Inspections, Compliance, Enforcement, and Criminal Investigations

Green Hills Health and Wellness Pharmacy Inc - Company Response Letter 6/25/15

June 25, 2015

Rebecca Asente, Compliance Officer
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200, Ste 500
Nashville, TN 37217
  Via Federal Express


Re: Response to Warning Letter No. 2015-NOL-10

Dear Compliance Officer Asente,

This letter is in response to the above-referenced Warning Letter which we received on June 5, 2015. We respectfully request that this response, excluding the attachments, be posted on the FDA’s website with the Warning Letter and be included every time the FDA provides a copy of the Warning Letter issued to Health & Wellness to anyone outside the FDA. The bulk of the alleged violations set forth in the Warning Letter relate to our prior failure to have a patient-specific prescription for every drug dispensed by our pharmacy. Specifically, (b)(4) prescriptions examined and dispensed from 07/14/2014 through 10/14/2014 were for in-office use and were not issued for specific patients. All (b)(4) physician-ordered non-sterile compounded products were provided to dermatology offices in Tennessee for in-office use, as allowed by Tennessee state law. As stated in our letter dated November 11, 2014 responding to the Form 483 issued at the conclusion of the FDA’s inspection, we have ceased dispensing any medication without a patient-specific prescription. Therefore, since October 22, 2014, all compounded drugs dispensed by our pharmacy have been in compliance with Section 503A of the Federal Food, Drug, and Cosmetic Act (“FDCA”), and are entitled to the FDCA exemptions for new drug approval, compliance with current good manufacturing practices (“CGMPs”) and labeling granted to such drugs.

In response to the allegation in the Warning Letter that drugs prepared by the pharmacy may be in violation of Section 501(a)(2)(A) of the FDCA and the recommendations in the Warning Letter that the pharmacy undergo a comprehensive assessment of its operations and seek third party consultant review, we would like to make you aware that our pharmacy worked with a consultant and sought and received full accreditation for both Sterile and Non-Sterile Compounding effective January 26, 2015, from the Pharmacy Compounding Accreditation Board (PCAB), administered by the Accreditation Commission for Health Care (ACHC). Accreditation with ACHC/PCAB requires past and future compliance with USP Standards, and Continuous Quality Improvement in our procedures. Additionally we are subject to spontaneous PCAB inspections to ensure our compliance with applicable USP Standards. In contrast to the CGMP requirements referenced in the Warning Letter (which are applicable to drug manufacturers and are not applicable to compounding pharmacies operating in accordance with Section 503A), PCAB accreditation relies on standards established by USP Chapter <797> for sterile compounding and USP Chapter <795> for non-sterile compounding.

Quality processes regarding staff training, gowning, cleaning, environmental monitoring, and material and personnel flow within the cleanroom complex are essential to ensure sanitary conditions and preparation of unadulterated products. Quality processes should result in quality results. As required by USP Chapter <797> for Sterile Products, we have compounded products tested by an independent laboratory with results which demonstrate that good aseptic processes are in place at our pharmacy. Additionally, although the pharmacy is not required to comply with the CGMPs detailed in the Warning Letter, we have written Standard Operating Procedures (SOPs) for each of the following topics in accordance with USP Chapter <797> requirements:

Preparation and compounding of sterile drug products, including validation of sterilization processes. (See Attachment 1)

Cleaning and disinfecting the room and the equipment to compound sterile products. (See Attachment 2)

Monitoring of environmental conditions in the sterile processing area. (See Attachment 3)

Testing of sterility and pyrogen content using an outside laboratory in conformance with USP Chapter <797> Guidelines. (See Attachment 4)

When extended BUD testing is needed, a written testing program that addresses the stability, sterility, and endotoxin levels of compounded drug products up to, but not exceeding, 180 days. (See Attachment 5)

The Warning Letter also states that our November 11, 2014 letter responding to the issues identified in the FDA 483 was inadequate since it was not clear (1) whether the sterile sporicidal pre-soaked towels used to clean the ISO 5 area would be a non-particle shedding/lint-free material, and (2) whether the pharmacy would continue to use self-sterilizing disinfectant outside the ISO 5 area. The sterile sporicidal wipe used to clean the ISO 5 area is a non-particle shedding/lintfree material, as necessary to meet the requirements of USP Chapter <797>. We have begun using a sterile cleaning solution outside the ISO 5 Areas, for best practices, and are amending our SOP's accordingly. (See Attachment 6 for Sterile Cleaning Product and Attachment 7 for sporicidal non-particle shedding/lint-free material for ISO 5 areas.)

In conclusion, this pharmacy is respectful of the suggestions and comments made during the FDA’s inspection in October 2014, and in the recent Warning Letter, and we realize that the FDA has a duty to the public to prevent public harm. I realize that it is my responsibility to ensure sterile and non-sterile products are prepared under quality processes and in compliance with the high standards imposed on our compounding pharmacy practice.


Sincerely,

/S/

Dr Mark F Binkley, DPh
President / CEO

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