Audits & Investigations

While this is not a new case, nevertheless it must be revisited to remind the importance of verifying all licensure, credentials, and records of pharmacy employees. This straightforward and easy step could potentially save pharmacies millions of dollars, as this case and many enforcement actions illustrate.

Earlier this year, Walgreens agreed to pay $7.5 million

Many prescribers’ offices are closed due to the coronavirus outbreak, leaving many pharmacies unable to obtain fill authorizations for patients.

Under California law, pharmacies may refill prescriptions without prescriber authorization if:

  • the prescriber is unavailable to authorize the refill;
  • in the pharmacist’s professional judgment, failure to refill the prescription might interrupt the patient’s ongoing

Do you purchase test strips from suppliers authorized by manufacturers to distribute these products? If not, you may face significant chargebacks and contractual termination when PBMs audit your pharmacy’s test strips invoices.

Virtually all PBM  require test strips to be purchased from the suppliers expressly authorized by manufacturers to distribute their products. Most PBM manuals

       The California State Board of Pharmacy has published an inspection checklist to guide pharmacies on what to inspect during an inspection.

The brochure elaborates on the process to be followed by the inspector. For example, the inspector must provide the pharmacy with:

  • a business card;
  • a receipt for any records taken from the premises;

    Despite many articles, seminars, and educational opinions written on compliance and legal implications of dispensing, ordering, and storing controlled substances, it still remains the number one reason for disciplinary actions across the nation. This article focuses on the most cited violations of state or federal laws pertaining to working with the controlled substances.

  1. Improperly performed

 In 2015, the owner and pharmacist-in-charge of Lane Pharmacy passed away. The Pharmacy, however, carried on as nothing had happened. Allegedly, the Pharmacy continued to operate without a pharmacist. This “unusual” Pharmacy operated until 2017, when the California Board of Pharmacy received a complaint that non-licensed individuals were dispensing medications. The Board investigation revealed that

The FDA has issued its first warning letter under the Drug Supply Chain Security Act (DSCSA) to McKesson Corp. for tampering with opioid medications.

The FDA said the distributor didn’t address several instances of reported drug tampering for medications including opioids and treatments for HIV, seizures, bipolar disorder and high blood pressure.

The warning letter