Bulk Drugs for Use in Compounding by 503B Compounders – Score: +2, -3

Outsourcing compounding facilities are those that register with the FDA as such under section 503B of the Federal Food Drug and Cosmetic Act.  According to the FDA, “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is […]

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Close-up medical syringe with a vaccine.

Compounders of Sterile Products Remain on FDA’s Radar

In the past six (6) months, FDA has issued two (2) Alerts (here and here), for patients and caregivers to not use sterile products manufactured by the two companies cited in the alerts. One company compounds product for human patients, and the other for veterinarians and animals (pet owners, beware). In that same 6-month period, […]

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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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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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flying money

Out of Sight – Out of Mind – Not Hardly and No Refunds

FDA issues Guidance for Industry: “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act, April 2020”. With all that’s going on with Covid-19, FDA is diligently executing their priorities for this fiscal year.  In FY19, FDA’s priorities for Compounding (human drugs) were to: maintain quality manufacturing and compliance; […]

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