Inspections, Compliance, Enforcement, and Criminal Investigations
Oakdell Pharmacy Inc Company Response 6/18/14
Jeff Carson, R.Ph.
Oakdell Pharmacy, LLC
7220 Louis Pasteur
San Antonio, TX 78229
June 18, 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 (Oakdell Pharmacy, Inc.)
Dated May 27, 2014; Ref. 2014-DAL-WL-04
Dear Ms. Ashley:
We are in receipt of FDA's Warning Letter dated May 27, 2014. Oakdell Pharmacy, LLC (Oakdell), is a second generation, family and pharmacist-owned compounding pharmacy and a small business located in San Antonio, Texas. My father, John R. Carson, opened the pharmacy over 40 years ago in February of 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 (IACP) for a number of years. I was also awarded one of the most prestigious honors a compounding pharmacist can receive - the Professional Compounding Centers of America (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 Title I of the Drug Quality and Security Act,the Compounding Quality Act, Pub. L. No. 113-54 (CQA), on November 27, 2013.
Oakdell's Response to FDA's May 27, 2014 Warning Letter
FDA's inspection that is the subject of FDA's Form 483 Observations and its recent Warning Letter occurred from February 26 to March 1, 2013. Although FDA conducted an additional inspection in early January 2014, FDA did not issue Form 483 Inspection Observations after the second inspection, thus depriving Oakdell of any opportunity to respond to, remediate, or otherwise immediately correct any observations found during that subsequent inspection.
FDA's first inspection of Oakdell occurred almost nine months prior to the November 27, 2013 enactment of the CQA. As we asserted in response to FDA's Warning Letter issued to Home Intensive Care (HIC) Pharmacy, 1 Oakdell respectfully asserts that FDA's allegations as to Oakdell are also factually and legally unjustified.
FDA's statement in its May 27, 2014 Warning Letter that Section 503A applied to Oakdell when it inspected the pharmacy back in February and March 2013 is inconsistent with FDA's own Commissioner, Dr. Margaret Hamburg's, Congressional testimony concerning FDA's enforcement authority against compounders on April 16, 2013 - merely a month after the inspection of Oakdell. During that Congressional hearing, Dr. Hamburg testified that FDA's enforcement authority over compounding pharmacies was "hampered by gaps and ambiguities" in the law, "unclear," "ambiguous," "and the law is not well suited to effectively regulate this evolving industry." Subcommittee on Oversight and Investigations, "A Continuing Investigation into the Fungal Meningitis Outbreak and Whether It Could Have Been Prevented," testimony of Margaret A. Hamburg, M.D., at 3, 6 (April 16, 2013).
FDA's position with respect to Oakdell similarly 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, Oakdell has always engaged in significant measures to ensure that any office use compounding that it performed complied with applicable state laws. Its actions were and are consistent with the Texas State Board of Pharmacy regulations currently in effect, and which were in effect during the relevant time period, including the time that the pharmacy was inspected by FDA in February and March of 2013.
It is similarly inexplicable that FDA's Commissioner would specifically and publicly use the terms "unclear" and "ambiguous" to describe its enforcement authority a mere few weeks after its inspection of Oakdell, and now assert that Oakdell has violated the misbranding, adulteration and cGMP provisions of the FDCA because it engaged in office use compounding under that same authority - and when such activities were specifically permitted by Texas state law at the time of the 2013 inspection. As stated in response to the FDA Form 483 Inspection Observations that Oakdell received (see Responses to Observations dated April 12, 2013), Oakdell has acted in compliance with state laws (permitting office use compounding), and its compounding practices are consistent with United States Pharmacopeia guidelines. To the extent that Oakdell's compounding practices were allegedly violative of certain provisions of the FDCA as set forth in FDA's 2013 Form 483 Observations, the pharmacy addressed those alleged violations in its responses thereto. Oakdell's April 2013 Form 483 Responses are attached.
