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- Facts About FDA's Guidance for Industry #256
- Why Compounding Pharmacies Use Bulk Active Pharmaceutical Ingredients
- Why Compounding from Finished Goods Will Increase Costs
- The Case for Office Use of Compounded Medications
- Anticipatory Compounding: An Important Part of Pharmacy Practice
- Pharmacy or Manufacturer? Size Doesn't Matter.
- The Negatives About FDA’s “Positive List.”
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Compounding
Facts About FDA's Guidance for Industry #256
Background
FDA’s Center for Veterinary Medicine (CVM) recently issued draft guidance (GFI #256) that, if finalized, threatens to have serious and damaging ramifications for your practice and your patients. You may recall in 2015, FDA introduced guidance (GFI #230) that was substantially similar on the compounding of animal drugs from bulk drug substances. Following significant pushback from the veterinary and pharmacy community and intervention from members of Congress, FDA formally withdrew that Guidance in 2017.
Why Compounding from Finished Goods Will Increase Costs
Why Forcing Compounding Pharmacies to Compound from Finished Pharmaceutical Goods Instead of Bulk Active Pharmaceutical Ingredients Will Cause a Dramatic Increase in the Cost of Vital Compounded Medications.
Why Compounding Pharmacies Use Bulk Active Pharmaceutical Ingredients
Why Compounding Pharmacies Use Bulk Active Pharmaceutical Ingredients from FDA-Registered Suppliers to Make Custom Medications—and Why That’s Best
Alert
Speak up for your patients who can't speak for themselves. There are two active campaigns that you can support today:
Pharmacy or Manufacturer? Size Doesn't Matter.
Proposed regulations intended to improve the safety of compounded medications often use quantity measurements as a “marker” for safety.
The more compounds prepared, these laws reason, the less safe the compounds. So, by this rationale, the quantity of compounds made by a compounder ought to be part of a formula that distinguishes between a “traditional compounder” and a “compounding manufacturer.”
The Case for Office Use of Compounded Medications
The prohibition of dispensing medication for office use, or the requirement that any pharmacy doing so must be regulated by the FDA against manufacturer-like standards, is most likely the result of misunderstanding this much needed—and in many states explicitly permitted—healthcare practice.