- Enclara Pharmacia Inc.
April 11, 2017
US Customs House, Room 900
200 Chestnut Street
Philadelphia, PA 19106
RE: Response to FDA Warning Letter 17-PHl-09
Dear Mr. Cherry:
I am writing in response to the U.S. Food and Drug Administration (FDA) Warning Letter referenced above issued to Enclara Pharmacia with respect to its mail order pharmacy located in Sharon Hill, PA (pharmacy). The letter directed Enclara Pharmacia to notify the FDA in writing of the steps the company planned to take to correct the alleged "deficiencies" outlined in therein. We respectfully request the FDA to post this response letter on its website and provide a copy of this letter anytime the FDA provides a copy of its Warning Letter to anyone outside the FDA.
Please be aware that for business reasons unrelated to the allegations contained in the initial FDA Form 483 or the Warning Letter, Enclara Pharmacia ceased performing sterile compounding at this pharmacy effective January 1, 2017. The enclosed copy of the most recent inspection by the Pennsylvania Board of Pharmacy confirms we are not engaged in sterile compounding at the pharmacy.
As an initial matter, given we are no longer dispensing sterile compound medications from the pharmacy, we respectfully request the FDA dismiss Warning Letter 17-PHl-09.
As alluded to above, we elected to cease the practice of sterile compounding for business reasons. Substantively, and as explained in further detail below, we continue to disagree with the allegations contained in the Warning Letter since we firmly believe our operations complied with applicable law at all times, as evidenced by the most recent National Association of Boards of Pharmacy (NABP) inspection of the sterile compounding at the pharmacy. Please note that such NABP inspection included a review of the same practices reviewed by the FDA during its onsite inspection in June 2016.
Enclara Pharmacia's sterile compounding at the pharmacy met all applicable regulatory standards for a compounding pharmacy, specifically, United States Pharmacopeia 797 (USP 797). The pharmacy is licensed by the Pennsylvania Board of Pharmacy (license number PP481494) as a pharmacy and prior to January 1, 2017, we performed a small amount of low-risk patient-specific compounding which constituted less than 1 percent of our prescription volume. The pharmacy's compliance with applicable law and USP 797 was confirmed independently through an inspection by the NABP in February 2016. We understand the FDA received a copy of this inspection report. NABP did not identify any issues with compliance with Current Good Manufacturing Practices (CGMP) because federal law does not require a state-licensed pharmacy performing patient-specific compounding to meet Current Good Manufacturing Practices (CGMP). See 21 U.S.C. § 353a(a).
In contrast, the observations contained in the FDA Form 483 and Warning Letter alleged that our pharmacy was deficient in a number of areas of practice related to our pharmacy's failure to comply with CGMP. In our view, every one of these observations incorrectly measured Enclara Pharmacia's operations against CGMP, which, as noted above, do not apply to compounding pharmacies.
The Warning Letter specifically directed us to review the agency's guidance on pharmacy compounding posted on the FDA's website. The website references Section 503A of the FDCA (Food, Drug and Cosmetic Act), which states:
Sections 351(a)(2)(B) [Current Good Manufacturing Practices] ... of this title shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order ... if the drug product meets the requirements of this section, and if the compounding- (1) is by- (A) a licensed pharmacist in a State licensed pharmacy or a Federal facility .... 21 U.S.C. § 353a(a).
The observations in the Form 483 and the alleged deficiencies in the Warning Letter are based solely upon CGMP standards which do not apply to sterile compounding in state-licensed pharmacies. Such compounding is subject to the provisions outlined in United States Pharmacopeia (USP) 797. The NABP inspection referenced above measured Enclara Pharmacia against USP 797 and found we met those requirements.
Further, the Warning Letter specifically incorrectly highlighted our use of non-sterile lint-free wipes and non-sterile disinfectants creating the risk of contamination. Please be aware that neither of these products was used to sterilize surfaces or equipment prior to performing sterile compounding. Instead, all surfaces and equipment were treated with sterile 70 percent isopropyl alcohol solution and allowed to dry before a compounder began to perform sterile compounding. Accordingly, we believe the observations in the Form 483 and Warning Letter were mistaken. In furtherance of our position, the NABP inspector observed the compounding of a sterile IV product in February 2016 and identified no concerns with our cleaning procedures.
We appreciate the opportunity to respond to the FDA's Warning Letter. For the reasons discussed above, we respectfully request the FDA dismiss Warning Letter 17-PHl-09. Should the agency decide not to dismiss the Warning Letter, we respectfully request the FDA post this response letter on its website and provide a copy of this letter anytime the FDA provides a copy of its Warning Letter to anyone outside the FDA. For these reasons, and because we are no longer performing sterile compounding at this location, we ask that this matter be closed out.
Please contact me if you have any further questions.
John R. Loxterman
VP, Chief Compliance Officer