Records Requirements

PURPOSE: This rule defines the record keeping and inventory requirements for various classes of registrants. (1) Persons Required to Keep Records. (A) Each registrant shall maintain the records and inventory required by 19 CSR 30-1.041–19 CSR 30-1.052, except as exempted by 19 CSR 30-1.041–19 CSR 30-1.052. (B) Registered individual practitioners and institutional practitioners are required to keep records with respect to controlled substances which are prescribed, administered or dispensed. (C) A registered person using any controlled substance in research conducted in conformity with an exemption granted under section 505(i) or 512(j) of the federal Food, Drug and Cosmetic Act (21 U.S.C. 355(i) or 360(j)) at a registered establishment which maintains records in accordance with either of those sections is not required to keep records if s/he notifies the Department of Health of the name, address and registration number of the establishment maintaining these records. (D) A registered person using any controlled substance in preclinical research or in teaching at a registered establishment which maintains records with respect to these substances is not required to keep records if s/he notifies the Department of Health of the name, address and registration number of the establishment maintaining the records. (E) Notice required by subsection (1)(D) of this rule shall be given at the time the person applies for registration or reregistration and shall be made in the form of an attachment to the application, which shall be filed with the application. (2) Maintenance of Records and Inventories. Every inventory and other record required to be kept under 19 CSR 30-1.041–19 CSR 30-1.052, shall be kept by the registrant and be available, for at least two years from the date of the inventory or record, for inspecting and copying by authorized employees of the Department of Health, except that financial and shipping records (such as invoices and packing slips, but not executed order forms) may be kept at a central location rather than at the registered location if the registrant obtains from the Department of Health approval of his/her central record keeping system and a permit to keep central records. The permit to keep central records shall be subject to the following conditions: (A) The permit shall specify the nature of the records to be kept centrally and the exact location where the records will be kept; (B) The registrant agrees to deliver all or any part of these records to the registered location within three working days of receipt of a written request from the Department of Health for these records and if the Department of Health chooses to do so in lieu of requiring delivery of records to the registered location, to allow authorized employees of the Department of Health to inspect the records at the central location upon request by the employees without a warrant of any kind; (C) The failure of the registrant to perform his/her agreements under the permit shall revoke, without further action, the permit and all other such permits held by the registrant under other registrations. In the event of a revocation of other permits under subsection (2)(C) of this rule, the registrant, within 30 days after the revocation, shall comply with the requirement that all records be kept at the registered location. (3) Each registered individual practitioner, institutional practitioner, manufacturer, distributor, importer and exporter shall maintain inventories and records of controlled substances as follows: (A) Inventories and records of controlled substances listed in Schedules I and II shall be maintained separately from all of the records of the registrant; (B) Inventories and records of controlled substances listed in Schedules III, IV and V shall be maintained either separately from all other records of the registrant or in a form that the information required is readily retrievable from the ordinary business records of the registrant. (4) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows: (A) Inventories and records of all controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy and prescriptions for these substances shall be maintained in a separate prescription file; (B) Inventories and records of controlled substances listed in Schedules III, IV and V shall be maintained either separately from all other records of the pharmacy or in a form that the information required is readily retrievable from ordinary business records of the pharmacy and prescriptions for those substances shall be maintained in a separate prescription file. AUTHORITY: sections 195.050 and 195.195, RSMo 1994 and 195.030, RSMo Supp. 1999.* Original rule filed April 14, 2000, effective Nov. 30, 2000. *Original authority: 195.030, RSMo 1939, amended 1971, 1989, 1993, 1997, 1999; 195.050, RSMo 1939, amended 1971, 1989; and 195.195, RSMo 1957, amended 1971, 1989, 1993.