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ForumsCompounding & FormulationCompounding pharmacy clean room standards — my results so far Page 2

Compounding pharmacy clean room standards — my results so far

SaraMom3 Thu, May 2, 2024 at 7:47 PM 12 replies 2,138 viewsPage 2 of 3
Dr.LipidDallas
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Dec 2023
Dallas, TX
May 2, 2024 at 10:12 PM#6
I called them. The customer service rep had no idea what I was talking about. I asked for the Pharmacist-in-Charge. They said he was "unavailable" and would call me back. Meanwhile I checked the FDA's drug recall database and found that they had a voluntary recall 10 months ago for one batch of a different compound (not semaglutide) due to "potential lack of sterility assurance." I think I'm switching pharmacies.
10 13pam_stl, wei_SG, cory_ATX and 7 others
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Dr.MetabolicMD
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Jan 2024
Rochester, MN
May 2, 2024 at 11:08 PM#7
Trust your gut on this one. The combination of: - FDA Warning Letter for insanitary conditions - Customer service unaware of the Warning Letter (suggests poor internal communication or culture of transparency) - PIC "unavailable" when asked about regulatory issues - Voluntary recall for sterility concerns ...paints a picture of a facility with systemic quality problems. Any ONE of these would be a yellow flag. Together, they're a parade of red flags. When you switch, use this thread's guidance to vet your new pharmacy BEFORE you order. Here's my quick screening protocol: 1. Confirm 503B registration on FDA's list 2. Search FDA Warning Letters database for the company name 3. Search state board of pharmacy for any disciplinary actions 4. Search FDA Drug Recalls for any products from that company 5. Call and ask the quality questions from the USP <797> thread 6. Request a Certificate of Analysis for your specific product Takes about 30 minutes. Worth every second.
11 14PedsEndoPhilly, SleepDoc_PDX, RegAffairsDC and 8 others
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Dr.BariatricHTX
Senior Member
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Feb 2024
Houston, TX
May 3, 2024 at 12:04 AM#8
One more resource I should have mentioned: the FDA's Compounding Quality Center of Excellence has been publishing inspection summaries and data on outsourcing facilities. They're increasing transparency around compounding quality. Also, the Pharmacy Compounding Accreditation Board (PCAB) — if a pharmacy has PCAB accreditation, they've undergone a voluntary third-party quality assessment. It's not a guarantee of perfection, but it's an additional layer of vetting. More on that in other threads. Stay vigilant, everyone. The compounding industry is largely self-policing between FDA inspections. Educated consumers are the best watchdogs.
12 15Dr.EM_Chicago, pete_RVA, CarlaRPh_TPA and 9 others
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Dr.LipidDallas
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Dec 2023
Dallas, TX
May 3, 2024 at 1:00 AM#9
UPDATE: I found a new pharmacy that's 503B registered, has NO Warning Letters, NO recalls, and has PCAB accreditation. They were able to answer all the USP <797> questions without hesitation and emailed me a CoA before I even placed my order. The cost is about $40/month more than my old pharmacy. Worth every penny for peace of mind. I also filed a complaint with the Mississippi Board of Pharmacy about my old pharmacy's customer service response (or lack thereof) when I asked about their FDA Warning Letter. Thanks to everyone in this thread. This forum may have saved me from a serious health issue.
13 16lori_vegas, Dr.PulmRoch, maya_sedona and 10 others
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