Audits & Investigations

       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

Last week the U.S. Department of Justice (DOJ) announced its largest settlement with a drug distributor – AmerisourceBergen (ABC) – in the combined amount of $885 million.

ABC, through its Pre-Filled Syringe Program, allegedly caused numerous false claims to be submitted to the federal healthcare programs (1) for unapproved new drugs; (2) for drugs

Many pharmacies and clinics run background checks on their employees to assure that individuals have not been excluded from any federal health care program. Most healthcare providers incorporate this procedure into their Policies & Procedures requiring to check the OIG’s List of Excluded Individuals/Entities, as well as state databases before any employment decision is made.

Walmart and Sam’s Club have agreed to pay $825,000 to resolve allegations that they have violated the False Claims Act by automatically refilling Medicaid prescriptions. The allegations came from the state of Minnesota, which – as many other states – does not allow automatic refill of Medicaid prescriptions without an explicit request from the beneficiary