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Uh Oh, A Controlled Substance Bottle Spilled or Broke. Now What?

epicur

Have you ever broken or spilled a bottle of a controlled substance? 5 Reminders for Properly Documenting a Spilled or Broken Bottle of a Controlled Substance A spill or breakage does not constitute a loss because the registrant can account for the controlled substance. If so, did you document it?

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The discovery of a new and compounding cybersecurity threat to pharmacies

pharmaphorum

One, someone who should not be able to get their hands on these controlled substances can. Criminals gaining access to controlled substances by simply picking them up at pharmacies is incredibly problematic, especially considering the massive and ongoing opioid crisis.

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Pharmacies Selling PSE: Remember to Train Employees and Self-Certify

FDA Law Blog: Biosimilars

Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). 16, 2023 ( DOJ Press Release ).

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Psychedelic research: evaluating the fast-evolving regulatory roadmap

European Pharmaceutical Review

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured.

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Cannabinoids receptors: popular preclinical target but banned in 137 countries

Pharmaceutical Technology

Cannabinoid-based drugs are derived from compounds found in the cannabis plant. However, at the federal level, cannabinoids remain illegal under the Controlled Substances Act. Despite this, the medical use of cannabinoid drugs is heavily restricted, including being banned in 137 countries, according to the United Nations.

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Protecting Public Health through Accreditations and Inspections 

National Association of Boards of Pharmacy

The major components that the team looks for during a site visit are: controlled substance security, temperature control, cleanliness, business continuity and disaster planning, and who the business is buying from and selling to.

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Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law Blog: Biosimilars

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA. 21 U.S.C. §