Feedback for Seeking Feedback on Non-Sterile Compounding Standards

Pharmacist  ·  Nov. 12, 2016

Respectfully, there are some concerns with these comments.

1) It would be inappropriate to remove "CF (Canadian Formulary)" as it is officially included in the Food and Drugs Act (Canada) in Schedule B along with other recognized international pharmacopeia in terms of a recognized reference source. It should therefore be retained.

2) The "page 11" reference to suggesting removal of the Captopril Oral Solution is not necessary. This is an official formulation which has a USP monograph (see: 2015 USP Compounding Compendium, p424), where the pH range is part of the monograph and so to meet the requirements of the official reference source, pH must be established as per the monograph. The fact that "some formulations do not pH adjust" doesn't change the requirement to do so per official reference sources.

3) Re page 27 and the suggestion to define "purified water," there is no reason to do so, since Purified Water USP has an official USP monograph and therefore a standard is set that "defines" this, as is the case for any/all species that have a USP monograph. (See 2015 USP Compounding Compendium, where it is also "defined" at page 35 under "Compounding Facilities").

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