COMMONWEALTH OF MASSACHUSETTS

SUFFOLK COUNTY                                                                BOARD OF REGISTRATION 
                                                                                                    IN PHARMACY

In the Matter of       			            )		    PHA-2013-0020           
VILLAGE FERTILITY PHARMACY	)
335 Bear Hill Road				)
Waltham, MA  				)

CONSENT AGREEMENT FOR PROBATION

The Massachusetts Board of Registration in Pharmacy (“Board”) and Village Fertility Pharmacy
(“Village Fertility” or “Licensee”), DS89658, 335 Bear Hill Road, Waltham, Massachusetts, do 
hereby stipulate and agree that the following information shall be entered into and become a 
permanent part of Village Fertility’s record maintained by the Board:

1.   Village Fertility acknowledges that a complaint has been opened by the Board against its 
      Massachusetts pharmacy license related to the conduct set forth in Paragraph 2, identified as 
      Docket No. PHA-2013-0020.  

2.	The Board and Village Fertility acknowledge and agree to the following facts:

a.	Board investigators conducted an unannounced inspection of Village Fertility on or about 
November 26 & 27, 2012. During the inspection, Board investigators observed 
deficiencies pertaining to the compounding of sterile medications, including violations of 
United States Pharmacopoeia (“USP”) Chapter 797 standards.  Additionally, investigators 
noted that Village Fertility was not appropriately licensed in states other than 
Massachusetts into which it shipped medications.

b.	 As a result of the November 2012 inspection, Village Fertility was required to submit a 
plan of correction to the Board. 

c.	On or about February 20, 2013, Village Fertility informed the Board that it received a 
customer complaint of visible black particulate matter in vial of sterile compounded 
product.  As a result, Board investigators inspected Village Fertility on or about February 
21, 22, 25, and 28, 2013 (“February 2013 inspection”).

d.	During the February 2013 inspection, Board investigators observed Village Fertility to be 
non-compliant with 247 CMR 9.01 and United States Pharmacopoeia (“USP”) Standard
<797> Pharmaceutical Compounding – Sterile Preparations, with regard to its 
compounding of sterile medications. Additionally, Village Fertility acknowledges that, 
between at least November 2012 and February 2013, it shipped compounded sterile 
products into states in which it did not hold required non-resident licenses.

e.	On or about April 26, 2013, the Board approved Village Fertility’s written plan of 
correction dated April 2, 2013 to resume the compounding of low risk sterile products.  

3.   Village Fertility agrees that its pharmacy license shall be placed on PROBATION for 36 
      months (“Probationary Period”), commencing with the date on which the Board signs this 
      Agreement (“Effective Date”). 

4.   Village Fertility agrees that all pharmacists and pharmacy technicians working at Village 
      Fertility in any capacity shall each complete five contact hours of continuing education in 
      sterile compounding on or before December 31, 2013.

5.	During the Probationary Period, the Village Fertility further agrees that it shall comply in all 
material respects with all laws and regulations governing the practice of pharmacy and the 
United States Pharmacopeia.

6.	Village Fertility agrees to refrain from all medium and high risk sterile compounding unless 
and until it receives written approval from the Board to resume the preparation and dispensing 
of medium and high risk sterile compounded medications.  Board approval shall not be 
granted unless and until Village Fertility demonstrates, upon inspection by Board 
investigators, that it is fully compliant with United States Pharmacopeia standards pertaining 
to medium and high risk sterile compounding and all other state and federal laws and
regulations pertaining to the practice of pharmacy. 

7.	The Board agrees that in return for Village Fertility’s execution and successful compliance 
with the requirements of this Agreement it will not prosecute the Complaint.  

8.	If the Licensee has complied to the Board’s satisfaction with all the requirements contained in
this Agreement, the Probationary Period will terminate 36 months after the Effective Date 
upon written notice to the Licensee from the Board.

9.	If the Licensee does not materially comply with each requirement of this Agreement, or if the 
Board opens a Subsequent Complaint during the Probationary Period, the Licensee agrees to 
the following:

a.	The Board may upon written notice to the Licensee, as warranted to protect the public 
      health, safety, or welfare:

i.	EXTEND the Probationary Period; and/or
ii.	MODIFY the Probation Agreement requirements; and/or
iii.	IMMEDIATELY SUSPEND the Licensee’s pharmacy license.

b.	If the Board suspends the Village Fertility’s pharmacy license pursuant to Paragraph 
            9(a)(iii), the suspension shall remain in effect until:
i.	the Board provides Village Fertility written notice that the Probationary Period is to be 
resumed and under what terms; or
ii.	the Board and Village Fertility sign a subsequent agreement; or
iii.	the Board issues a written final decision and order following adjudication of the 
      allegations (1) of noncompliance with this Agreement, and/ or (2) contained in the 
Subsequent Complaint.

10.	Village Fertility agrees that if the Board suspends its pharmacy license in accordance with 
Paragraph 9, it will immediately return its current Massachusetts pharmacy license to the 
Board, by hand or certified mail.  Village Fertility further agrees that upon said suspension, 
it will no longer be authorized to operate a retail drug store in the Commonwealth of 
Massachusetts and shall not in any way represent itself as a retail drug store or pharmacy until 
such time as the Board reinstates its pharmacy license or right to renew such license.  

11.	Village Fertility understands that it has a right to formal adjudicatory hearing concerning the 
Complaint and that during said adjudication it would possess the right to confront and cross-
examine witnesses, to call witnesses, to present evidence, to testify on its own behalf, to 
contest the allegations, to present oral argument, to appeal to the courts, and all other rights as 
set forth in the Massachusetts Administrative Procedures Act, M.G.L. c. 30A, and the 
Standard Adjudicatory Rules of Practice and Procedure, 801 CMR 1.01 et seq. The Licensee 
further understands that by executing this Agreement it is knowingly and voluntarily waiving 
its right to a formal adjudication of the Complaints.

12.	The Licensee acknowledges that it has been represented by legal counsel in connection with 
the Complaint and this Agreement.  

13.	The Licensee acknowledges that after the Effective Date, the Agreement constitutes a public 
record of disciplinary action by the Board.  The Board may forward a copy of this Agreement 
to other licensing boards, law enforcement entities, and other individuals or entities as required 
or permitted by law.

14.	The Licensee certifies that it has read this Agreement.  The Licensee understands and agrees 
that entering into this Agreement is a voluntary and final act and not subject to 
reconsideration, appeal or judicial review.

									Stuart Levine, 8/12/13  
									Village Fertility 

									Margaret Cittadino
									Associate Director
									Board of Registration in Pharmacy

									8/19/13 
									Effective Date of Probation Agreement

Fully Signed Agreement Sent to Licensee on by Certified 
Mail No. 7012 3460 0001 7330 9743