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Oklahoma Administrative Code (Last Updated: March 11, 2021) |
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TITLE 535. Oklahoma State Board of Pharmacy |
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Chapter 20. Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third- Party Logistics Providers, and Medical Gas Suppliers and Distributors |
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Subchapter 6. Outsourcing Facilities |
SECTION 535:20-6-7. Compliance with federal, state and local laws
Latest version.
- (a) An outsourcing facility 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: and meet the requirements of Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act or any revision to the document as finalized.(b) An outsourcing facility 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) An outsourcing facility 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) When shipping to licensees, an outsourcing facility shall ship only to the address listed on the licensee's license.