Compounding

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Today, the FDA issued a third revision of a draft guidance titled Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here).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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08
Jul

Just When you Thought it Was Safe to Come out of the Compounding Hood: Apparent Dearth of Evidence for the Effectiveness & Safety of Compounded Bioidentical Hormone Therapy

In late 2018, FDA entered a contract with the National Academies of Sciences, Engineering, and Medicine (the National Academies) to examine the clinical utility (effectiveness), safety and uses of compounded bioidentical hormone therapy (cBHT).  A high-level committee was formed and examined in detail the clinical utility of cBHT drug preparations, especially those containing estradiol, estrone, […]

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20
Apr

All Hands-On Deck – Pharmacy Compounding for Hospitals of Certain Drugs Approved in a Pinch

Early on Monday morning April 20, 2020, the FDA announced a relaxed policy for pharmacy compounders, if there is a shortage of certain drug products to treat COVID-19 patients that are not available through the normal supply chain or from a registered outsourcing facility. The guidance, titled Temporary Policy for Compounding of Certain Drugs for […]

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