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        PRIOR PRINTER'S NO. 1538                      PRINTER'S NO. 2227

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

No. 1250 Session of 2007


        INTRODUCED BY KULA, EACHUS, KORTZ, SOLOBAY, MAHONEY, JOSEPHS,
           TANGRETTI, WALKO, FREEMAN, PRESTON, MOUL, SAYLOR, EVERETT,
           WATSON, GIBBONS, DALEY, SIPTROTH, HORNAMAN, FABRIZIO, JAMES
           AND PASHINSKI, MAY 8, 2007

        AS AMENDED, COMMITTEE ON PROFESSIONAL LICENSURE, HOUSE OF
           REPRESENTATIVES, JUNE 27, 2007

                                     AN ACT

     1  Amending the act of September 27, 1961 (P.L.1700, No.699),        <--
     2     entitled "An act relating to the regulation of the practice
     3     of pharmacy, including the sales, use and distribution of
     4     drugs and devices at retail; and amending, revising,
     5     consolidating and repealing certain laws relating thereto,"
     6     further providing for drug therapy protocols.
     7  AMENDING THE ACT OF SEPTEMBER 27, 1961 (P.L.1700, NO.699),        <--
     8     ENTITLED "AN ACT RELATING TO THE REGULATION OF THE PRACTICE
     9     OF PHARMACY, INCLUDING THE SALES, USE AND DISTRIBUTION OF
    10     DRUGS AND DEVICES AT RETAIL; AND AMENDING, REVISING,
    11     CONSOLIDATING AND REPEALING CERTAIN LAWS RELATING THERETO,"
    12     FURTHER PROVIDING FOR DEFINITIONS; PROVIDING FOR REGISTRATION
    13     AND PERMITS FOR PHARMACY TECHNICIANS; AND FURTHER PROVIDING
    14     FOR MULTIPLE LICENSURE, FOR REFUSAL TO GRANT REVOCATION AND
    15     SUSPENSION, FOR STATE BOARD OF PHARMACY, FOR HEARINGS AND
    16     SUSPENSIONS, FOR REINSTATEMENT, FOR DRUG THERAPY PROTOCOLS
    17     AND FOR PENALTIES.

    18     The General Assembly of the Commonwealth of Pennsylvania
    19  hereby enacts as follows:
    20     Section 1.  Section 9.1(a) of the act of September 27, 1961    <--
    21  (P.L.1700, No.699), known as the Pharmacy Act, added June 29,
    22  2002 (P.L.673, No.102), is amended to read:
    23     Section 9.1.  Drug Therapy Protocols.--(a)  A pharmacist
    24  shall be permitted to enter into a written agreement or protocol

     1  with a licensed physician authorizing the management of drug
     2  therapy in an institutional setting. For purposes of this
     3  section, an institutional setting shall include an integrated
     4  health setting such as academic health centers and group
     5  practice settings where the pharmacist is an integral member of
     6  the interdisciplinary clinical team and has access to the
     7  patient's medical record.
     8     * * *
     9     Section 2.  The State Board of Pharmacy shall promulgate
    10  regulations to implement the amendment of section 9.1(a) of the
    11  act within 18 months of the effective date of this section.
    12     Section 3.  This act shall take effect in 60 days.
    13     SECTION 1.  SECTION 2(11) AND (14) OF THE ACT OF SEPTEMBER     <--
    14  27, 1961 (P.L.1700, NO.699), KNOWN AS THE PHARMACY ACT, AMENDED
    15  OR ADDED JUNE 29, 2002 (P.L.673, NO.102), ARE AMENDED AND THE
    16  SECTION IS AMENDED BY ADDING PARAGRAPHS TO READ:
    17     SECTION 2.  DEFINITIONS.--AS USED IN THIS ACT:
    18     * * *
    19     (10.1)  "PHARMACY TECHNICIAN" MEANS AN INDIVIDUAL WHO IS
    20  REGISTERED BY THE STATE BOARD OF PHARMACY UNDER SECTION 2.1 TO
    21  ASSIST IN THE PRACTICE OF PHARMACY.
    22     (10.2)  "PHARMACY TECHNICIAN TRAINEE" MEANS AN INDIVIDUAL WHO
    23  HOLDS A TEMPORARY PERMIT ISSUED BY THE STATE BOARD OF PHARMACY
    24  UNDER SECTION 2.1.
    25     (10.3)  "DIRECT, IMMEDIATE AND PERSONAL SUPERVISION OF A
    26  PHARMACIST" MEANS:
    27     (I)  REVIEW BY THE PHARMACIST OF THE PRESCRIPTION OR DRUG
    28  ORDER PRIOR TO DISPENSING;
    29     (II)  VERIFICATION BY THE PHARMACIST OF THE FINAL PRODUCT;
    30  AND
    20070H1250B2227                  - 2 -     

