- Arnold Professional Pharmacy
FIRM and AFFILIATE OFFICES
RACHAEL G. PONTIKES
DIRECT DIAL:+ 1 312 499 6757
PERSONAL FAX: + 1 312 277 6903
May 3, 2017
Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Via E-Mail and USPS
Re: Arnold Professional Pharmacy ("Arnold") Warning Letter Response CMS #521908
Dear Compliance Officer Honeycutt:
We represent Arnold, and hereby submit to the Food and Drug Administration ("FDA") this letter in response to FDA's Warning Letter dated April 7, 2017 ("Warning Letter"). Please note that Arnold received the Warning Letter on April 12, 2017.
We want to emphasize at the outset that Arnold takes the issues identified in the Warning Letter very seriously. As part of its continuing effort to meet the highest standards for compliance and patient safety, Arnold continually reviews its overall operations to ensure that it remains in conformance with all applicable law, including relevant portions of the Federal Food, Drug, and Cosmetic Act ("FDCA") and Maryland state law. To this end, as set forth in Arnold's response to FD A's May 2016 Form 483 ("Form 483"), Arnold addressed all of the observations identified in the Form 483.
Now, in the Warning Letter, for the first time FDA claims that Arnold failed to receive patient-specific prescriptions before dispensing its compounded medications and, therefore, loses the protections of Section 503A. As set forth below, Arnold is currently in full compliance with Section 503A, and qualifies for all of Section 503A's exemptions as Arnold is dispensing compounded medication only pursuant to a patient-specific prescription.
A. FDA Should Not Apply cGMP Standards To Arnold.
Like in the Form 483, in the Warning Letter FDA continues to apply cGMP standards to Arnold. For example, FDA explicitly states that "you must comply with the requirements of section 505 and 502(f)(1) and fully implement corrections that meet the minimum requirements of the CGMP regulations." As stated in its Form 483 Response and within this Response, Arnold is a Maryland state-licensed pharmacy that compounds and dispenses medications that comply with Section 503A of the FDCA ("Section 503A"). It is Arnold's practice to only compound patient-specific medications. Since it is Arnold's practice to compound only pursuant to an individual patient prescription, its medications are compounded in compliance with Section 503A.
B. Arnold Has Addressed All Issues Raised By FDA.
Notwithstanding Arnold's objections, it undertook a comprehensive review and evaluation of its compounding operations. Please note that Arnold's cooperation with FDA should not be interpreted as a waiver of any of the above objections.
In response to both the Warning Letter and Form 483, Arnold addressed the following:
During the inspection, the FDA investigators noted that drug products produced by your firm failed to meet the conditions of section 5 OJA. For example, the investigators noted that your firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced.
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The FDA investigators observed a significant CGMP violation at your facility, causing the ineligible drug products to be adulterated within the meaning of section 501 (a)(2)(B) of the FDCA. Specifically, your firm's testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications and identity and strength of each active ingredient prior to release (21CFR211.165(a)].
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We have reviewed your firm's responses to the Form FDA 483. Your response states that your firm "customarily sends out one randomly sampled compound per month for testing. " This response is deficient because it suggests that not all produced batches of non-patient specific compounded drug products are tested for strength before release.
As explained above, receipt of valid prescriptions for individually-identified patients is a condition of section 503A, which your firm failed to meet for a portion of the drug products you produced. Should you continue to compound and distribute drug products that do not meet the conditions of section 503A, the compounding and distribution of such drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the drug CGMP regulations. Before doing so, you must comply with the requirements of section 505 and 502(f)(1) and fully implement corrections that meet the minimum requirements of the CGMP regulations.
Arnold reincorporates its response to the Form 483, and objects to this observation because it mischaracterizes the observations set forth in the Form 483 and attempts to hold the pharmacy to a standard that is inapplicable under Section 503A. Specifically, the Form 483 does not state anywhere that "your firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced." As set forth above, it is Arnold's practice to only dispense compounded medication pursuant to a patient-specific prescription, and therefore Arnold qualifies for Section 503A's exemption from cGMP requirements.
This observation further attempts to impose onto Arnold cGMP requirements for batch testing to ensure consistency and potency. The cGMP requirements of consistency and potency batch testing do not apply to Arnold. Instead, Arnold is required to comply with state law and standards found in the applicable United States Pharmacopeia ("USP").
Under USP <795>, Arnold is not required to do batch testing to ensure consistency and potency of its nonsterile compounds. Instead, USP <795> sets out the following requirements for quality control for nonsterile preparations.
The safety, quality, and performance of compounded preparations depend on correct ingredients and calculations, accurate and precise measurements, appropriate formulation conditions and procedures, and prudent pharmaceutical judgment. As a final check, the compounder shall review each procedure in the compounding process. To ensure accuracy and completeness, the compounder shall observe the finished preparation to ensure that it appears as expected and shall investigate any discrepancies and take appropriate corrective action before the prescription is dispensed to the patient.
Arnold's quality control process for its nonsterile compounded preparations meets all of the above requirements. Specifically, Arnold reviews as a final check each procedure in the compounding process, observes the finished preparation to ensure that it appears as expected, and investigates any discrepancies to take appropriate corrective actions. Arnold then goes beyond USP <795> requirements and customarily sends out one randomly-sampled compound per month for testing. To date, Arnold has not had a sample come back out of acceptable range. There have also not been any complaints made directly to the pharmacy from patients or the Maryland Board of Pharmacy regarding consistency or lack of potency. As such, Arnold's current quality control process for its nonsterile compounded preparations meets and exceeds the USP <795> requirements.
In closing, we would like to emphasize that Arnold takes compliance with all applicable federal and state laws governing its pharmacy practice very seriously. Arnold shares FDA's goal of ensuring that patients in need of custom compounded medications receive the highest quality preparations. To that end, we respectfully request that FDA issue a closeout letter without delay.
Very truly yours,
Rachael G. Pontikes