Statement of Ronna B. Hauser, Pharm.D. Vice President, Pharmacy Affairs National Community Pharmacists Association

Transcription

1 Statement of Ronna B. Hauser, Pharm.D. Vice President, Pharmacy Affairs National Community Pharmacists Association Food and Drug Administration [Docket No. FDA 2017 N 1847] Pharmacy Compounding Advisory Committee Meeting May 8, 2017 Slide 1 Good afternoon and thank you for allowing me this opportunity to share community pharmacy s perspective regarding discrepancies that we have noticed related to FDA inspections of manufacturers and compounding pharmacies. I am Ronna Hauser, Vice President of Pharmacy Affairs at the National Community Pharmacists Association (NCPA). NCPA represents America s community pharmacists, including the owners of more than 22,000 independent community pharmacies. According to a member survey, approximately 88 percent of our members provide some type of compounding service, but over 95% of respondents stated they do not plan to register as a 503B outsourcing facility. Therefore, the vast majority of our members will be held to the laws and regulations of section 503A of the Food, Drug, and Cosmetic Act.

2 When inspected by the FDA, our members potentially receive an FDA Form 483. This form is issued at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts. It is important to note that the compounding inspections that have been conducted to date by the FDA are focused on community based compounding pharmacies. As discussed earlier this morning, FDA has inspected only 1 physician compounder and no federal facilities, to our knowledge. We are also unsure how many compounding pharmacies residing in health systems have been conducted but believe this number to be very small or none at all. NCPA feels strongly about the quality of compounded medications and after learning of several of our members experiences with FDA inspections and subsequent public posting of Form 483 s we sought information on how the inspections were similar to those of FDA registered manufacturers. 2

3 I will discuss what information we were able to find. I will also discuss how similar the observations being documented at FDA registered facilities are to those that FDA publicly reports as unsafe in a compounding environment. Slide 2 When a Form 483 is presented to a compounding pharmacy, it is also posted by the FDA to the FDA website. See slide 2 for all postings and slide 3 is an individual Form 483. I also wanted to point out that there have been multiple observations on publicly posted 483 s related to veterinary compounding, even though veterinary compounding is not under the purview of the Drug Quality and Security Act. Conversely, when perusing the FDA website to search for any Form 483 s given to FDA registered manufacturers, all that can be found are inspection citations and inspectional observation summaries. I have been unable to find any Form 483 for a FDA registered manufacturer facility posted to the FDA website. 3

4 The manufacturer inspection citations are on an excel spreadsheet and list a brief description of the general nature of the violation. The inspectional observation summaries summarize the number of 483s in various fields and you can expand a specific field to see the frequency of the violation. See slide 4 where you can download FDA inspection citation spreadsheets and slide 5 which is a snapshot of the FY 2016 spreadsheet. It is our understanding that software utilizing consistent language is able to summarize in spreadsheet format observations for FDA registered manufacturers. The manufacturers found on these spreadsheets are well known. Slide 6 is a snapshot of the observation summaries. As you can see, the information posted to the website pertaining to inspections of compounding pharmacies are much more detailed and in depth than those posted for FDA registered manufacturers. 4

5 As you can also see, many of the same observations found in compounding pharmacies are the exact same ones found in FDA registered manufacturing facilities. See slide 7 which are citations pulled directly from the FY 2016 inspection citations spreadsheet. However, FDA presents the findings of inspections of compounding pharmacies in a much more intense manner than those of registered manufacturers. This is evidenced by discussions at Pharmacy Compounding Advisory Committee (PCAC) meetings and reports to Congress for example. While FDA publicizes Form 483s and photographs from compounding pharmacy inspections, we have evidence of several of the same observations from cgmp manufacturers, with no corresponding publicity. It seems like there is intent to sway the public to be afraid of compounding. The observations from inspections of compounding pharmacies have been over generalized as applying to the entire profession. This has led some to believe the majority of compounding is done in substandard conditions, when in reality this is not the case. These overgeneralizations are detrimental to pharmacies and patients. 5

6 I would like to show you pictures of compounding labs and encourage you to visit a compounding pharmacy. See slide 8 which includes pictures of non-sterile, non-hazardous drug compounding labs. If you have not visited a compounding pharmacy, I am happy to personally set up a visit for you. In summary, violations do occur in even the most advanced manufacturing processes. Unfortunately the public is unable to see more details of violations found in FDA registered facilities as manufacturer 483 s are not public information to my knowledge. At the same time, 483 s from compounding facilities are publicized. I appreciate the opportunity today to point out these discrepancies and I want to make clear that in whatever environment deficiencies are cited they should immediately be addressed. However, we must always keep all findings in context. NCPA is committed to working with the FDA, the Committee and other stakeholders regarding these important matters. We appreciate your consideration of our remarks today. Thank you. 6