     1     (III)  THE PHARMACIST'S IMMEDIATE AVAILABILITY ON THE
     2  PREMISES TO DIRECT THE WORK OF THE SUPERVISED INDIVIDUAL AND TO
     3  RESPOND TO QUESTIONS OR PROBLEMS.
     4     (11)  "PRACTICE OF PHARMACY" MEANS THE PROVISION OF HEALTH
     5  CARE SERVICES BY A PHARMACIST, WHICH INCLUDES THE
     6  INTERPRETATION, EVALUATION AND IMPLEMENTATION OF MEDICAL ORDERS
     7  FOR THE PROVISION OF PHARMACY SERVICES OR PRESCRIPTION DRUG
     8  ORDERS; THE DELIVERY, DISPENSING OR DISTRIBUTION OF PRESCRIPTION
     9  DRUGS; PARTICIPATION IN DRUG AND DEVICE SELECTION; DRUG
    10  ADMINISTRATION; DRUG REGIMEN REVIEW; MEDICATION THERAPY
    11  MANAGEMENT, INCLUDING SUCH SERVICES PROVIDED UNDER THE MEDICARE
    12  PRESCRIPTION DRUG IMPROVEMENT AND MODERNIZATION ACT OF 2003;
    13  DRUG OR DRUG-RELATED RESEARCH; COMPOUNDING; PROPER AND SAFE
    14  STORAGE OF DRUGS AND DEVICES; MANAGING DRUG THERAPY [IN AN
    15  INSTITUTIONAL SETTING CONSISTENT WITH THE INSTITUTION'S
    16  ASSIGNMENT OF CLINICAL DUTIES] PURSUANT TO A WRITTEN AGREEMENT
    17  OF PROTOCOL AS SET FORTH IN SECTION 9.1; MAINTAINING PROPER
    18  RECORDS; PATIENT COUNSELING; AND SUCH ACTS, SERVICES, OPERATIONS
    19  OR TRANSACTIONS NECESSARY OR INCIDENT TO THE PROVISION OF THESE
    20  HEALTH CARE SERVICES. THE "PRACTICE OF PHARMACY" SHALL NOT
    21  INCLUDE THE OPERATIONS OF A MANUFACTURER OR DISTRIBUTOR AS
    22  DEFINED IN "THE CONTROLLED SUBSTANCE, DRUG, DEVICE AND COSMETIC
    23  ACT."
    24     * * *
    25     (14)  "MANAGING DRUG THERAPY" MEANS ANY OF THE FOLLOWING
    26  PROCESSES WHICH SHALL BE PERFORMED [IN AN INSTITUTIONAL SETTING
    27  ONLY] PURSUANT TO A WRITTEN AGREEMENT OR PROTOCOL AS SET FORTH
    28  IN SECTION 9.1: ADJUSTING A DRUG REGIMEN; ADJUSTING DRUG
    29  STRENGTH, FREQUENCY OF ADMINISTRATION OR ROUTE; ADMINISTRATION
    30  OF DRUGS; AND ORDERING LABORATORY TESTS AND ORDERING AND
    20070H1250B2227                  - 3 -     

