- Reference #:
- Foothills Professional Pharmacy, LTD
4545 E. Chandler Blvd. #100
Phoenix, AZ 85048
- Division of Pharmaceutical Quality Operations IV
FOOTHILLS PROFESSIONAL PHARMACY, LTD.
September 22, 2020
Via Certified Mail
Return Receipt Requested
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
19701 Fairchild Road
Irvine, CA 92612
Re: RESPONSE TO WARNING LETTER (CMS #598883)
Foothills Professional Pharmacy, LLC
4545 E. Chandler Blvd, Ste. 100
Phoenix, AZ 85048
Dates of inspection: 7/9/2018 - 10/24/2018
Dear Mr. Porter,
We are writing in response to the Warning Letter issued by the U.S. Food and Drug Administration ("FDA") on September 9, 2020, pertaining to the inspection of Foothills Professional Pharmacy, Ltd., located at 4545 E. Chandler Blvd, Ste. 100, Phoenix, AZ 85048. The inspection was conducted between July 9, 2018, and October 24, 2018. We request that this response be included with the Warning Letter any time FDA provides a copy of the Warning Letter to anyone outside FDA, otherwise publishes the Warning Letter, or when/if the Warning Letter is posted online.
Before addressing the comments set forth in FDA's Warning Letter, Foothills Professional Pharmacy would like to reiterate that it is a compounding pharmacy subject to the jurisdiction of the Arizona Board of Pharmacy. Moreover, Foothills Professional Pharmacy is solely engaged in the preparation of non-sterile drug products. It does not engage in any sterile compounding of any kind. Patient safety is a top priority of the staff and management at Foothills Professional Pharmacy. Foothills Professional Pharmacy complies with USP <795> and other rules and regulations promulgated by the Arizona Legislature and Arizona Board of Pharmacy, which expressly permit office-use compounding.
Foothills Professional Pharmacy understands that FDA maintains authority to regulate the manufacture of drugs. However, Foothills Professional Pharmacy does not manufacture drugs. Rather, Foothills Professional Pharmacy is a retail compounding pharmacy that is regularly engaged in dispensing prescription drugs upon the prescriptions of licensed practitioners, as contemplated by Section 503A of the Food, Drug & Cosmetics Act ("FDCA"). Foothills Professional Pharmacy is required to, and does, comply with regulations that are applicable to Arizona non-sterile compounding pharmacies, not with those applicable to drug manufacturers, which include current good manufacturing practices ("CGMPs"). To the extent that the comments set forth in the Warning Letter are based on CGMP requirements, Foothills Professional Pharmacy disagrees that they apply to Foothills Professional Pharmacy or constitute violations of the FDCA.
While Foothills Professional Pharmacy does not concede that the CGMP requirements upon which some of FDA's comments are based apply to its non-sterile compounding activities, in the interest of patient safety and continuous quality improvement, we have taken the opportunity to evaluate our pharmacy procedures and, where appropriate, have implemented measures in an effort to continue to ensure the highest quality in our compounding operations.
We provide the following response to the comments set forth in FDA's Warning Letter:
Failure to Meet the Conditions of Section 503A
The Warning Letter notes that Foothills Professional Pharmacy did not receive valid prescriptions for individually identified patients for certain non-sterile, topical pain creams, specifically Lidocaine/Tetracaine/Phenylepherine in Poly-Poloxamer 23%/7%/0.8% Gel and Benzocaine/Lidocaine/Tetracaine/Phenylephrine 20/6/4/0.5% (b)(4). The Warning Letter contends that those compounded drug products do not meet the conditions of Section 503A and are not eligible for the exemptions in that section. As FDA is aware, Arizona law expressly allows pharmacies to compound drugs for office or hospital administration. The above-referenced non-sterile, topical pain creams were compounded and distributed to healthcare providers for in-office administration in full compliance with Arizona law. FDA's interpretation of Section 503A as prohibiting office-use compounding is contrary to the language of Section 503A, historical compounding practices, state law, and Congressional intent. (See e.g., Congressional Record, Vol. 159, No. 162, at S0829). On several occasions, the Senate Committee on Appropriations has specifically criticized FDA for its knowing misinterpretation of Section 503A and its improper attempts to prohibit office-use compounding. (See House Report, 114-205, FY 2016; House Report, 115-523, FY 2018). Notwithstanding the lack of statutory support for FDA's prohibition of office-use compounding and notwithstanding the fact that office-use compounding continues to be authorized under Arizona, Foothills Professional Pharmacy ceased all office-use compounding, effective July 9, 2018 - more than two years before FDA issued its present Warning Letter.
