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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. Breakthrough therapy designation.

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How to spring clean your pharmacy

The Checkup by Singlecare

Control your controls If your biennial controlled substance inventory is due this year, now is the time to start preparing. Ensure all controlled substances are stored properly. For example, over-the-counter hearing aids are now FDA-approved—is your pharmacy stocked and ready?

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CDC Emphasizes Opioid Guideline is Voluntary and Should Support, Not Supplant, Patient Care

The FDA Law Blog

Before starting opioid therapy for subacute or chronic pain, clinicians should discuss with patients the realistic benefits and known risks of opioid therapy, should work with patients to establish treatment goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks.

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DEA’s Expected Guidance: It Should Reduce Current “Pain” at the (Intrathecal Pain) Pump Dispensing Process and Improve Therapeutic Outcomes

The FDA Law Blog

Palmer — For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion. A qualified medical professional must perform the refill; it cannot be done by the patient.