FDA Announces Inspection Procedure Change for 503A Compounders | Frier Levitt - Attorneys at LawFrier Levitt – Attorneys at Law

Read the full article: FDA Announces Inspection Procedure Change for 503A Compounders | Frier Levitt - Attorneys at LawFrier Levitt – Attorneys at Law:

"Effective August 1, 2016, FDA investigators now will make a preliminary assessment regarding a compounder’s compliance with conditions of section 503A and will not include observations that represent deviations solely from CGMP requirements unless the investigator’s assessment is that the compound drugs do not qualify for the exemptions under section 503A."

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Read the details of the FDA Notice (PDF)

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FDA Gives Guidance On Compounding For Human Use - mondaq

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Updated April 19, 2022

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Compounding Quality Center of Excellence On-demand Training - FDA.gov

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Read the full article: FDA Gives Guidance On Compounding For Human Use - Food, Drugs, Healthcare, Life Sciences - United States - mondaq:

"In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human use. These documents are:

• Draft Interim Guidance setting forth FDA's current thinking as to its interim expectations for outsourcing facilities regarding compliance with Current Good Manufacturing Practices (CGMP) until regulations are developed; 
• A Proposed Rule adding 25 new drug products to the "do-not-compound" list, for both traditional compounders and outsourcing facilities; 
• Final Guidance for traditional compounders; and 
• Two separate requests, one for 503A and one for 503B, to nominate bulk drug substances for FDA lists of active bulk substances that traditional compounders and outsourcing facilities are permitted to use."

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FDA Prepares Compounding Blacklist of Banned Products - RAPS RF

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FDA Prepares Compounding Blacklist of Banned Products - RAPS RF:

"In a Federal Register announcement on 2 December 2013 — just days after the DQSA was signed into law — FDA said it wanted public input on which drugs should comprise such a list.

"To identify candidates for the difficult-to-compound list, FDA is seeking public input in the form of specific drug products or categories of drug products that are difficult to compound," the agency wrote."

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FDA aims to oversee drug compounders - USA Today

FDA aims to oversee drug compounders - USA Today:

""We will be encouraging health care providers and health networks to consider strongly purchasing compounded products from FDA-registered and regulated facilities," FDA Commissioner Margaret Hamburg says. "This will be a critical step they can take to better assure the health and safety of their patients."

Outsourcing facilities will also be required to report specific information about the products they compound, including a list of all the products compounded during the previous six months, and details about the source of the active ingredient, as well a report known as adverse effects."

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