Compounded Drug Surveillance – Mitigation of Risk Is the Payoff

Yesterday, the FDA published a web page entitled, Mitigating Risks of Compounded Drugs Through Surveillance (here)  which provides an overview of FDA’s Compounding Incidents Program.  It discusses how the program works in evaluating reports of adverse events and a broad range of drug product quality complaints and what the outcomes can occur based on the […]

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Compounding Committee to Evaluate Addition of 4 New Ingredients

The FDA’s Pharmacy Compounding Advisory Committee will be considering the addition of four new ingredients for use for inclusion on the bulk list for 503A compounders to utilize in the compounding of prescription drug products.  The four ingredients up for consideration are: Ammonium tetrathiomolybdate; Enclomiphene citrate; Ferric subsulfate; and Glutathione The Notice for the Advisory […]

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Caution Tape

Potential Serious Risks Associated with Compounded Nasal Ketamine

The FDA is warning healthcare professionals of potential risks associated with compounded ketamine nasal spray (here).  The Agency states that there is no approved ketamine nasal spray.  Hey, wait a minute! (you might say); I could have sworn that I read about a ketamine nasal spray approval?  Well, close!  The product you may be thinking […]

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Angry old couple in quarrel

The 5% Compounding Rule is Coming to a Head

On November 2, 2021, FDA posted an update to the Memorandum of Understanding (MOU) Addressing Certain Distributions of Compounded Drugs (here).  FDA notes that it was sued by seven compounding pharmacies (503A compounders) in US District Court regarding the 5% limitation on the out of state distribution of compounded products by pharmacies in states that […]

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FDA Issues Revised Guidance on Hospital and Healthcare Systems Compounding

Today, the FDA issued a third revision of a draft guidance titled Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here).  The Agency revised this guidance, which was previously revised in June 2016, in response to comments submitted to that document.  The revised document describes how and […]

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Limited, Inordinate, and Extended Can Kicking?

On 8/6/2021, a Federal Register Notice (here) was issued announcing an extension of the period before FDA intends to begin enforcing the statutory 5 percent limit on out of state distribution of compounded human drug products. FDA is extending the period for states to decide whether to sign the final MOU, (“Memorandum of Understanding Addressing […]

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Like the NBA -The Draft of Five (5) Bulk Drug Products Reviewed, but Only One Selected to Compete in the Big Arena

The FDA reviewed five (5) bulk drug substances for inclusion in the bulk APIs that can be used by outsourcing facilities in the compounding of drug products.  The five (5) nominated for consideration were: quinacrine HCl, bromfenac sodium, mitomycin–C, nepafenac, and hydroxychloroquine sulfate.  Only quinacrine HCL for compounding for oral products for the treatment of […]

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Along with Witches, Time Flies By

How long has it taken for a Final Standard Memorandum of Understanding (MOU) for States regarding Compounding Pharmacies to be issued?  Are States or appropriate agencies (referred to as States below) ready to sign, acquire infrastructure, hire the necessary human resources, develop the enabling documentation, execute the requirements of the provisions, create the necessary records, […]

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