     1  PERFORMING OTHER DIAGNOSTIC TESTS NECESSARY IN THE MANAGEMENT OF
     2  DRUG [THERAPY, CONSISTENT WITH THE TESTING STANDARDS OF THE
     3  INSTITUTION. MANAGING DRUG THERAPY SHALL BE PERFORMED PURSUANT
     4  TO A WRITTEN AGREEMENT OR PROTOCOL AS SET FORTH IN SECTION 9.1
     5  OF THIS ACT.] THERAPY. MANAGING DRUG THERAPY IN AN INSTITUTIONAL
     6  SETTING SHALL BE PERFORMED CONSISTENT WITH THE INSTITUTION'S
     7  ASSIGNMENT OF CLINICAL DUTIES AND ORDERING OF LABORATORY TESTS
     8  AND ORDERING OR PERFORMING OTHER DIAGNOSTIC TESTS NECESSARY IN
     9  THE MANAGEMENT OF DRUG THERAPY SHALL BE CONSISTENT WITH THE
    10  TESTING STANDARDS OF THE INSTITUTION.
    11     * * *
    12     (15.1)  "NON-INSTITUTIONAL SETTING" MEANS A LICENSED PHARMACY
    13  OTHER THAN ONE LOCATED IN AN INSTITUTION THAT EMPLOYS ONE OR
    14  MORE LICENSED PHARMACISTS THAT MAY CONTRACT THROUGH THAT
    15  PHARMACY TO MANAGE DRUG THERAPY UNDER A WRITTEN AGREEMENT WITH A
    16  PHYSICIAN.
    17     SECTION 2.  THE ACT IS AMENDED BY ADDING A SECTION TO READ:
    18     SECTION 2.1.  REGISTRATION AND PERMITS FOR PHARMACY
    19  TECHNICIANS.--(A)  THE BOARD MAY REGISTER AS A PHARMACY
    20  TECHNICIAN ANY INDIVIDUAL WHO DOES THE FOLLOWING:
    21     (1)  PAYS AN APPLICATION FEE PRESCRIBED BY THE DEPARTMENT.
    22     (2)  FILES AN APPLICATION FOR LICENSURE, SUBSCRIBED BY THE
    23  INDIVIDUAL UNDER OATH OR AFFIRMATION, CONTAINING INFORMATION THE
    24  BOARD REQUIRES.
    25     (3)  EXCEPT AS SET FORTH IN SUBSECTION (B), COMPLIES WITH ALL
    26  OF THE FOLLOWING:
    27     (I)  IS NOT LESS THAN EIGHTEEN YEARS OF AGE AND IS A CITIZEN
    28  OF THE UNITED STATES.
    29     (II)  HAS A HIGH SCHOOL DIPLOMA OR ITS EQUIVALENT.
    30     (III)  HAS SATISFIED THE BOARD THAT THE APPLICANT IS OF GOOD
    20070H1250B2227                  - 4 -     

     1  MORAL CHARACTER AND IS NOT UNFIT OR UNABLE TO PRACTICE AS A
     2  PHARMACY TECHNICIAN BY REASON OF THE EXTENT OR MANNER OF HIS USE
     3  OF ALCOHOLIC BEVERAGES OR CONTROLLED SUBSTANCES OR BY REASON OF
     4  A PHYSICAL OR MENTAL DISABILITY.
     5     (IV)  HAS COMPLETED A PHARMACY TECHNICIAN TRAINING PROGRAM
     6  APPROVED BY THE BOARD.
     7     (V)  HAS RECEIVED CERTIFICATION FROM A CERTIFYING AGENCY
     8  APPROVED BY A NATIONALLY RECOGNIZED ACCREDITING AGENCY APPROVED
     9  BY THE BOARD; OR HAS SUCCESSFULLY COMPLETED AN EXAMINATION
    10  APPROVED BY THE BOARD.
    11     (VI)  EXAMINATIONS SHALL BE ADMINISTERED IN ACCORDANCE WITH
    12  THE REQUIREMENTS SET FORTH IN SECTION 812.1(A) OF THE ACT OF
    13  APRIL 9, 1929 (P.L.177, NO.175), KNOWN AS "THE ADMINISTRATIVE
    14  CODE OF 1929."
    15     (VII)  HAS NOT BEEN CONVICTED OF A FELONIOUS ACT PROHIBITED
    16  BY THE ACT OF APRIL 14, 1972 (P.L.233, NO.64), KNOWN AS "THE
    17  CONTROLLED SUBSTANCE, DRUG, DEVICE AND COSMETIC ACT," OR
    18  CONVICTED OF A FELONY RELATING TO A CONTROLLED SUBSTANCE IN A
    19  COURT OF LAW OF THE UNITED STATES OR ANY OTHER STATE, TERRITORY
    20  OR COUNTRY UNLESS:
    21     (A)  AT LEAST TEN YEARS HAVE ELAPSED FROM THE DATE OF
    22  CONVICTION; AND
    23     (B)  THE APPLICANT SATISFACTORILY DEMONSTRATES TO THE BOARD
    24  THAT THE APPLICANT HAS MADE SIGNIFICANT PROGRESS IN PERSONAL
    25  REHABILITATION SINCE THE CONVICTION SUCH THAT LICENSURE OF THE
    26  APPLICANT SHOULD NOT BE EXPECTED TO CREATE A SUBSTANTIAL RISK OF
    27  HARM TO THE HEALTH AND SAFETY OF PATIENTS OR THE PUBLIC OR A
    28  SUBSTANTIAL RISK OF FURTHER CRIMINAL VIOLATIONS. AS USED IN THIS
    29  CLAUSE, THE TERM "CONVICTED" SHALL INCLUDE A JUDGMENT, AN
    30  ADMISSION OF GUILT OR A PLEA OF NOLO CONTENDERE. AN APPLICANT'S
    20070H1250B2227                  - 5 -     

