wholesale distributors, third-party logistics providers, manufacturers, and repackagers may keep records at a central location apart from the principal office of the wholesale distributor , third-party logistics provider, manufacturer, and repackager or the location where the drugs are stored and from where they are shipped, if the records are available for inspection within 2 working days of a request by the board. The records may be kept in any form permissible under federal law applicable to prescription drug recordkeeping.
Terms Used In Montana Code 37-7-609
- Board: means the board of pharmacy provided for in 2-15-1733. See Montana Code 37-7-101
- Drug: means a substance:
(a)recognized as a drug in any official compendium or supplement;
(b)intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
(c)other than food, intended to affect the structure or function of the body of humans or animals; and
(d)intended for use as a component of a substance specified in subsection (16)(a), (16)(b), or (16)(c). See Montana Code 37-7-101
- Manufacturer: means :
(a)a person approved by application to the FDA to manufacture a product as defined in section 360eee of the Drug Supply Chain Security Act, 21 U. See Montana Code 37-7-602
- Repackager: means a person who owns or operates an establishment that repacks and relabels a product or a package for:
(a)further sale; or
(b)distribution without a further transaction. See Montana Code 37-7-602
- Wholesale: means a sale for the purpose of resale. See Montana Code 37-7-101
- Wholesale distributor: means a person or entity, other than a manufacturer, a manufacturer's colicensed partner, a third-party logistics provider, or a repackager, who is engaged in wholesale distribution of prescription drugs. See Montana Code 37-7-602