Tag Archives: compounding pharmacies

FDA Committee to Continue Considering Drug Compounding Issues

The advisory committee tasked with providing advice on medical, scientific and technical issues to the Food and Drug Administration (FDA) on compounded drugs is slated to continue its examination of matters concerning access to investigational new drugs and what components can be used in compounded products, among other topics. The FDA’s Pharmacy Compounding Advisory Committee … Continue Reading

Compounding Pharmacies Protected by Medical Liability Act

In a court decision holding that a compounding pharmacy is entitled to certain protections against medical malpractice claims, the Supreme Court of Texas established a precedent that may well prove valuable to pharmacists facing lawsuits stemming from compounded drugs. The court ruled that claims brought by a patient who allegedly suffered serious injuries as a … Continue Reading

FDA Establishes Docket for Public Comments on Drug Compounding

The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA hopes that these public comments will provide insight on stakeholders’ experience and views regarding drug compounding as the … Continue Reading

FDA Issues Draft Memorandum of Understanding for 503A Drug Compounding

Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate distribution of prescription compounded drugs—a Draft Memorandum of Understanding (MOU) between the FDA and each of the 50 states. As previously discussed, … Continue Reading

FDA Guidance Documents Change Compounding Landscape

Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug compounding, the Food and Drug Administration (FDA) continues to roll out guidance documents detailing its view on assorted issues concerning implementation of the statute. The FDA’s most recent offering is … Continue Reading

Now’s the Time to Comment on the FDA’s New Draft Documents on Compounding Policy

The U.S. Food and Drug Administration (FDA) has released five new draft documents related to drug compounding and repackaging by “outsourcing facilities,” state-licensed pharmacies, federal facilities and other healthcare entities. These documents are the latest in a series of policy guidance, including the documents released in July 2014 and December 2014, issued as part of the … Continue Reading

New Guidance for 503B Outsourcing Facilities

Three guidance documents recently issued by the Food and Drug Administration (FDA) provide greater clarity for certain entities that compound sterile drugs. The new guidance addresses registration requirements, fees and drug reporting requirements for those entities registered as outsourcing facilities under Section 503B of the Federal Food, Drug and Cosmetic Act (FFDCA). Congress amended the … Continue Reading

Pharmacy Benefit Manager Faces Lawsuit by Compounding Pharmacies

In response to a decision to deny coverage of approximately 1,000 active ingredients that are widely used by compounding pharmacies to create topical treatments, three compounding pharmacies have filed a lawsuit against the pharmacy benefit manager (PBM) at the center of the dispute. The lawsuit alleges that Express Scripts is illegally denying prescriptions and causing … Continue Reading

Implications on Pharmacies of Recent OIG Advisory Opinion on Per-Fill Fees

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued an advisory opinion regarding a proposed arrangement by a specialty pharmacy (Requestor) to pay local pharmacies a per-fill fee for the provision of support services in connection with patient referrals to the specialty pharmacy. OIG found that this per-fill fee … Continue Reading

Compounded Drugs and Medicare Part B: OIG Report Recommends Payment and Oversight Changes

The U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently published a report titled “Compounded Drugs Under Medicare Part B: Payment and Oversight” (Report) in which it recommended that the Centers for Medicare & Medicaid Services (CMS) implement changes to the way Medicare Part B claims for compounded drugs … Continue Reading

FDA Releases Compounding Policy Documents

The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, as … Continue Reading

Stop the Presses! Senate Directs FDA to Meet With Stakeholders Before Enforcing Compounding Law

As previously discussed, the recent flurry of U.S. Food and Drug Administration (FDA) activity following passage of the Drug Quality and Security Act (DQSA) in November 2013, including the issuance of three draft guidance documents and six warning letters in the span of just a few months, has resulted in several important unanswered questions as … Continue Reading

FDA Regulation of Compounding Pharmacies: Unsolved Mysteries

The U.S. Food and Drug Administration (FDA) has been busy since the passage of the Drug Quality and Security Act (DQSA) in November 2013. In just five short months, the FDA has issued six warning letters referencing the DQSA’s outsourcing facility provisions, published three draft guidance documents outlining its authority and enforcement priorities under Sections … Continue Reading
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