Thank you for the opportunity to comment on Guidance Document 110-36

Regarding Question 5

Can the Board consider allowing pharmacies with common ownership to transfer compounded preparations among those stores if the company maintains a real time shared inventory database?

Physicians are really struggling to find compounded products to use at the chair level (see examples). The 503B pharmacies are not making these items to sell as office stock and the offices also do not want to get permits to store drugs. These are small amounts of items that are used for occasional patient procedures. There could be Qty limits if that helps ensure this doesn’t become “office stock”. Can the Board find regulatory language for non-sterile compounded preparations that allows us to help these patients while not breaking the FDA’s rules.

• Examples:

  • Sinus procedures - there is a need for anesthetic nasal sprays prior to scope or in office procedure. 

  • Otic powder that is sprayed into the ear canal after an ear is cleaned and an infection is suspected.

  • OB/Gyn, Derms and Dentists need anesthetic creams/sprays for exams, excisions, and other minor in office procedures.

Consideration to add additional questions:

Because of the new USP requirements the chain stores and independent pharmacies have abandoned compounding entirely. There are now towns where there is no access to what I call simple compounding. Consider making an allowance outside of full compliance with USP 795 for the mixing of manufactured products. For example a magic mouthwash formulation is a simple combination of 3-4 ingredients poured together. They are not hazardous to the person mixing and don’t require any specialized equipment. Another example is basic butt paste, or antifungal/steroid cream combinations. This allows for affordability and access for patients in a timely manner.

An awareness of USP 797 BUDs and testing implications:

As a compounding pharmacist with over 20 yrs experience in sterile compounding, I want to bring to your attention a hypothetical scenario that has patent safety concerns. The new guidelines allow Semaglutide to be compounded in a batch of 250 units. It is aseptically compounded, not terminally sterilized and can be given a 45 day frozen expiration date with NO testing required. Sterility is a probability principle, the larger the batch the more likely it can be contaminated. I would recommend that the board make an exception that is similar to the previous USP, that any batch over 24 units should be tested for sterility and endotoxins.   

Commentary:

Compounding is inherent to our profession, but the principle of working with a prescriber to make something specific for a patient has gone by the wayside. When a pharmacist's discretion combined with research and published data is thrown out, our profession is diminished. Requiring stability indicating assays that cost $50,000+ per formulation is just plain wrong for formulations that have been listed for years in resources like Trissels and the Pediatric Handbook.

Overall, my ask related to this document, but not directly addressed in the questions, is to consider an addendum to the USP; thereby allowing safe and accessible medications to our VA residents. Many states have chosen not to adopt USP standards. I am not asking for that, but there must be a way to have some flexibility or exceptions that allow us to take care of our patients and maintain access to affordable compounds.  

Thank you for your time.