COMMONWEALTH OF MASSACHUSETTS

SUFFOLK COUNTY	                                                           BOARD OF REGISTRATION
                                                                                               IN PHARMACY

In the Matter of	            )
Aucella Drug	                        )                                              Docket No. PHA-2014-0190
Registration No. DS1213	)
Expiration: 12/31/2015	)

CONSENT AGREEMENT FOR
SUSPENSION FOLLOWED BY PROBATION

The Massachusetts Board of Registration in Pharmacy ("Board") and Aucella Drug ("Pharmacy" or "Licensee"), Registration No. DS1213, do hereby stipulate and agree that the following information shall be entered into and become a permanent part of the Pharmacy's record maintained by the Board:

1.	The Pharmacy acknowledges that a complaint has been opened by the Board against its Massachusetts pharmacy registration related to the conduct set forth in Paragraph 2, identified as Docket No. PHA-2014-0190 ("Complaint").

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

a.	On or about July 11, 2014, Investigators from Office of Public Protection
      ("Investigators"), on behalf of the  Board,  conducted an unannounced Retail
      Compliance Inspection ("Inspection") of Aucella Drug, located at 705 Salem
      Street in Malden, MA.

b.	Specifically, during the Inspection, the Investigators observed the following
      conditions:

i.   Failure to maintain clean and sanitary conditions m Pharmacy, in
     violation of 247 CMR 6.02(1);

                       ii.  Expired medications in inventory, including at least one medication that
                             expired in 2007, in violation of 247 CMR 9.01(10);

          iii.  Failure to maintain suitable sink with running hot water, in violation of
      247 CMR 6.01(5)(a)(7);

                      iv.  Illegible handwritten labels on prescriptions dispensed to patients, in
                            violation of M.G.L. c. 94C, § 21;

                       v.  Failure to properly store medications in a refrigerator that complies with
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1 The term “registration” applies to both a current registration and the right to renew an expired registration.

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                                 Board Policy No. 2011-11, in violation of 247 CMR 6.02(6). 
         
                     vi.  Failure to maintain proper security of controlled substances, including
                           door open to street and inside back door left unlocked, in violation of 247
                           CMR 6.02(6)(f);

                    vii.  Failure to maintain proper and secure storage of controlled substances, by
                           storing controlled substances indates together with controlled substances
                           outdates in a file cabinet, in violation of 247 CMR 6.02(6)(c);

                   viii.  Failure to store records in a manner as to maintain patient confidentiality
                           at all times, in violation of 247 CMR 9.01(19);

                     ix.  Failure to locate Oxycodone 10 mg stock bottle that was recorded in
                           perpetual inventory, in violation of 247 CMR 9.01(14);

                      x.  At least one attempt by Licensee to dispense prescription of Citalopram
                           from expired stock witnessed (and stopped) by Investigators, in violation
                           of 247 CMR 9.01(10);

                     xi.  Failure to properly file and maintain retrievable records, in violation of
                           247 CMR 9.01(14) and 247 CMR 9.05(1)-(3);

                    xii.  Failure to properly document information on DEA 222 forms, in violation
                           of 247 CMR 9.01(1);

xiii.  Failure to comply with the appropriate standards of non­ sterile
        compounding, in violation of 247 CMR 9.01(3);

                   xiv.  Failure to maintain readily retrievable records so as to conduct prospective
                           drug utilization review ("DUR") before each new prescription is dispensed
                           or delivered, in violation of 247 CMR 9.07(1)(a) and (2)(a);

xv.   Inaccessibility of Continuous Quality Improvement ("CQI") Program to
        pharmacy personnel so as to monitor compliance, collect data, analyze     
        findings, and provide ongoing education, in violation of 247 CMR
        5.04(1) and 247 CMR 15.02(1)(a) and (1)(d)-(f);

                  xvi.   Failure to maintain QRE records, in violation of 247 CMR 15.04(2);

                 xvii.   Failure to maintain a current copy or electronic version of the
                           Massachusetts List of Interchangeable Drugs ("MLID"), including the
                           Orange Book, Additional List, and Exception List, in violation of247 CMR
                           6.01(5)(a)(1);

                xviii.   Failure to maintain a current copy or electronic version of a compendia 
		    appropriate to the practice setting with quarterly updates, in violation of 
                                247 CMR 6.01(a)(2).          