Violations of the FDCA
1. Apparent loose powder and dried product splatter inside hoods within each production room while drug products were being produced.
As stated in our November 14, 2018 response to the Form FDA-483, Foothills Professional Pharmacy promptly re-trained its staff on proper cleaning procedures and good compounding practices and re-emphasized the importance of ensuring that equipment and utensils used in compounding are cleaned and protected from contamination before use; inspecting and determining that they are suitable for use before initiation of compounding operations; and are routinely inspected, calibrated, or checked to make proper performance certain, all as specified by Arizona law. Foothills Professional Pharmacy previously provided FDA with documentation showing such re-training along with its response to Form FDA-483.
2. Household brand blenders were used to (b)(4) for use in the production of capsules. Mixing cups for the household brand blenders were damaged and discolored. In addition, loose powder and a dry white substance were observed on equipment used to (b)(4) produce capsules including retail gift cards used to scrape powder into capsules. Silicone mixing blades used for cream production contained multiple discolored cracks. Apparent loose powder and a semi-dry smeared substances were observed on multiple pieces of equipment designated as "clean" and used for cream production.
As stated in our November 14, 2018 response to the Form FDA-483, Foothills Professional Pharmacy promptly inspected and replaced any mixing cups that appeared worn, damaged, or discolored. In addition, Foothills Professional Pharmacy re-trained its staff on proper cleaning procedures and good compounding practices and re-emphasized the importance of insuring that equipment and utensils used in compounding are cleaned and protected from contamination before use; inspecting and determining that they are suitable for use before initiation of compounding operations; and are routinely inspected, calibrated, or checked to make proper performance certain, all as specified by Arizona law. Foothills Professional Pharmacy provided FDA with documentation showing such re-training along with its response to Form FDA-483.
3. Your firm did not use adequate deactivation agents in the production areas to prevent potential cross-contamination.
As stated in our November 14, 2018 response to the Form FDA-483, Foothills Professional Pharmacy promptly re-trained it staff on the use of proper cleaning agents and, specifically, SOP 1.25, a copy of which was provided to FDA. No substitution of the specified cleaning agents or concentrations are permitted. Since the inspection, Foothills Professional Pharmacy's staff has used only (b)(4) as its primary cleaning and deactivation agent as directed by the FDA inspectors. In response to the concern raised by FDA in its Warning Letter that SOP 1.25 permit the use of "(b)(4) ... or other (b)(4)" and "(b)(4) or other (b)(4), Foothills Professional Pharmacy has now further revised SOP 1.25 to reflect it actual practice of using only (b)(4) and has re-trained its staff on this clarification, accordingly. A copy of revised SOP 1.25 and training documentation are enclosed.
Production of Domperidone
As explained to the FDA inspectors during the inspection. Foothills Professional Pharmacy only compounded a single, veterinary domperidone product, one time only for a single veterinary patient as requested by a veterinarian pursuant to a patient-specific prescription. Foothills Professional Pharmacy has not compounded any other domperidone products since that time nor does it have any intentions of doing so in the future.
CGMP Violation related to Ineligible Drug Products
As stated above FDA"s prohibition of office-use compounding is contrary to the language of Section 503A, historical compounding practices, state law, and Congressional intent. Foothills Professional Pharmacy's non-sterile compounding activities are governed by Arizona state law, with which Foothills Professional Pharmacy is in full compliance. CGMP does not apply to Foothills Professional Pharmacy's compounding activities and therefore, Foothills Professional Pharmacy is not in violation of any CGMP standards.
The only corrective action requested by FDA in its Warning Letter is a request for clarification concerning its use of cleaning and deactivation agents. As noted above. since FDA's 2018 inspection Foothills Professional Pharmacy staff has only used (b)(4) as its primary cleaning and deactivation agent. Foothills Professional Pharmacy has further updated its SOP 1.25 to clarify that only (b)(4) is to be used as a cleaning and deactivation agent and has re-trained its staff as to this clarification. A copy of revised SOP 1.25 and training documentation are enclosed.
If FDA desires additional information or documentation relating to any of the foregoing Warning Letter responses, please let me know and we will gladly supplement this response according.
Pujan Patel, President
Foothill Professional Pharmacy
4545 E. ChandIer Blvd. #100
Phoenix, AZ 85048