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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FDA to Drug Compounders: Inspection Changes Coming in August | RAPS

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Updated October 8, 2022

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Human Drug Compounding - FDA.gov

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Read the full article: FDA to Drug Compounders: Inspection Changes Coming in August | RAPS:

"For companies that compound human drugs in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B), effective 1 August 2016, “FDA investigators will make a preliminary assessment of whether such entities are compounding their human drugs in accordance with certain conditions of section 503A before closing the inspection.”"

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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 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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