- Village Fertility Pharmacy, Inc.
VILLAGE FERTILITY PHARMACY
HELPING MAKE FERTILITY EASIER
MARCH 14, 2014
Food and Drug Administration
New England District Office
Attn: Miguel Hernandez
One Montvale Ave, 4th Floor
Stoneham, MA 02180
RE: Warning Letter CMS# 398380 Response
Dear Mr. Hernandez
Village Fertility Pharmacy (Village) is in receipt of a warning letter received on March 3, 2014 regarding an inspection conducted by the Food and Drug Administration (FDA), between February 21, 2013 and March 13, 2013 in which a form 483 was issued with noted observations.
Many of the observations were related to medium and high risk compounding for which the FDA is aware, as noted in section (B) Corrective Action that Village no longer produces medium or high-risk sterile drug products, nor intends to in the future. However, should that change, Village will take the appropriate actions and submit all formal notifications.
As the FDA is aware, Village Pharmacy also agreed in the Agreed Plan of Action with the MA Board of Pharmacy (Board) not to engage in low risk sterile compounding until it obtains Board approval after submitting documentation to the Board of (i) certification that the ante and barrier rooms insure compliance with USP 797, (ii) written policies and procedures regarding the provision of low risk sterile compounding, (iii) evidence of staff training required for low risk sterile compounding per USP 797, and (iv) evidence of staff training for ongoing clean room maintenance.
Therefore Village Pharmacy has agreed, and will continue to so agree, with the operational requirements of the Board, which should also meet the required corrective actions of the FDA 483 and associated warning letter CMS # 398380.
The Investigative Report dated March 13, 2013, which apparently is the basis of the proposed FDA action cites a number of alleged deficiencies, some of which are only relevant to high risk sterile compounding, and others which apply to the overall operation of the pharmacy. All of these matters have been addressed by Village Pharmacy.
The matters only relevant to high risk sterile compounding have been addressed by the fact that no high risk sterile compounding is being, or will be, performed since there is no high risk compounding occurring, vials and stoppers are not being used. There is no issue of sterilization or sterility testing with respect to high risk sterile compounds since no high risk sterile compounding is being performed. The proper use of the dry heat oven is no longer an issue since its use has been completely discontinued. Similarly the BAXA pump is no longer being used. Micron Nalgene filters are no longer being used.
Each of the matters that apply to the overall operation of the pharmacy have also been addressed. Specifically, (a) the evaluation and documentation of product integrity incident reports of patients and healthcare practitioners is now standard operational procedure as is root cause analysis and appropriate corrective or preventative actions to prevent future problems, (b) static or dynamic smoke studies on the ISO hood are now being performed by an outside vendor, as is dynamic air and surface testing on a monthly basis, and a magnehelic gauge in the buffer room has been purchased and is operational, (c ) technicians are being retrained with respect to following proper protocols and documentation in compounding products, including with respect to batch records, (d) the facility cleaning process has been revamped, (e) performance and documentation of environmental and personnel monitoring is occurring, and (f) media fills are being performed to simulate sterile compounding operations. All of these issues have been addressed (i) thorough and intensive training of all personnel, (ii) the use of consultants, (iii) the hiring of a full time compliance officer to address and assure quality and compliance, (iv) the hiring of a full time additional pharmacist specifically to manage the clean room and supervise technicians, and (v) Village Pharmacy’s application for URAC Certification and PCAB Accreditation.
1. Training. Village Pharmacy engaged the Medisca Network to provide ACPE accredited pharmacy compounding training to three licensed pharmacists, one pharmacy intern and two technicians at Village Pharmacy’s facility. Additionally, Village Pharmacy has purchased an ACPE accredited self-study program of approximately 30 hours. Village Pharmacy has also purchased the CriticalPoint’s eLearning Educational Program which is a comprehensive online training on sterile compounding developed specifically to meet the USP 797 training standards.
2. Compliance. Village Pharmacy hired a Compliance Officer for the purpose of having one professional, not directly involved in traditional pharmacy operations, responsible for monitoring, training, and assuring compliance. David Brass, the Compliance Officer, has 17 years of quality assurance and compliance experience in healthcare. His resume will be supplied on request. Village Pharmacy has also hired an additional pharmacist, whose responsibility will be to manage the clean room and assure compliance with USP 797. Finally, Village Pharmacy has purchased Simplifi 797 software which provides a streamlined software workflow to assure 797 compliance, and Ninth Brain Suite software which provides streamline access to training, licensing, electronic forms, and trending data.
3. Certification and Accreditation. Village Pharmacy is seeking URAC Certification and PCAB Accreditation for the purpose of assuring compliance with both federal and state requirements. PCAB standards are a set of compounding quality and safety best practices. Village Pharmacy engaged BHM Healthcare Solutions, a consulting company specializing in compliance matters, to help it with URAC Certification, and Gates Healthcare Associates, Inc. to assist with PCAB accreditation.
In short, in order to assure both itself, FDA and the Board of continuing full compliance with USP 797 operating standards, Village Pharmacy has committed to annual expenditures of over $300,000 for two full time professionals, outside consultants, continual staff training and additional certification and accreditation.
In conclusion, Village is and continues to be compliant with USP 797 standards, and has gone above and beyond in many areas such as cleanroom surface and air sample testing, in addition to many other areas of testing and education in an effort to maintain the highest quality standards possible.
There has been a comprehensive assessment of the facility, procedures, personnel, materials, systems, environmental monitoring, and aseptic process operations. In addition to routine monitoring to assess aseptic practices of compounding personnel.
Included with this response, are two MA board of Pharmacy inspections dated July 16, 2013 which was an inspection prior to the reopening of the cleanroom, and another, which was a surprise inspection dated February 27, 2014. Both of which show no deficiencies. In addition to the inspection reports, also included, is a sample of our cleaning policies, training records, and Simplifi reports on cleaning and fingertip testing as supporting documentation of our continued compliance. Further documentation will be submitted upon request.
QUALITY ASSURANCE/COMPLIANCE MANAGER
VILLAGE FERTILITY PHARMACY, INC.
335 BEAR HILL RD, WALTHAM, MA 02451
877-334-1610 EXT. 4111