§ 4081
379 words·~2 min read·
/ca/business-and-professions-code/4081A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)All records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices shall be at all times during business hours open to inspection by authorized officers of the law, and shall be preserved for at least three years from the date of making. A current inventory shall be kept by every manufacturer, wholesaler, third-party logistics provider, pharmacy, veterinary food-animal drug retailer, outsourcing facility, physician, dentist, podiatrist, veterinarian, laboratory, licensed correctional clinic, as defined in Section 4187, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration, or exemption under Division 2 (commencing with Section 1200) of the Health and Safety Code or under Part 4 (commencing with Section 16000) of Division 9 of the Welfare and Institutions Code who maintains a stock of dangerous drugs or dangerous devices.
(b)The owner, officer, and partner of a pharmacy, wholesaler, third-party logistics provider, or veterinary food-animal drug retailer shall be jointly responsible, with the pharmacist-in-charge, responsible manager, or designated representative-in-charge, for maintaining the records and inventory described in this section.
(c)The pharmacist-in-charge, responsible manager, or designated representative-in-charge shall not be criminally responsible for acts of the owner, officer, partner, or employee that violate this section and of which the pharmacist-in-charge, responsible manager, or designated representative-in-charge had no knowledge, or in which they did not knowingly participate.
(d)Pharmacies that dispense nonprescription diabetes test devices pursuant to prescriptions shall retain records of acquisition and sale of those nonprescription diabetes test devices for at least three years from the date of making. The records shall be at all times during business hours open to inspection by authorized officers of the law.
(1)In addition to the records described in subdivision (a), records that shall be maintained include policies and procedures related to pharmacy personnel and pharmacy operations. Such records shall be maintained in a readily retrievable format.
(2)Records described in paragraph
(1)that are maintained electronically shall provide an audit trail for revisions and updates of each record.
(3)Prior versions of each electronically maintained record described in paragraph
(2)shall be maintained in a readily retrievable format and include changes to the document, identification of the individual who made the change, and the date of each change.