Specific Allegations in FDA's May 27, 2014 Warning Letter
Not only did Oakdell address the allegations raised in the FDA's 2013 Form 483 Observations, but Oakdell also addressed the allegations raised in FDA's May 27, 2014 Warning Letter. For example, FDA alleged that the "'ISO 5' workbenches are constructed from particle board with a laminated surface." Oakdell replaced the workbenches with stainless steel tops. FDA also observed "a technician wearing a non-sterile laboratory coat, with exposed skin (forehead and neck), and resting his elbows on the bench top of the 'ISO 5' workbench while performing aseptic processing of ophthalmic drops." In response to the Observation, Oakdell retrained its employees on aseptic procedures and revised its policies and procedures concerning aseptic technique. Oakdell's revised policies will be provided upon request.
All of the remaining six specific, numbered allegations in the May 27th Warning Letter cite violations of various parts of 21 C.F.R. Part 211. This part of the Code of Federal Regulations is applicable to drug manufacturers, which are held to current good manufacturing practices. These cGMP standards simply should not apply to a compounder of drug preparations, especially for the time period when FDA admitted that its own laws were at best ambiguous, and prior to when Congress passed the CQA. Since passage of the CQA, and since FDA issued its Warning Letter to HIC earlier this year, Oakdell has endeavored diligently to transition from office use compounding. At the time of the January 6, 2014 FDA inspection of Oakdell (which was barely a month after passage of the Act), Oakdell understandably had not yet completed the transition of its long-standing customer base to fill prescriptions for identified patients only. Oakdell had been performing compounding in accordance with Texas state laws (including those permitting office use compounding) for customers for dozens of years (specifically, since 1969), and it had to transition to a new business model consistent with the CQA. That transition is now complete.
The Future of Compounding Drug Preparations at Oakdell; 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, Oakdell intends to comply with the newly enacted CQA, as demonstrated by its elimination of office use compounding and commitment to compounding preparations pursuant to prescriptions for individually identified patients. Oakdell will not be registering as an Outsourcing Facility under newly enacted Section 503B, and thus will not be engaged in Outsourcing Facility activities, such as sterile compounding for office use, which activities are otherwise permissible by Outsourcing Facilities under certain conditions set forth in Section 503B.
Instead, Oakdell has refocused its operations so that it engages in compounding for individually identified patients pursuant to a valid prescription or order in accordance with Section 503A, regardless of Texas's state law, which still permits office use compounding. As such, Oakdell should be subject to the exemptions set forth in Section 503A, including an exemption from Section 501 (a)(2)(B) (cGMP). Oakdell believes there is still substantial controversy surrounding the statutory permissibility of traditional office use compounding, which has been performed by pharmacists since the creation of the Apothecary. Nevertheless, based on the new federal law creating Outsourcing Facilities (Section 503B) as well as revitalized Section 503A-it has ceased non-patient specific compounding. Since approximately mid-February 2014, Oakdell has compounded preparations only for individually identified patients.
In 45 years of operation, Oakdell 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 still permitted under state law (but which activity Oakdell no longer performs). The FDA's assertions in its May 27, 2014 Warning Letter are based not on any analysis or sterility testing of Oakdell's compounded products whatsoever, but instead on the fact that Oakdell's compounded office use preparations did not comply with federal cGMP requirements for drug manufacturers. Oakdell, like HIC, is not a drug manufacturer; nor is it a newly-created Outsourcing Facility. During the February-March 2013 inspection, FDA did not cite any contamination of compounded drug product or identify products that should have been recalled because of a lack of assurance of sterility.
Oakdell respectfully asserts that it engaged in corrective actions concerning FDA's findings in the Form 483 Observations and its Warning Letter, and has, in any event, stopped office use compounding and is acting in compliance with the Section 503A. Oakdell respectfully requests that its responses to FDA's Form 483 Observations, along with its response to this Warning Letter, be posted on 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.
Oakdell Pharmacy, LLC
1 Both Oakdell and HIC are owned by John R. Carson, a pharmacist that has been in business in the San Antonio, Texas area, including providing prescription compounded preparations, for over 40 years.
cc: Reynaldo Rodriguez, Dallas District Director, FDA