Oklahoma Board of Pharmacy INFORMATION REGARDING USP 800 RULES

INFORMATION REGARDING USP 800 RULES

USP 800 Rules were passed by the legislature this year, but the rules were not sent to the publisher and therefore are not going into effect this year.  The Board Members approved these Rules in March 2019, but informed Board staff to not start enforcing them until July 1, 2021. 

This date is strictly in regards to OSBP Enforcement- Pharmacies with any type of accreditation should check with the accreditation body to verify specific compliance deadlines.  USP 800 Rules can be found on our website by using this link: (Starts on Page 10 of this document)

https://www.ok.gov/pharmacy/documents/CHAPTER%2015_2019_proposed%20permanent%20rules.pdf

As always, if you have any questions please contact the Board Office during normal business hours and ask to speak with a Compliance Officer.

Federal judge enters consent decree against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx, for drug, device and dietary supplement violations

A federal court has ordered two Tennessee-based companies and their owner to stop distributing drugs, dietary supplements and devices until the companies comply with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in a consent decree. According to the complaint filed with the consent decree, the defendants unlawfully distributed unapproved new drugs, adulterated and misbranded dietary supplements and an adulterated and misbranded device.  “Americans expect and deserve products that meet appropriate standards for quality. To ensure safe use by consumers, it’s important that companies who sell products adhere to standards set forth by the FD&C Act, including product labeling and quality,” said Acting FDA Commissioner Ned Sharpless, M.D. “Despite previous warnings, Basic Reset and Biogenyx placed consumers at risk by distributing certain products in violation of current good manufacturing practice (CGMP) requirements and products which failed to ...

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United States: OTC Personal Products Manufacturer Cited By FDA For Various Regulatory Violations

Duane Morris LLP

On August 20, 2019, the U.S. Food and Drug Administration announced that it had sent and posted a warning letter to an over-the-counter drug manufacturer citing "significant"