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RESPONSE LETTER

People's Custom Rx and Clincal Care, LLC, Company 17/06/2016

People's Custom Rx and Clincal Care, LLC, Company - 498668 - 06/17/2016


Company:
People's Custom Rx and Clincal Care, LLC, Company

 

People's Custom RX
785 Brookhaven Circle East
Memphis, TN 38117
(901) 682-2273
(888) 900-633 7
Fax: (901) 682-4146
 
 
June 17, 2016
 
Department of Health and Human Services
Food and Drug Administration
404 BNA Drive, Building 200, Suite 500
Nashville, Tennessee 37217-2597
 
ATTN: Ruth Dixon, District Director
 
Re: Warning Letter No. 2016-NOL-07 Response, People's Custom Rx and Clinical Care, LLC,
Memphis, Tennessee dated June 06, 2016 and received June 08,2016
 
Dear District Director Dixon:
 
On July 20-24 and 27-29, 2015, the United States Food and Drug Administration (the "FDA") investigators Zada Giles and Mary Millner conducted an inspection of our pharmacy located at 785 Brookhaven Circle East, Memphis, Tennessee 38117-4501. This letter is in response to the FDA Warning Letter No. 2016-NOL-07.
 
I respectfully request that this response, excluding the attachments, be posted on the FDA's website alongside the Form 483 and Warning Letter No. 2016-NOL-07 and be included every time the FDA provides a copy of People's Custom Rx's Form 483 and/or Warning Letter No. 2016-NOL- 07 to anyone outside the FDA. Authorization is given to the FDA to disclose the above mentioned information.
 
As People's Custom Rx has previously stated in our response letter to Form FDA 483, it was never our intent to practice as a 503B outsourcing facility or manufacturer by providing very small numbers of non-sterile compounds to physicians or hospitals "for office use." As far back as August 2014, People's Custom Rx repeatedly requested guidance from the Tennessee Board of Pharmacy, who in tum requested clarification from FDA concerning this issue; however, People's Custom Rx's requests for clarification were left unanswered.
 
People's Custom Rx has taken the following corrective actions as referenced in Warning Letter No. 2016-NOL-07:
 
1.    Immediately following FDA's April 2016 release of "Guidance for Industry, Prescription Requirement Under Section 503 A of the Federal Food, Drug, and Cosmetic Act," People's Custom Rx ceased ALL non-sterile compounding for human use intended "for office use" or "office stock." People's Custom Rx believes that we were able to document to FDA in July of 2015 that our pharmacy only compounds human sterile preparations upon receipt of patient specific prescriptions. The procedure People's Custom Rx follows is outlined in Affidavit Form FDA 463a; therefore, as of April 1, 2016, People's Custom Rx is ONLY compounding human sterile and non-sterile preparations after the receipt of a valid prescription for an identified individual or limited anticipatory compounding based solely on our pharmacy's dispensing history of receiving valid prescription orders. This was confirmed by an internal prescription audit that was conducted on June 9, 2016.
 
2.    SOP No. 3.300.303 "Disinfectant Selection and Use Rotation" was updated to specifically include the classes of agents, stating "Disinfectants from different classes shall be rotated according to their general chemical classification on a monthly basis; classes shall include agents with fungicidal, bactericidal, virucidal, tuberculocidal, mildewecidal, and sporicidal effects." Peridox RTU Sporicidal Disinfectant and Cleaner, by Sporicidin, was ordered on 6/8/2016, was used upon receipt and was added to the monthly rotation of cleaners.
 
Find attached the following documents relating to this action:
a.  SOP 3.300.303 "Disinfectant Selection and Use Rotation"
b.  Form 3.300.303 "Approved Disinfectant Rotation Form"
c.  Information on Peridox RTU Sporicidal Disinfectant and Cleaner
d.  Form 1.400.1 "Standard Operating Procedure Comprehension Form" documenting the sterile compounding staff's education of the change made to this related SOP and Form
 
3.    Following the issuance of Form 483, on 07/30/2015, People's Custom Rx conducted and documented staff re-training/re-education on SOP 3.300.308 "General Aseptic Compounding Procedures When Working within the Secondary Engineering Controls and Primary Engineering Controls" and submitted this information as an attachment along with our response letter to Form 483. However, in order to re-address concerns regarding the FDA's observation that "personnel did not sanitize components used during aseptic production," People's Custom Rx changed SOP 2.100.3 "Procedures for Assessing the Competency of the Compounding Staff on an Ongoing Basis Including Documentation of Training on SOPs" to increase the assessment of the competency of the sterile compounding staff from semi-annually (current USP <797> guidelines) to quarterly for high risk (proposed USP <797> guidelines). Evaluation will include, at minimum, media fill for high risk, glove fingertip testing, didactic testing, assessment of aseptic technique, assessment of hand hygiene and garbing related practices, and assessment of cleaning and disinfection procedures.
 
Find attached the following documents relating to this action:
a.  SOP 2.100.3 "Procedures for Assessing the Competency of the Compounding Staff on an Ongoing Basis Including Documentation of Training on SOPs"
b.  Form: "Validation of Personnel-Aseptic Compounding Techniques Form"
c.  Form 2.100.305 "Assessment of Aseptic Technique and Related Practices of Compounding Personnel Form"
d.  2.100.306 "Assessment of Hand Hygiene and Garbing Related to Practice of Compounding Personnel Form"
e.  Form 3.100.307 "Assessment of Cleaning and Disinfection Form"
f.  Form 1.400.1 "Standard Operating Procedure Comprehension Form" documenting the sterile compounding staff's education of the change made to this related SOP
 
4.    ENV Services Testing and Certification, Inc. reports dated September 23, 2015 and again March 11, 2016 for People's Custom Rx, document that smoke studies were conducted for the ISO 5 hoods under dynamic conditions. ENV Services Testing and Certification, Inc. will continue to include this testing in their report semi-annually.
 
Find attached the following documents relating to this action:
a.  ENV Services Testing and Certification Flow Testing Reports, including Dynamic Smoke Pattern Testing, September 23, 2015
b.  ENV Services Testing and Certification Flow Testing Reports, including Dynamic Smoke Pattern Testing, March 11, 2016
 
5.    People's Custom Rx will also secure a 3rd party consultant with relevant sterile compounding experience to conduct a comprehensive evaluation and assessment of our operations per the suggestion of FDA.
 
People's Custom Rx respectfully submits this response to Warning Letter No. 20 16-NOL-07. People's Custom Rx strives to comply with state and federal pharmacy laws and USP <797> guidelines for compounding sterile products and USP <795> guidelines for compounding non-sterile products, as required by the applicable Tennessee Board of Pharmacy Rules. We remain committed to providing our patients with quality preparations that are safe and effective.
 
Regards,
/S/
William C. Johns, D.Ph.
Owner, People's Custom Rx and Clinical Care, LLC