     1  STATEMENT ON THE APPLICATION DECLARING THE ABSENCE OF A
     2  CONVICTION SHALL BE DEEMED SATISFACTORY EVIDENCE OF THE ABSENCE
     3  OF A CONVICTION, UNLESS THE BOARD HAS SOME EVIDENCE TO THE
     4  CONTRARY.
     5     (B)  THE FOLLOWING APPLY:
     6     (1)  NOTWITHSTANDING SUBSECTION (A)(3)(IV) AND (V), THE BOARD
     7  SHALL REGISTER ALL OF THE FOLLOWING:
     8     (I)  AN INDIVIDUAL WHO, AT THE TIME OF FILING AN APPLICATION,
     9  HAS PROOF OR REGISTRATION, CERTIFICATION OR LICENSURE OR ITS
    10  EQUIVALENT AS A PHARMACY TECHNICIAN IN ANOTHER STATE, TERRITORY
    11  OR POSSESSION OF THE UNITED STATES WHICH HAS REGISTRATION,
    12  CERTIFICATION, LICENSURE OR EQUIVALENT REQUIREMENTS COMPARABLE
    13  TO THOSE SET FORTH IN THIS SECTION AND REGULATIONS OF THE BOARD.
    14     (II)  AN INDIVIDUAL WHO:
    15     (A)  APPLIES FOR REGISTRATION WITHIN TWO YEARS AFTER THE
    16  EFFECTIVE DATE OF THIS SECTION; AND
    17     (B)  ON THE EFFECTIVE DATE OF THIS SECTION MAINTAINS A
    18  CURRENT CERTIFICATION BY A NATIONALLY RECOGNIZED PHARMACY
    19  TECHNICIAN ASSOCIATION.
    20     (2)  NOTWITHSTANDING SUBSECTION (A)(3)(II), (IV) AND (V), THE
    21  BOARD SHALL ISSUE A LICENSE TO AN INDIVIDUAL WHO:
    22     (I)  HAS BEEN EMPLOYED AS A PHARMACY TECHNICIAN FOR A MINIMUM
    23  OF 2,000 HOURS DURING THE THREE YEARS IMMEDIATELY PRECEDING THE
    24  ENACTMENT OF THIS ACT.
    25     (II)  DEMONSTRATES TO THE SATISFACTION OF THE BOARD PROOF OF
    26  PRACTICE AS A PHARMACY TECHNICIAN FOR AT LEAST TWO THOUSAND
    27  HOURS IMMEDIATELY PRIOR TO THE DATE OF APPLICATION.
    28     (C)  A REGISTRATION SHALL AUTHORIZE THE REGISTRANT TO ASSIST
    29  IN THE PRACTICE OF PHARMACY UNDER THE DIRECT, IMMEDIATE AND
    30  PERSONAL SUPERVISION OF A PHARMACIST.
    20070H1250B2227                  - 6 -     

