RESPONSE TO FDA WARNING LETTER
Regarding the “Warning Letter” received by Talon Compounding Pharmacy on October 5, 2017
Thanks for looking up information about this and for taking time to read our response.
This Warning Letter is a restatement of observations the inspectors made when they visited us in June of 2016. All of the items listed as “observations” were addressed in July of 2016. We are angered by the fact that the re-release of this information may cause our patients and colleagues to believe that any deficiencies have continued from 2016 until now. They have not. All deficiencies were corrected in the weeks following the 2016 inspection.
We are busy continuing to make quality compounded products AND writing a detailed response to each point in this Warning Letter. Check back in the coming days for a full explanation and rebuttal to accusations made against our pharmacy.
As co-owners, we each work full time at our pharmacy and strive to provide quality compounded products in a time when the FDA, which has no powers of enforcement, instead uses the tactic of Warning Letters to bully compounding pharmacies.
Finally, we want our customers to know that we are grateful for regulations which ensure the safety of compounded medications. We feel that the 2016 inspection made us an even better pharmacy at a time when we were transitioning into ownership of Talon.
Information from International Association of Compounding Pharmacies (IACP)
Since passage of the Drug Quality and Security Act (DQSA) in 2013, the FDA has implemented and enforced the law in a way that is inconsistent with its congressional intent as has been expressed to the agency multiple times in the form of statements in the congressional record, letters from Congress, questions for the record asked in congressional hearings, directives in the reports accompanying FDA’s appropriations bills, stakeholder input, and in some cases, the plain language of the statute.
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*No compounded medication is reviewed by the FDA for safety/efficacy.