Bond Pharmacy, Inc. dba Advanced Infusion Solutions - 497408 - 08/10/2017
- Bond Pharmacy, Inc. dba Advanced Infusion Solutions
AIS Leading the Way
in Intrathecal PainCare
August 10, 2017
VIA EXPRESS MAIL
Monica R. Maxwell
Acting Program Division Director
U.S. Food & Drug Administration
Office of Pharmaceutical Quality Operations,
4040 N. Central Expressway, Suite 300
Dallas, TX 75204
Re: Bond Pharmacy, Inc. d/b/a Advanced Infusion Solutions
("AIS") Warning Letter (Ref# 2017-NOL-06)
Dear Ms. Maxwell:
I write in response to your letter dated July 14, 2017, wherein you identified additional information that you needed to evaluate AIS's proposed corrective actions in its response to the U.S. Food & Drug Administration's ("FDA") March 1, 2017 Warning Letter ("A/S's FDA Response"). I understand FDA's interest in ensuring that AIS, like all other Section 503A compounding pharmacies, provides its patients with safe compounded medication. I wish to assure FDA that AIS has this same interest, and that it will take any and all steps necessary to cooperate with FDA as it continues its review. To that end, I hope the following additional information assists you in evaluating AIS's corrective actions.
First, AIS appreciates the need to prevent any alleged or potential contamination of its stock solutions through exposure to lower than ISO class 5 quality air. As stated in AIS's FDA Response, "AIS reevaluated its procedures related to stock solutions" and, among the steps mentioned, "elected to treat all stock solution containers as a single dose vial" and to access each vial using a "needle-free access device." AIS believes its use of the needle-free access device will prevent contamination of its stock solutions because its use is an integral part of AIS's overall revised procedure for accessing stock solutions.
AIS's revised procedure takes place entirely in an ISO class 5 environment, using only sterile equipment. First, the stock solution bag is cleaned and disinfected using appropriate aseptic technique and placed in an ISO class 5 environment. Once inside the ISO class 5 environment, the stock solution is accessed using the sterile, needle-free access device. The accessed stock solution remains in the ISO class 5 environment at all times. In preparing patient-specific compounded sterile products, withdrawal of the contents of the stock solution is done aseptically using only sterile syringes. AIS's policy, moreover, is to discard the stock solution container after six hours of use regardless of whether all of the contents of the stock solution have been used. A photographic representation of AIS's procedure is attached hereto, along with a data sheet on the device, photographs of the device packaging reflecting proof of sterility, and a brochure explaining the device's use in preparing sterile preparations. See Group Exhibit A. In sum, although it is true that the needle-free access device was first developed for catheters, the same technology is now available for compounders and is a vital component of AIS 's overall procedure to ensure that its stock solutions remain free of any potential contamination.
Second, with respect to AIS's stated use of sterile wipes, the supporting documentation you requested is attached hereto. The documentation includes Certificates of Conformance, Analysis and Sterility for the sterile wipes, see Exhibit B, and 70% sterile IPA, see Exhibit C, that AIS has purchased from Contee® over the last seven months. In addition, I have attached invoices for the sterile wipes and 70% sterile IPA dating back to June 2016, see Exhibit D, and a photograph of the sterile wipes AIS uses from Contee®, see Exhibit E. AIS has, moreover, updated its policy, PHA-412- RDG-Conduct of Personnel in Controlled Areas and Aseptic Technique Overview, to reflect the following:
8.2: All work areas are to be cleaned and disinfected according to PHA-304. Specifically only sterile wipes will be used in an ISO Class 5
This supporting documentation and policy revisions affirm AIS's statement made in its FDA Response that it "now only uses sterile wipes in the ISO 5 environment."
Please do not hesitate to reach out to me should you have any additional questions or concerns.
Very truly yours,
Charles (Chuck) R. Bell, Jr., PharmD, RPh