Since the new United States Pharmacopeia (USP) guidelines went into effect on November 1, 2023, I have been receiving many inquiries regarding their impact on compounders. Because the changes are fairly recent, compounders want to know how and when they must be fully compliant, what enforcement vehicles are in the government arsenals, and what types
Compounded medications have been under government radar for quite some time. So a recent inditement and prosecution of two pharmacists and a marketer implicated in allegedly fraudulent scheme involving compounded medications comes as no surprise. The individuals allegedly defrauded TRICARE and private insurances by:
According to the most recent federal decision on the topic, state regulations of outsourcing facilities are not preempted by federal law. And therefore, facilities should comply with both.
The state-preemption challenge was brought by a federally-registered outsourcing facility against California on a ground that it denied its application under certain pharmacy-related regulations. Namely, a California
Recently a case was decided against an independent pharmacy and in favor of Express Scripts (ESI) holding that a PBM could terminate a pharmacy for misrepresenting information on its re-credentialing application.
To summarize, Express Scripts (ESI) terminated HM Compounding pharmacy from its pharmacy provider network for misrepresenting during a re-credentialing process that it never waived
A new report released by the U.S. Health and Human Services (Office of the Inspector General, “OIG”) expresses government’s concern about potential fraud and patient safety risks from compounded products used to treat pain. Medicare spending for such products has skyrocketed.
The OIG is currently investigating or plans to investigate pharmacies compounding and dispensing topical
In its recent guidance “Evaluation of Bulk Drug Substances Nominated for Use in Compounding” for outsourcing facilities, FDA again prioritized the use of FDA-approved drugs over more risky, custom-made medicines produced in bulk.
The guidance limits the raw substances that outsourcing facilities can use to make medicines in bulk that do not go through