- Home Intensive Care Pharmacy LLC
HOME INTENSIVE CARE PHARMACY
7220 Louis Pasteur
San Antonio, TX 78229
February 9, 2014
Ms. Rose Ashley
FDA Dallas District Office
U.S. Food and Drug Administration
4040 North Central Expressway
Dallas TX 75204-3158
Re: Response to Warning Letter (Home Intensive Care Pharmacy, LLC) Dated January 22, 2014; Ref. 2014-DAL-WL-02
Dear Ms. Ashley:
We are in receipt of the Warning Letter dated January 22, 2014. Home Intensive Care Pharmacy, LLC (HIC") is a third generation pharmacist owned, compounding pharmacy and a small business located in San Antonio, Texas. My father opened his first pharmacy in 1969. He grew up in a family of pharmacists but had always dreamed of opening his own pharmacy. Over the past four-plus decades, we have witnessed first hand many changes and challenges in the practice of pharmacy compounding; we strive to keep involved, informed and compliant concerning regulatory and other issues that arise in the industry. I currently serve as Third Vice President of the National Community Pharmacist Association where I hope to eventually become one of a short list of second generation presidents of this robust organization. I have also been very involved with the International Academy of Compounding Pharmacists for a number of years and was awarded one of the most prestigious honors a compounding pharmacist can receive - the PCCA Compounding Pharmacist of the Year in 2010. When the Senate HELP Committee began discussions on drafting a bill to address the lack of regulation and uncertainty surrounding the practice of pharmacy compounding, I was personally invited to work with them in helping to draft the first piece of legislation. In short, I am well versed and educated with respect to common (and best) practices for pharmacy compounding prior to and since the passage of the Compounding Quality Act, Pub. L. No. 113-54 on November 27, 2013. In light of this background, we submit the following:
Response to Warning Letter Dated January 22, 2014
FDA's Warning Letter makes three broad assertions: FDA alleges that Home Intensive Care's compounded drug products are (1) misbranded, (2) adulterated, and (3) compounded in violation of various current good manufacturing practices ("cGMP") set forth in 21 C.F.R. Part 211 . FDA also stated in its Warning Letter that certain statutory exceptions to Section 503A of the Federal Food, Drug, and Cosmetic Act ("FDCA") did not apply to HIC's drug products compounded for office use at the time of the inspection (February-March of 2013) because the pharmacy is located in the Fifth Circuit, where FDA claims it allegedly was permitted to apply FDCA Section 503A. Warning Letter at 2 n.1.
Home Intensive Care Pharmacy respectfully asserts that FDA's allegations are factually and legally unjustified. FDA's statement that Section 503A applied to HIC when it inspected the pharmacy back in March 2013 is inconsistent with FDA Commissioner Dr. Margaret Hamburg's Congressional testimony concerning FDA's enforcement authority against compounders on April 16, 2013 -just a month after the inspection of HIC.1 During that Congressional hearing, Dr. Hamburg testified that FDA's enforcement authority over compounding pharmacies was "unclear," "ambiguous," "and the law is not well suited to effectively regulate this evolving industry." Dr. Hamburg Testimony at 6. FDA's current position with respect to HIC also conflicts with FDA's prior public statements about the degree of its enforcement authority over compounding pharmacies and the enforceability of FDCA Section 503A prior to its clarification upon passage of the Compounding Quality Act in November 2013. In addition, FDA's own Compliance Policy Guide confirms that FDA believed at least as far back as 2002 that "presently section 503A in its entirety is invalid.'' FDA, Compliance Policy Guide for FDA Staff and Industry, § 460.200 (Pharmacy Compounding) (2002) (emphasis added) (withdrawn December 4, 2013 upon FDA's circulation of draft guidance concerning implementation of Section 503A upon passage of the Compounding Quality Act. (78 Fed. Reg. 72841 (Dec. 4, 2013)).
