Compounding

17
Feb
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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03
Nov
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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06
Oct
Hospital

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Today, the FDA issued a third revision of a draft guidance titled Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here).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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10
Aug

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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23
Mar

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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29
Oct

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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03
Aug

History of the 503B Bulk Drug Substance List – We’ve Come A Long Ways in a Long Time….and the List Is Getting Longer and Longer?

As part of the Agency’s ongoing efforts to ensure patient’s access to drugs, FDA is continuing to develop and evaluate a list of bulk drug substances that 503B Outsourcing Facilities can use in compounding, when it has been determined that there is a clinical/medical need that can’t be met by an available FDA-approved drug.  On […]

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30
Jul
Wooden Blocks with the text: Fees

Outsourcing Facility Fee Rates for Fiscal Year 2021

Outsourcing facilities are compounding facilities defined under section 503B of the Federal Food Drug and Cosmetic Act (FD&C Act).  There are yearly fees associated with establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the FD&C Act.  The FDA has Just published the fees for […]

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