     1     (D)  A REGISTRATION IS SUBJECT TO BIENNIAL RENEWAL. THE BOARD
     2  SHALL ESTABLISH A FEE FOR RENEWAL BY REGULATION.
     3     (E)  THE FOLLOWING APPLY TO PHARMACY TECHNICIAN TRAINEES:
     4     (1)  THE BOARD SHALL ISSUE A TEMPORARY PERMIT TO PRACTICE AS
     5  A PHARMACY TECHNICIAN TRAINEE TO AN APPLICANT WHO IS SEVENTEEN
     6  YEARS OF AGE OR OLDER AND MEETS THE REQUIREMENTS OF SUBSECTION
     7  (A)(3)(II) AND (VI) AND COMPLIES WITH THE FOLLOWING:
     8     (I)  THE INDIVIDUAL IS A STUDENT ENROLLED IN A BOARD-APPROVED
     9  PHARMACY TECHNICIAN TRAINING PROGRAM AND AS PART OF THE PROGRAM
    10  MAY BE REQUIRED TO SERVE AN EXTERNSHIP OR INTERNSHIP; OR
    11     (II)  THE INDIVIDUAL IS EMPLOYED BY A PHARMACY AND
    12  PARTICIPATES IN A BOARD-APPROVED PHARMACY TECHNICIAN TRAINING
    13  PROGRAM WHICH MAY INCLUDE AN EXTERNSHIP OR INTERNSHIP PROGRAM.
    14     (2)  A TEMPORARY PRACTICE PERMIT SHALL BE ISSUED FOR ONE YEAR
    15  AND MAY BE EXTENDED FOR A SINGLE SIX-MONTH PERIOD UPON
    16  VERIFICATION TO THE SATISFACTION OF THE BOARD THAT THE TRAINEE
    17  HAS COMPLETED THE BOARD-APPROVED TRAINING PROGRAM.
    18     (3)  A TEMPORARY PERMIT SHALL NOT BE REISSUED.
    19     (4)  A TEMPORARY PERMIT SHALL AUTHORIZE THE PERMITTEE TO
    20  PERFORM THE DUTIES OF A PHARMACY TECHNICIAN UNDER THE DIRECT,
    21  IMMEDIATE AND PERSONAL SUPERVISION OF A PHARMACIST.
    22     (F)  IDENTIFICATION REQUIREMENTS ARE AS FOLLOWS:
    23     (1)  A PHARMACY TECHNICIAN SHALL WEAR A NAME TAG THAT CLEARLY
    24  IDENTIFIES THE PHARMACY TECHNICIAN WITH THE TITLE "LICENSED
    25  PHARMACY TECHNICIAN."
    26     (2)  A HOLDER OF A TEMPORARY PERMIT SHALL WEAR A NAME TAG
    27  THAT CLEARLY IDENTIFIES THE TEMPORARY PERMIT HOLDER WITH THE
    28  TITLE "PHARMACY TECHNICIAN TRAINEE."
    29     (G)  THIS SECTION SHALL NOT APPLY TO ANY STUDENT WHO IS
    30  ENROLLED IN AN ACCREDITED SCHOOL OF PHARMACY AND WHO IS IN GOOD
    20070H1250B2227                  - 7 -     

     1  STANDING.
     2     SECTION 3.  SECTION 3.2 OF THE ACT, ADDED DECEMBER 20, 1985
     3  (P.L.433, NO.111), IS AMENDED TO READ:
     4     SECTION 3.2.  REPORTING OF MULTIPLE LICENSURE.--ANY
     5  [LICENSED] PHARMACIST OR PHARMACY TECHNICIAN OF THIS
     6  COMMONWEALTH WHO IS ALSO REGISTERED, CERTIFIED OR LICENSED [TO
     7  PRACTICE PHARMACY] IN ANY OTHER STATE, TERRITORY OR COUNTRY
     8  SHALL REPORT THIS INFORMATION TO THE BOARD ON THE BIENNIAL
     9  REGISTRATION APPLICATION. ANY DISCIPLINARY ACTION TAKEN IN OTHER
    10  STATES, TERRITORIES AND COUNTRIES SHALL BE REPORTED TO THE BOARD
    11  ON THE BIENNIAL REGISTRATION APPLICATION OR WITHIN NINETY DAYS
    12  OF FINAL DISPOSITION, WHICHEVER IS SOONER. MULTIPLE [LICENSURE]
    13  REGISTRATION CERTIFICATION OR LICENSURE SHALL BE NOTED BY THE
    14  BOARD ON THE [PHARMACIST'S] REGISTRANT'S RECORD, AND SUCH STATE,
    15  TERRITORY OR COUNTRY SHALL BE NOTIFIED BY THE BOARD OF ANY
    16  DISCIPLINARY ACTIONS TAKEN AGAINST [SAID PHARMACIST] THAT
    17  LICENSEE IN THIS COMMONWEALTH.
    18     SECTION 4.  SECTION 5(A)(9) AND (C) OF THE ACT, AMENDED
    19  DECEMBER 20, 1985 (P.L.433, NO.111), ARE AMENDED AND THE SECTION
    20  IS AMENDED BY ADDING A SUBSECTION TO READ:
    21     SECTION 5.  REFUSAL TO GRANT, REVOCATION AND SUSPENSION.--(A)
    22  THE BOARD SHALL HAVE THE POWER TO REFUSE, REVOKE OR SUSPEND THE
    23  LICENSE OF ANY PHARMACIST UPON PROOF SATISFACTORY TO IT THAT THE
    24  PHARMACIST:
    25     * * *
    26     (9)  IS GUILTY OF GROSSLY UNPROFESSIONAL CONDUCT. THE
    27  FOLLOWING ACTS ON THE PART OF A PHARMACIST ARE HEREBY DECLARED
    28  TO CONSTITUTE GROSSLY UNPROFESSIONAL CONDUCT OF A PHARMACIST:
    29     (I)  WILLFULLY DECEIVING OR ATTEMPTING TO DECEIVE THE STATE
    30  BOARD OF PHARMACY OR ITS AGENTS WITH RESPECT TO ANY MATERIAL
    20070H1250B2227                  - 8 -     

