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Friday, March 1, 2024

PillPack by Amazon to Pay $300,000 to Settle Alleged Controlled Substances Act Violations

DEA investigators found that PillPack’s records did not accurately reflect its inventory for ten Schedule III-V substances.

U.S. Attorney Jane E. Young announces today that PillPack, LLC dba PillPack by Amazon Pharmacy (PillPack) will pay $300,000 to resolve allegations that it violated the Controlled Substances Act (CSA) by failing to keep accurate records of controlled substances.

In 2020, the Drug Enforcement Administration (DEA) began investigating PillPack for potential violations of the CSA, and in October of 2020 conducted an audit of PillPack, which revealed recordkeeping deficiencies.  Specifically, DEA investigators found that PillPack’s records did not accurately reflect its inventory for ten Schedule III-V substances: Codeine #4, Tramadol, Zolpidem, Butalbital, Alprazolam, Acetaminophen with Codeine #3, Clonazepam, Lorazepam Carisoprodol, and Lyrica.

“PillPack’s failure to maintain accurate records risked the diversion of drugs that are often abused in our communities,” said U.S. Attorney Jane E. Young. “As a pharmacy, they have a responsibility to safeguard these controlled substances, and their penalty for failing to do so, serves as a warning to other entities handling medications improperly.”

“The DEA is committed to ensuring that all registrants are in compliance with the required regulations, which are enforceable through the Controlled Substances Act,” said Special Agent in Charge Brian D. Boyle.  “When a pharmacy like PillPack fails to comply, that increases the potential for diversion and puts the safety of the public in jeopardy.  DEA pledges to work with our law enforcement and regulatory partners to ensure these rules are followed.”

The CSA deters the illegal distribution, possession, dispensing, and improper use of controlled substances. The CSA requires the accurate inventorying, tracking and recordkeeping of each controlled substances to prevent misuse.

The Drug Enforcement Administration led the investigation leading to the settlement agreement. The case was handled by Assistant U.S. Attorney Raphael Katz.

The claims resolved by the settlement are allegations only, and there has been no determination of liability.

Read more at the Justice Department

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