John W. Hollis, Inc DBA John Hollis Pharmacy - Company
JOHN W. HOLLIS, D.Ph.
110 20th Avenue n.
Nashville, TN 37203
Ph (615) 327-3234 / Fax (615) 320-0680
September 18, 2014
Ruth P. Dixon, Acting District Director
Food & Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
RE: WARNING LETTER NO. 2014-NOL-20, DATED SEPTEMBER 4, 2014 TO JOHN W. HOLLIS, INC DBA JOHN HOLLIS PHARMACY
Dear Ms. Dixon,
Hollis Pharmacy is committed to complying with applicable laws and regulations, and to ensuring high-quality care for its patients and has done so for the past 25 years. As a retail, compounding pharmacy that is licensed and regulated by the State of Tennessee, we believe we should not be held to the standards and regulations applicable to FDA- regulated pharmaceutical manufacturers. The issues and concerns by the FDA in the Warning Letter issued September 4, 2014, have been addressed and were reported to the FDA in March and May 2014. Receiving the Warning Letter seems a redundant recitation of issues that have already been resolved. Nevertheless, this letter responds to the FDA's concerns and, where appropriate, identifies areas where we have made (as already mentioned) voluntary changes to address these concerns.
A.Compounded Drugs under the FDCA - We disagree with the FDA’s opinion that Hollis Pharmacy was not entitled to the exemptions in Section 503A of the FDCA. We had received a limited number of “office use” prescriptions at the time of the FDA’s five days of inspection in Feb/March, 2014. However, we believe we were in compliance with our Tennessee State Pharmacy Board regulations that allowed for “office use” compounding at that time. Nevertheless, we have taken corrective actions. On March 3, 2014, we changed our policy and procedures and have, since that date, filled and compounded only valid prescriptions for specific individually identified patients for all prescriptions (sterile and non-sterile). The investigators were made aware of this change of policy during the inspection. Copies of that policy and procedure are available upon request. Additionally, we no longer fill and compound prescriptions for sterile medications at all and notified the FDA of this action on May 14, 2014, which is acknowledged in the Warning Letter.
B.Violations of the FDCA – The management of Hollis Pharmacy undertook a comprehensive assessment of our operations, including facility design, procedures, personnel, processes, materials, and systems, and determined to cease all aseptic sterile compounding operations. This decision was due to several reasons including, but not limited to, the costs and regulatory burdens associated with becoming either USP 797 compliant, or an Outsourcing Facility, or CGMP compliant. The FDA was notified of this action on May 14, 2014. Therefore, these cited and now past violations re: Adulterated Drug Products are moot and have been since that date. As for the cited past violations re: Unapproved New Drug Products and Misbranded Drug Products, Hollis Pharmacy since March 3, 2014, no longer fills prescriptions for “office use” but rather only for specific individually identified patients for all of the prescriptions that we compound (which are now only non-sterile), and therefore, are no longer in violation of Sections 505(a) and 301(a)(d)(k) and 502(f)(1) of the FDCA.
Hollis Pharmacy will review your recommendations if management should ever decide to resume filling specific individually identified patient prescriptions for sterile medications, which, however, is not in the foreseeable future. It is unfair for the FDA to have publicly singled out Hollis Pharmacy over the issue of filling and compounding “office use” prescriptions in the past while other similar pharmacies did the same and to the best of our knowledge were undisturbed by the FDA.
We respectfully request that the FDA post our response on the appropriate website.