     1  MATTER UNDER INVESTIGATION BY THE BOARD;
     2     (II)  ADVERTISING OF PRICES FOR DRUGS AND PHARMACEUTICAL
     3  SERVICES TO THE PUBLIC WHICH DOES NOT CONFORM TO FEDERAL LAWS OR
     4  REGULATIONS;
     5     (III)  THE PUBLIC ASSERTION OR IMPLICATION OF PROFESSIONAL
     6  SUPERIORITY IN THE PRACTICE OF PHARMACY;
     7     (IV)  THE ENGAGING BY ANY MEANS IN UNTRUE, FALSE, MISLEADING
     8  OR DECEPTIVE ADVERTISING OF DRUGS OR DEVICES;
     9     (V)  PAYING REBATES TO PHYSICIANS OR ANY OTHER PERSONS, OR
    10  THE ENTERING INTO ANY AGREEMENT WITH A MEDICAL PRACTITIONER OR
    11  ANY OTHER PERSON FOR THE PAYMENT OR ACCEPTANCE OF COMPENSATION
    12  IN ANY FORM FOR THE RECOMMENDING OF THE PROFESSIONAL SERVICES OF
    13  EITHER PARTY;
    14     (VI)  THE ENTERING INTO OF ANY AGREEMENT WITH A LICENSED
    15  MEDICAL PRACTITIONER FOR THE COMPOUNDING OR DISPENSING OF SECRET
    16  FORMULA (CODED), PRESCRIPTIONS;
    17     (VII)  THE MISBRANDING OR ADULTERATION OF ANY DRUG OR DEVICE
    18  AND THE SALE, DISTRIBUTION OR DISPENSING OF ANY MISBRANDED OR
    19  ADULTERATED DRUG OR DEVICE AS DEFINED IN THE ACT OF APRIL 14,
    20  1972 (P.L.233, NO.64), KNOWN AS "THE CONTROLLED SUBSTANCE, DRUG,
    21  DEVICE AND COSMETIC ACT";
    22     (VIII)  ENGAGING IN THE SALE OR PURCHASE OF DRUGS OR DEVICES
    23  WHOSE PACKAGE BEARS THE INSCRIPTION "SAMPLE" OR "NOT FOR
    24  RESALE;"
    25     (IX)  DISPLAYING OR PERMITTING THE DISPLAY OF HIS CERTIFICATE
    26  OF LICENSURE AND BIENNIAL REGISTRATION DOCUMENT IN A PHARMACY OF
    27  WHICH HE IS NOT THE PROPRIETOR OR IN WHICH HE IS NOT EMPLOYED;
    28     (X)  ANY HOLDER OF A BIENNIAL POCKET REGISTRATION CARD WHO
    29  FAILS TO HAVE THE CARD AVAILABLE FOR INSPECTION BY AN AUTHORIZED
    30  AGENT WHEN HE IS PRACTICING;
    20070H1250B2227                  - 9 -     