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3.	The Licensee agrees the conditions described in Paragraph 2 constitute violations of M.G.L. c. 94C, 247 CMR 6.00, 247 CMR 9.00, and 247 CMR 15.00 and warrant disciplinary action by the Board under M.G.L. c. 112, §§ 42A & 61 and 247 CMR 10.03(1)(a), (e), (v), & (x).

4.	The Pharmacy agrees to SUSPENSION of its registration for no less than one (1) day ("Suspension Period"), commencing with the date on which the Board signs this Agreement ("Effective Date").

5.	After the Suspension Period, the Pharmacy agrees that its registration shall be placed 
            on PROBATION  for five (5) years ("Probationary Period").

6.	During the Probationary Period, the Pharmacy further agrees that it shall comply
            with the following requirements to the Board's satisfaction:

a.   Comply in all material respects with all laws and regulations governing the
      practice of pharmacy and the United States Pharmacopeia.

b.	Notify the Board in writing within ten (10) days of each change in its name
      and/or address.

c.   Timely renew its registration.

d.   Refrain from preparing and/or dispensing any sterile compounded medication
      unless and until it receives written approval from the Board to commence the
      preparation and dispensing of sterile compounded medications.

e.   Refrain from preparing and/or dispensing any non-sterile compounded
      medication unless and until it receives written approval from the Board to
      resume the preparation and dispensing of non-sterile compounded medications.

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

8.	If the Pharmacy has complied to the Board's satisfaction with all the requirements contained in this Agreement, the Probationary Period will terminate five (5) years after the Effective Date upon written notice to the Pharmacy from the Board.2

9.	If the Pharmacy does not materially comply with each requirement of this 

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2 In all instances where this Agreement specifies written notice to the Pharmacy from the Board, such notice shall be sent to the Pharmacy's address of record.

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            Agreement, or if the Board opens a Subsequent Complaint3 during the Suspension Period or the Probationary 
            Period, the Pharmacy agrees to the following:

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

	      i.   EXTEND the Suspension Period and/or the Probationary Period; and/or

ii.    MODIFY the Suspension Period and/or Probation Period requirements;
       and/or

                iii.   IMMEDIATELY SUSPEND the Pharmacy's license.

b.   If the Board suspends the Pharmacy's registration pursuant to Paragraph 9(a)(iii),
      the suspension shall remain in effect until:

                 i.   the Board provides the Pharmacy written notice that the Probationary Period
                      is to resume and under what terms; or

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

11.	The Pharmacy 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 Pharmacy further understands that by executing this Agreement it is knowingly and   voluntarily waiving its right to a formal adjudication of the Complaint.
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3 The term "Subsequent Complaint" applies to a complaint opened after the Effective Date concerning acts, omissions, or events occurring after the Effective Date, which (1) alleges that the Pharmacy engaged in conduct that violates Board statutes or regulations, and (2) is substantiated by evidence, as determined following the complaint investigation during which the Pharmacy shall have an opportunity to respond.

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12.	The Pharmacy acknowledges that it has been at all times free to seek and use legal counsel in connection with the Complaint and this Agreement.
13.	The Pharmacy	acknowledges	that after the Effective Date, the Agreement constitutes a public record pursuant to Commonwealth of Massachusetts' Public Records Law, M.G.L. c. 4, § 7(26), 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 individual signing this Agreement certifies that he/she is authorized to enter into this Agreement on behalf of the Pharmacy, and that he/she has read this Agreement.

15.	The Pharmacy agrees that entering into this Agreement is a voluntary and final act and not subject to reconsideration,  appeal or judicial review.

Frank A. Fritz for Aucella Drug, 4/5/15
							(sign and date)

David Sencabaugh, R.Ph., 4/30/15
Executive Director
Board of Registration in Pharmacy, 

Effective Date of Consent Agreement for Suspension followed by Probation: 4/30/15

Fully Signed Agreement Sent to Registrant on 4/15/15 by 
Certified Mail No. 7012  3460  0002  3702  9198

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