Furthermore, given that state boards of pharmacy have traditionally regulated compounding pharmacies, HIC has always engaged in significant measures to ensure that any office use compounding that it performed complied with state law; its actions were and are consistent with the Texas State Board of Pharmacy regulations currently in effect, and in effect during the relevant time.2
It is inexplicable that FDA would specifically use the terms "unclear" and "ambiguous" to describe its enforcement authority a month after its inspection of HIC, and now assert that HIC violated the misbranding, adulteration and cGMP provisions of the FDCA because it engaged in office use compounding under that same authority. As stated in response to FDA's Form 483 Inspection Observations (Letter dated April 11, 2013), HIC has acted in compliance with state laws (permitting office use compounding),3 and its compounding practices are consistent with United States Pharmacopeia guidelines. Furthermore, to the extent that HIC's compounding practices were allegedly violative of certain provisions of the FDCA as set forth in FDA's Form 483 Observations, the pharmacy addressed those alleged violations in its responses thereto. Those responses, dated April 11, 2013, July 19, 2013, and September 30, 2013, are attached hereto.
Future Compounding at Home Intensive Care Pharmacy; Elimination of Office Use Compounding Until Further Notice or Clarification of the Federal Law
Notwithstanding FDCA Section 503A's prior ambiguity and questionable enforceability per FDA's own various admissions, HIC intends to comply with the newly enacted Compounding Quality Act (including the Act's reaffirmation of Section 503A). HIC will not be registering as an Outsourcing Facility under Section 503B of the Act, and thus will not be engaged in Outsourcing Facility activities, such as sterile compounding for office use, that are otherwise permissible by Outsourcing Facilities under certain conditions set forth in that section of the new Act.
Instead, HIC is refocusing its operations and business model to engage in compounding for individually identified patients pursuant to a valid prescription or order in accordance with Section 503A, regardless of Texas's state law permitting office use compounding. Thus, in compliance with the Compounding Quality Act and FDCA Section 503A, HIC will no longer be preparing non-patient specific compounded medications for hospitals, emergency responders (EMS, etc.), or any other entity. HIC will compound drug products pursuant to prescriptions or orders written for individually identified patients. HIC believes there is still substantial controversy surrounding traditional office use compounding, which has been performed by pharmacists since the creation of the Apothecary. Based on the new federal law creating Outsourcing Facilities (Section 503B) as well as revitalized Section 503A, however, HIC is committed to compliance by ceasing all non-patient specific compounding.
In all its years of operation, HIC has never been cited by the Texas State Board of Pharmacy for inappropriate office use compounding, misbranding, or compounding adulterated drugs; nor has it been deemed a drug manufacturer based on its compounding of drugs for office use, which activity is permitted under state law. The FDA's assertions in the Warning Letter are based not on testing of HIC's compounded products, but instead on the fact that HIC's products, which were compounded for office use (and which were limited in number), did not comply with federal cGMP requirements for drug manufacturers. HIC is not a drug manufacturer. During the February-March 2013 inspection, FDA did not cite any contamination of compounded drug product or identify product that should be recalled because of a lack of assurance of sterility. HIC respectfully asserts that it engaged in corrective actions concerning FDA's findings in the Form 483 Observations issued.
Home Intensive Care Pharmacy is excited about moving forward and cautiously optimistic that FDA's mission and enforcement activities will continue to evolve in a way that allows the traditional art and science of compounding to continue impacting patient outcomes in a positive manner. In the meantime, as stated above, HIC will engage in compounding activities in accordance with newly revived Section 503A, including, but not limited to, compounding for individually identified patients pursuant to a valid prescription or order. We respectfully request that HIC's responses to the Form 483, along with HIC's response to this Warning Letter response be posted (along with the already posted FDA Form 483 and Warning Letter) on the FDA's enforcement activities website.
Please do not hesitate to contact me if you have any questions concerning the foregoing.
John Jeff Carson, R.Ph.
Home Intensive Care Pharmacy
Enclosures (Responses to FDA Form 483 Observations)
1 A Continuing Investigation into the Fungal Meningitis Outbreak and Whether it Could Have Been Prevented: Hearing Before the Subcomm. on Oversight and Investigations of the H. Comm. On Energy and Commerce, 113th Cong. (Testimony of Margaret A. Hamburg, M.D., Commissioner, FDA) (Apr. 16, 2013) ("Hamburg Testimony").
2 HIC has been inspected by the Texas Board of Pharmacy- as recently as February 25, 2013. The Board did not indicate during any past inspection that that the pharmacy's compounded drug products - even those compounded for office use -- were in violation of state law.
3 Notably, in 45 years of operation, to the best of its knowledge, HIC has never had an adverse reaction reported to the FDA. During the February-March 2013 inspection of its facility, FDA also did not cite any contamination of compounded product or identify product that should be recalled because of a lack of assurance of sterility.