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Demonstrably Difficult to Compound List Proposed Rule Issued by FDA – Will Compounders Balk?

The FDA has been working with the Pharmacy Compounding Advisory Committee (PCAC) since the year 2000 to develop a list of drug products that present demonstrable difficulties for compounding.  Concerns relative to bioavailability, variations in batch-to-batch consistency, and dosage-form release characteristics that could present significant safety (or other) issues are outlined in and provide a […]

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CARES ACT – 2024 Update – Big News!

Since the implementation of the CARES Act reporting requirement, the question continues to be asked: Is it really a requirement?  The answer is yes, and now it is no longer recommended, but is stated as “should” in the newly published Final version of the Guidance for Industry (GFI) “Reporting Amount of Listed Drugs and Biological […]

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The Eyes Have it - Lachman Consultants Blog

The Eyes Have it!

On December 27, 2023, the FDA released a revised draft version of its October 2023 guidance titled Quality Considerations for Topical Ophthalmic Drug Products: Guidance for Industry. This revised draft, of the same name, outlines most of what was covered in the October draft guidance; however, it does include some clarifications and some additional information. The […]

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More History of the 503B and 503A Bulk Drug Substance Lists Significant and Welcomed Changes_LachmanBlog

More History of the 503B and 503A Bulk Drug Substance Lists: Significant and Welcomed Changes?

Last week, the FDA has announced the availability of two draft Guidances for Industry regarding compounding of human drugs: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (here); and Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and […]

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FDA Issues New Guidance for Methanol Testing in Pharmaceutical Alcohols

On the heels of additional reports of methanol poisoning from ingestion of hand sanitizers, the FDA issued a new final guidance titled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol (here) for immediate implementation. The guidance applies to the use of pharmaceutical alcohols (PAs) (ethanol and isopropyl alcohol) by pharmaceutical manufacturers, outsourcing […]

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Compounding - What About the Birds and the Queen Bees and Our Furry Friends

Compounding – What About the Birds and the Queen Bees and Our Furry Friends?

In a recent issue of a veterinary journal, vaccines for bees (for American Foul Brood – AFB) made the headlines. Veterinarians would oversee administering the vaccine and possibly in “compounding” the vaccine for specific queen bees. Honeybees are food animals because they produce honey for human consumption and because they have a role in crop […]

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New ISPE Guide on 503B Compounding

For those struggling with understanding all the complexities of running a 503B compounding facility, a new resource is now available. The International Society of Pharmaceutical Engineers (ISPE) has a new guide coming out titled “503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities” (here). Do you know why compounding exists? Shouldn’t all […]

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Two Bulk Drug Substances Are Denied for Inclusion on Bulk Drug List for 503B Compounders

In a Federal Register Notice, FDA explains that ephedrine sulfate and hydroxychloroquine sulfate are not to be included on the bulk drug list for use in compounding by 503B outsourcing facilities (here). As mentioned by the Agency “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to […]

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FEES CHARGED - words on calculator.Money in hand and office supplies

503B Outsourcing Inspection Fees for 2024 Just Released

The Food and Drug Administration (FDA) has announced the fiscal year (FY) 2024 rates for the establishment and reinspection fees related to entities (503B registered facilities)” that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  The FD&C Act authorizes FDA to assess and […]

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Wholesaling by 503B Outsourcing Facilities - Lachman Consultants

What Constitutes Wholesaling by 503B Outsourcing Facilities?

The FDA released a guidance yesterday titled Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (here), which (as its title suggests) fully outlines what the Agency does and does not consider wholesaling by an outsourcing facility.  The examples of what a firm can and cannot do under the provisions of […]

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