Oklahoma Administrative Code
Title 535 - Oklahoma State Board of Pharmacy
Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD)
Subchapter 3 - Manufacturers
Section 535:20-3-6.10 - Compliance with federal, state and local laws
Current through Vol. 42, No. 1, September 16, 2024
(a) A manufacturer shall operate in compliance with the Federal Food, Drug, and Cosmetic Act Good Manufacturing Practices, 21 U.S.C. §§ 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. §§ 216, 262, 263a, 264; and 21 C.F.R. Parts 210 and 211.
(b) A manufacturer shall operate in compliance with all applicable federal, state, and local laws and regulations, including, but not limited to, the Drug Quality and Security Act of 2013 and rules promulgated thereunder and the Act, 59 O.S. Section 353, et seq. and the Board's Rules, OAC 535.
(c) A manufacturer shall allow the Board and authorized federal, state, and local law enforcement officials to enter and inspect its premises and delivery vehicles, to audit its records and written operating procedures, and to confiscate prescription drugs and records to the extent authorized by law or rules.
(d) A manufacturer shall only ship to the address listed on the licensee's license.
Added at 25 Ok Reg 1772, eff 5-12-08 (emergency); Added at 26 Ok Reg 2296, eff 7-1-09
