- Techni Med, Inc. dba The Compounder
CARING FOR YOUR HEALTH
340 Marshall Ave #100- Aurora. IL 60506
ph: 630-859-0333 - fx: 630-859-0114
August 18, 2016
Russell Riley, Compliance Officer
Food and Drug Administration
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661
Via E-mail email@example.com
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Re: Response to Warning Letter Issued July, 29, 2016, to
Techni-Med, Inc. d/b/a The Compounder
Unique Identification Number: CMS # 493750
Dear Mr. Riley:
The Food and Drug Administration ("FDA") conducted an inspection of our Pharmacy, Techni-Med, Inc. d/b/a The Compounder, between May 6, 2015, and July 9, 2015. Following its inspection, we received a FDA Form 483 identifying ten observations. We responded to the FDA regarding its observations on July 29, 2015 (the "Response Letter"). In our Response Letter, we detailed the implementation of numerous best practices to provide further assurances to the FDA of the safety of our sterile drug products. We subsequently received an FDA Warning Letter, dated July 29, 2016 (the "Warning Letter").
Please accept this letter and the accompanying exhibit as our formal response to the issued Warning Letter. As with the Response Letter, we respectfully request that this letter, excluding the exhibit, be published on the FDA's website next to the Warning Letter and be included every time the FDA provides a copy of such document to a person or entity outside of the agency.
Amended FDA Form 483
As a preliminary matter, we would like to bring to your attention the Warning Letter's reference to an amended FDA Form 483 allegedly issued to us on August 12, 2015, which was subsequent to our submission of the Response Letter. Our records do not reflect receipt of such a document. In addition, the FDA's website does not indicate that an amended FDA Form 483 was issued. Further still, despite several attempts to contact the FDA to obtain this document, we have yet to receive a copy of the amended FDA Form 483. Failure to furnish the amended FDA Form 483 denies us of our right, in accordance with published FDA regulations, to fully respond to the observations cited within the FDA Form 483. Accordingly, we request that we be immediately provided with the amended FDA Form 483 detailed in the Warning Letter.
In its Warning Letter, the FDA states that "the drugs you compound without valid prescriptions for individually-identified patients and any drug products you compound using domperidone are not entitled to the exemptions in section 503A" and, as a result, "are unapproved new drugs and misbranded drugs" in violation of the FDCA. We have ceased compounding activities using domperidone as of April 7th, 2015.
As we stated in our Response Letter, we are a traditional retail pharmacy licensed by the Illinois Board of Pharmacy. While we compound limited quantities (less than 5% of our total prescriptions) of medications for office-use by local Illinois practitioners in the clinic setting, such a practice is expressly permitted by the Illinois Board of Pharmacy. Specifically, 68 Ill. Admin. Code § 1330.640(i) states that the "pharmacy may compound drug products to be used by practitioners in their office for administration to patients." As the practice of compounding for office-use is permitted and regulated by the state Board of Pharmacy, such a practice should also be excluded from FDA oversight in accordance with Congress's repeated instructions to the FDA. Most recently, on June 20, 2016, Congress stated in a letter to the Commissioner of the FDA that "[i]t is unacceptable that the FDA would ignore the Congress and continue to take the position that Section 503A specifically prohibits office-use compounding, despite clear congressional intent to the contrary and despite previous FDA actions that directly contradict that position, including the recent statement by Health and Human Services Secretary Burwell that also directly conflicts with FDA's current position on 'office-use. "'1 As a pharmacy that neither engages in drug manufacturing nor is registered as a 503B outsourcing facility, it is improper to deny us the exemptions afforded to traditional retail pharmacies under section 503A of the FDCA in light of Congress' intent.
The Warning Letter states that drugs compounded at our pharmacy may have been "adulterated" under section 501(a)(2)(A) of the FDCA, which provides that a "drug or device shall be deemed to be adulterated .. .if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health... ." The FDCA does not further define what constitutes "insanitary conditions." FDA guidance on compounding practices has been typically restricted to CGMPs, which are applicable to drug manufacturers but which are inapplicable to our pharmacy operations as a traditional pharmacy, as discussed above. Thus, to the extent that the FDA alleges a violation of Section 501(a)(2)(A) of the FDCA solely by alleging noncompliance with the FDA's CGMPs, we maintain that the indirect application of requirements to which it is exempt by statute is improper.
In any event, the outstanding issues identified in the Warning Letter have also been addressed by our current policies and procedures to the extent that such observations constitute a "best practice" that, if adopted, would benefit the safety of our patients. While the FDA states in its Warning Letter that "[s]everal of the proposed corrective actions appear adequate," it also describes three proposed best practices previously detailed in the Response Letter as "deficient." We now address each of the FDA's outstanding concerns, along with our corresponding responses and actions, in detail below.
First, the FDA acknowledges that we committed to "complete certification with dynamic unidirectional airflow studies on or before December 31, 2016." However, the FDA states that the Response Letter "does not address any interim actions to be put into place prior to the completed certification." Please note that on April 20, 2016, we hired a third party vendor to conduct smoke studies compliant with United States Pharmacopeia ("USP") <797> for our two hoods. Videos documenting the performance of the smoke studies are provided in the enclosed thumb drive for your review. As the videos both document, the smoke studies were performed under dynamic conditions and clearly document that airflow is unidirectional so as to provide adequate protection of the ISO 5 areas in which sterile drugs are compounded. Smoke studies are scheduled to be performed again in early October. We are committed to having such studies performed on a bi-annual basis in accordance with the requirements of USP <797>.
Second, the FDA states that "it is not clear based on your response how your firm will ensure the dry heat cycle is adequate to sterilize and depyrogenate items." As explained on page 7 of the Response Letter, our pharmacy no longer utilizes a dry heat sterilization process. Rather, as of July 23,2015, we have sterilized compounded products by filtration. This practice is permitted by USP guidance, which recommends five methods for the terminal sterilization of drug products, including sterilization by filtration. In compliance with the USP requirements for sterilization by filtration, we now use commercially available sterile 0.2 micron filters. We document the use of a filter by placing the identifying label of the filter used on the formula log for every drug we compound. A sample of a formula log and the associated potency report are provided for your review as Exhibit A. As we no longer employ dry heat or the use of a convection oven to ensure sterility, we believe that the FDA's concern to our observation has been sufficiently addressed.
Last, the FDA notes that the Response Letter failed to include an "evaluation of products previously produced under the observed inadequate conditions." Please note that following the FDA inspection, we conducted a thorough review of our pharmacy operations, particularly as they relate to our sterile drug compounding. As a result of our review, we have implemented changes and best practices, as set out in our Response Letter, where necessary to further assure the safety and sterility of our products. Our actions were determined within the limitations that our compounded drugs are prepared for set quantities and contain specific expiration dates. To the extent that the FDA finds deficiencies in our actions, we have sought to correct them herein.
We believe that this letter, and the actions detailed herein, clearly demonstrate our commitment to patient safety and adequately address the FDA's concerns regarding our pharmacy operations. However, should additional information be necessary, please do not hesitate to contact me at 630-859-0333.
Larry J. Frieders, R.Ph
1 Letter from Chris Stewart, et al., to Dr. Robert M. Califf, M.D., Commissioner, U.S. Food and Drug Administration (June 20, 2016).