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Compounding ALERT: USP Seeks Public Comments on Draft Revisions of Chapter <795>

For the first time, proposed revisions to USP General Chapter <795> will go through a public comment process. Comments can be submitted through a form on USP’s website no later than July 31, 2018. USP General Chapter <795> governs standards for non-sterile compounding pharmacies, describing the requirements for the compounding process, facilities, equipment, components, documentation, quality controls and training. Frier Levitt highly recommends commenting during this open public forum as these standards will...

Pharmacy Owner and Director of Compliance Charged with Defrauding United States and Distributing Adulterated Products

On Tuesday, June 20, 2017, Paul J. Elmer, pharmacist and owner of Pharmakon Pharmaceuticals Inc. (a 503B Outsourcing Facility), and Caprice R. Bearden, Pharmakon's Director of Compliance, were arrested and later indicted by a Federal Grand Jury in Indiana, charged with one count of conspiracy to defraud the United States and three counts of distributing adulterated products. According to FDA requirements, 503B Outsourcing Facilities must comply with current Good Manufacturing...

Need for Heightened Vigilance Illustrated by Pharmaceutical Manufacturer Mallinckrodt’s Settlement with DEA for $35 Million Based on Suspicious Orders

In an unprecedented settlement, Mallinckrodt, LLC, one of the largest pharmaceutical manufacturers of generic oxycodone, has agreed to pay Federal Drug Enforcement Agency (DEA) $35 million to settle allegations that they violated certain provisions of the Controlled Substance Act (CSA). The allegations included that Mallinckrodt failed to meet its obligations to detect and notify the DEA of suspicious orders of controlled substances, such as oxycodone, (a drug at the height...

DEA Clarifies Its Guidance Regarding Pharmacies Forwarding Unfilled Electronic Prescriptions

The Drug Enforcement Administration (DEA) recently clarified for pharmacists its guidance regarding forwarding unfilled electronic prescriptions (EPCS) for controlled substances. In an email from Loren Miller, an Associate Section Chief of the Drug Enforcement Administration, to Carmen Catizone, CEO of the National Association of Boards of Pharmacy (NABP), Loren stated, "The DEA published information in the preamble of the notice of proposed rulemaking (NPRM) on EPCS, 73 FR 36722, and...

340B Final Rule Pushed Back Once Again to July 2018

The Department of Health and Human Services (HHS) has once again delayed the 340B final rule which would penalize pharmaceutical manufacturers that knowingly overcharge hospitals beyond the ceiling price for drugs purchased through the program. HHS has now decided to delay the final rule until July 2018. Filed on August 17, 2017, HHS states that the delay has been proposed in order to allow more time to consider alternative and...