Feedback for Seeking Feedback on Non-Sterile Compounding Standards  ·  Nov. 17, 2016

We welcome the opportunity to provide feedback on the draft guidelines for Non-Sterile Compounding. There are a few items we wish to submit feedback on:

Pg 11-12 (Box inset) – The definition of “Complex” preparations needs clarification. Examples provided include, “transdermal dosage forms, modified-release preparations, and some inserts and suppositories”. The basis on which these are being categorized is not clear.

For example, what is it about “suppositories for systemic effects” that make it a “complex preparation? In this instance, Level B requirements would be needed to compound. We would argue that Level A requirements would be sufficient for many formulas deemed “complex” on the basis of the examples provided.

Further, the guidelines suggest factors such as more complex calculations, procedures, or lack of stability data would change its category and thus elevate the level requirements needed for compounding. However, such factors have little if any bearing on the facility and safety requirements that the preparation ought to be compounded under. Rather, and most importantly, it is the active ingredient being used, its risk as a hazard, and the quantity of which being handled that are the dependant factors that should determine the level requirements.

As a result, there are concerns with attempting to align preparation categories (simple, moderate, complex) to level requirements that describe facility and safety requirements.

  • We propose that a change be made to include professional judgment in deciding whether complex preparations can be suitably compounded within Level A requirements.
  • We propose that pharmacists consider the active ingredient and quantity being handled to determine what level requirements are needed.

Pg 25 - We have concerns with the phrasing of the last sentence which reads, “The development of a new master formulation must be based on scientific data…” This phrasing does not allow the pharmacist to develop a new formulation using their knowledge, experience, expertise and training. This is the very essence of compounding. Further, such phrasing will likely limit the ability of the pharmacist to work with practitioners (Human or veterinary) in providing patients with alternative treatment options where commercial options have failed. - We propose that the wording be modified to include “When Available”

Pg 27 (last paragraph) - Clarification is required in defining “ingredients” and “drug”. Drug products can be withdrawn from the market for a specific strength however alternative strengths remain available. Further, drugs can be withdrawn for human use but still used regularly in veterinary practice (e.g. Cisapride). Lastly, if a drug is withdrawn for systemic use would this limit its use specifically in a topical form that would not act systemically? - We propose that the guideline clarifies complete withdrawal of an active ingredient from the market. - We also recommend that consideration be made for veterinary compounding to clarify situations where drugs are removed for human use explicitly.

Pg 38 - With respect to ventilation to the outside for Level C requirements, there are challenges in some pharmacies with venting to the outside. - We propose that the guidelines allow for alternative venting (e.g. ventilating to a trap) where ventilation to the outside is not possible. Alternatives could be developed in consultation with experts in the field.

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