Feedback for Seeking Feedback on Non-Sterile Compounding Standards

Pharmacist  ·  Nov. 15, 2016

If I understood well we are going from the guidelines that already exist to standards for pharmacy compounding in 2019? No matter what I found the model of standards for pharmacy compounding for non-sterile preparations very thorough but as number one mentioned it’s similar to USP standards. I believe the appendices are informative and helpful. We can use them instead of trying to create our own. I have some issues: 1.Dedicating a whole room for compounding level C might create problems space wise and time wise for changes, besides costs for the compounding pharmacies. It might not be feasible for some pharmacies but the standard for referral to another pharmacy for compounding is very beneficial for continuation of service to our patients 2.As mentioned on page 24 “ extensive experience in non-sterile compounding and broad scientific knowledge are required to determine a BUD and to interpret stability data in relation to the actual compounded formulations “ I personally think it would have been very helpful if we had access to another appendix with the most common compounding mixture and their BUD, if possible. 3.I would have appreciated another 2 appendices : 1. One with the list of the different groups of the NIOSH (Group 1, Group and Group 3) I looked under NIOSH and I did not really
find a comprehensive list. Also a clarifications: group 2 and 3 are mentioned in both level A and level B requirements. 2. An appendix of Master Formulation at least one with the most common compounding mixtures used and the ones for which stability data are not available. This would save time, guarantee a quality product and uniformity between pharmacies. So the patient would get the same product from different pharmacies. As no 3 mentioned `The finished product should have scientific papers to support both the chemical and physical stability of the product ``I find it difficult to find all the scientific evidence for each product, even the ones found might not be complete or up to date thus I believe we need some help with lists, appendices, specific references( not general like appendix 7).Availability of training specific to all the requirements of these standards would be a good idea too.. We are not a compounding pharmacy but I would be the first to participate in training because I think it’s very important for extensive experience and scientific knowledge that is required ( as per page 24) It is a huge change but I believe it would give the opportunity to more pharmacies to specialize in compounding since it would restrict the general pharmacies involvement due to extra requirements. But safety of the patients and staff is our priority.

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