New 2 minute video on 503A vs 503B

There have been a few changes recently that might be leaving you a little confused about compounding.

Try out our 2 minute video below – we hope it makes things clearer.

Does the new FDA Guidance Doc GFI #256 affect me?

Probably not.
 

There has been a lot published about GFI #256 which went into effect this month. But how relevant is it to you?

GFI #256 does not apply to the following situations:

1. Purchasing for office-stock from an outsourcing facility (503B)

2. Prescribing for a specific patient and your 503A pharmacy is using an FDA approved product as the active ingredient

If that covers your needs – you can stop reading here.

 

When might it affect you:

a) The FDA approved product can’t be used
In a few cases you might have a medical reason to ask the compounding pharmacy to start with a bulk active ingredient rather than an FDA approved product. For example, rather than crushing a pill, they start with a pure powder that does not contain a filler that triggers an allergic reaction.

That would be considered by the FDA as a “copy” of an FDA approved product.

In this situation, the pharmacy will ask you to provide a brief medical rationale to explain why a copy is required. (eg: FDA product contains an active ingredient that the patient is allergic to.)

b) You are working with food-producing species or wildlife
The compounding pharmacy will also need to check if the bulk starting material requested is on the FDA’s approved lists for wildlife.


Note: GFI #256 also covers office-stock medications that are manufactured in a 503A pharmacy from bulk substances. But this is not relevant in New York. 503A compounding pharmacies in New York can only deliver medications where there is a patient-specific prescription. And 503B outsourcing facilities are outside the scope of GFI #256.