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VIA Overnight Mail and Fax

RECEIVED
APR 06 2017

March 29, 2017

Jessica L. Kocian, Compliance Officer
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
 

Re: Trone Health Services, Inc. dba Medicap Pharmacy #8362 Response to Warning Letter (WL SEA 17-08)

Dear Ms. Kocian,

Trone Health Services (hereafter referred to as "Medicap Pharmacy") remains committed to complying with all applicable compounding pharmacy laws and regulations, and to providing patients with high-quality and safe compounded preparations.

Background

Medicap Pharmacy has been serving patients and providing patients with access to vital medications for over a decade. Medicap Pharmacy is an Idaho licensed 503A pharmacy and as such operates in accordance with the highest quality and safety standards of the compounding profession and continues to operate in compliance with all applicable Idaho state laws and state regulations, Section 503A of the Drug Quality and Security Act ("Section 530A"), and USP Chapters applicable to compounding. Medicap pharmacy spends considerable effort, time, and resources on maintaining and enhancing its quality assurance and quality control program and will continue to evaluate its overall policies and procedures and revise as necessary to ensure compliance with FDA's expectations in conjunction with those ofthe Idaho Board of Pharmacy.

We appreciate this opportunity to respond to the FDA Warning Letter that was sent on March 22, 2017. The issues stated by the FDA in the Warning Letter are broken into (1) adulterated drug products based on sterile compounding and (2) compounding of Domperidone.

These issues have been addressed and were reported to the FDA investigators during the inspection that occurred from June 27, 2016 to July 15, 2016, and reported again to the FDA on August 3, 2016 in response to the Form 483. As such, to the extent that Medicap Pharmacy's compounding practices allegedly violated certain provisions ofthe FDCA as set forth within the FDA's Form 483 Observations, Medicap Pharmacy addressed the allegations within the response to the Form 483 that has been attached hereto. In addition, we now address each of these issues in turn below.

Sterile Compounding

Medicap pharmacy is a Section 503A pharmacy that only compounds non-sterile preparations solely pursuant to a prescription from a licensed prescriber for an identified individual patient.

The management of Medicap Pharmacy undertook a comprehensive assessment of operations, including facility design, procedures, personnel, processes, materials, and systems beginning in September 2015 and decided to cease all sterile compounding operations as of November 2015. Medicap Pharmacy proceeded to sell the clean room and sterile hood and removed all items needed for sterile compounding. This was witnessed by the FDA investigators during the inspection that occurred on June 27, 2016 to July 15, 2016 and stated again in the response to the Form 483 on August 3, 2016.

FDA acknowledges these facts in the Warning Letter and states, "[w]e acknowledge your statement that your firm has ceased all sterile compounding."

Medicap pharmacy further understands and is aware of the timeframe that FDA expresses in the Warning Letter regarding a 15 day notice to FDA should Medicap ever consider resuming sterile compounding. However, at this time, Medicap does not compound sterile preparations and has no plans to reconvene such activities.

Compounding Domperidone

Compounding of Domperidone was not cited as an observation by the FDA in the form 483 Observations, and as such, Medicap did not have the opportunity to respond to the FDA's observations. By not citing this information as an observation within the Form 483, the FDA eliminated the opportunity for Medicap Pharmacy to provide a response. As such, Medicap Pharmacy will take the opportunity to respond to this observation now.

The FDA alleges in the Warning Letter that Medicap Pharmacy compounded Domperidone on April 2014 and May 2015. Medicap Pharmacy disagrees with FDA's assertion that compounding Domperidone during April 2014 and May 2015 is in violation of the Federal Food Drug and Cosmetic Act and without a thorough review of records does not concede of the compounding in 2014 or 2015. Furthermore, the FDA did not release the guidance entitled "Interim Policy on Compounding using Bulk Drug Substances under Section 503A of the Federal Food, Drug, and Cosmetic Act" where the FDA placed Domperidone onto the API Category 2 list until June 9, 2016.1 As such, Domperidone was not restricted or prohibited from compounding during the timeframes ofthe alleged dates of April 2014 and May 2015 that are stated within the Warning Letter.

Medicap Pharmacy immediately ceased compounding of Domperidone upon FDA's actions against compounding for Domperidone. FDA acknowledges this fact in the Warning Letter and states that the FDA noted compounding ofDomperidone only on April2014 and May 2015 and further notes that "[o]ur review of your records indicates that you have not compounded Domperidone products since that time."

As such, Medicap Pharmacy does not currently compound Domperidone and has no plans to compound Domperidone in the future.

Request for Publication

We respectfully request that Medicap Pharmacy's response to the Form 483 along with Medicap Pharmacy's response to this Warning Letter be posted on the FDA's enforcement activities website. In the event there are any questions regarding the disclosure of such information, I hereby request pre-disclosure notification so that we can address any such questions.

Please do not hesitate to contact me should you have any questions concerning the foregoing.
 

Sincerely,
/S/

Devin R. Trone, Pharm.D.
President
Trone Health Services, Inc. dba Medicap Pharmacy

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1 See FDA "Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, Updated February 1, 2017, Retrieved at
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatorylnformation/PharmacyCompounding/UCM467373.pdf