     1     (XI)  THE ACCEPTANCE BACK AND REDISTRIBUTION OF ANY UNUSED
     2  DRUG, OR A PART THEREOF, AFTER IT HAS LEFT THE PREMISES OF ANY
     3  PHARMACY, WHETHER ISSUED BY MISTAKE OR OTHERWISE, UNLESS IT IS
     4  IN THE ORIGINAL SEALED CONTAINER WITH THE NAME, LOT NUMBER AND
     5  EXPIRATION DATE ON THE ORIGINAL INTACT MANUFACTURER'S LABEL. THE
     6  PHARMACY SHALL MAINTAIN RECORDS OF ALL SUCH RETURNS, AND A FULL
     7  REFUND SHALL BE GIVEN TO THE ORIGINAL PURCHASER, INCLUDING A
     8  THIRD-PARTY PAYOR;
     9     [(XII)  TO ACCEPT EMPLOYMENT AS A PHARMACIST, OR SHARE OR
    10  RECEIVE COMPENSATION IN ANY FORM ARISING OUT OF, OR INCIDENTAL
    11  TO, HIS PROFESSIONAL ACTIVITIES FROM ANY MEDICAL PRACTITIONER OR
    12  ANY OTHER PERSON OR CORPORATION IN WHICH ONE OR MORE MEDICAL
    13  PRACTITIONERS HAVE A PROPRIETARY OR BENEFICIAL INTEREST
    14  SUFFICIENT TO PERMIT THEM TO EXERCISE SUPERVISION OR CONTROL
    15  OVER THE PHARMACIST IN HIS PROFESSIONAL RESPONSIBILITIES AND
    16  DUTIES;
    17     (XIII)  TO ACCEPT EMPLOYMENT AS A PHARMACIST, OR SHARE OR
    18  RECEIVE COMPENSATION IN ANY FORM ARISING OUT OF, OR INCIDENTAL
    19  TO, HIS PROFESSIONAL ACTIVITIES FROM ANY PERSON WHO ORDERS SAID
    20  PHARMACIST, DIRECTLY OR INDIRECTLY, TO ENGAGE IN ANY ASPECT OF
    21  THE PRACTICE OF PHARMACY IN CONTRAVENTION OF ANY PROVISION OF
    22  THIS ACT.]
    23     (XII)  TO ACCEPT EMPLOYMENT AS A PHARMACIST FROM ANY HEALTH
    24  CARE PRACTITIONER, OTHER PERSON OR ENTITY, WHEREBY THE
    25  PHARMACIST ENGAGES IN ANY ASPECT OF THE PRACTICE OF PHARMACY IN
    26  CONTRAVENTION OF ANY PROVISION OF THIS ACT OR FEDERAL LAW.
    27     (XIII)  TO SHARE OR RECEIVE COMPENSATION IN ANY FORM ARISING
    28  OUT OF, OR INCIDENTAL TO, HIS PROFESSIONAL ACTIVITIES WHEREBY
    29  THE PHARMACIST ENGAGED IN ANY ASPECT OF THE PRACTICE OF PHARMACY
    30  IN CONTRAVENTION OF ANY PROVISION OF THIS ACT OR FEDERAL LAW.
    20070H1250B2227                 - 10 -     

     1     (XIV)  IT SHALL BE UNLAWFUL FOR A PHARMACIST OR PHARMACY
     2  PERMIT HOLDER TO ENTER INTO AN ARRANGEMENT WITH A HEALTH CARE
     3  PRACTITIONER WHO IS LICENSED TO ISSUE PRESCRIPTIONS FOR THE
     4  PURPOSE OF DIRECTING OR DIVERTING PATIENTS TO OR FROM A
     5  SPECIFIED PHARMACY OR RESTRAINING IN ANY WAY A PATIENT'S FREEDOM
     6  OF CHOICE TO SELECT A PHARMACY.
     7     (A.1)  THE BOARD SHALL HAVE THE POWER TO REFUSE, REVOKE OR
     8  SUSPEND THE REGISTRATION OF ANY PHARMACY TECHNICIAN UPON PROOF
     9  SATISFACTORY TO IT THAT THE PHARMACY TECHNICIAN HAS DONE ANY OF
    10  THE FOLLOWING:
    11     (1)  PROCURED A PERSON REGISTRATION THROUGH FRAUD,
    12  MISREPRESENTATION OR DECEIT.
    13     (2)  HAS BEEN FOUND GUILTY, PLEADED GUILTY, ENTERED A PLEA OF
    14  NOLO CONTENDERE, OR HAS RECEIVED PROBATION WITHOUT VERDICT,
    15  DISPOSITION IN LIEU OF TRIAL OR AN ACCELERATED REHABILITATIVE
    16  DISPOSITION IN THE DISPOSITION OF FELONY CHARGES, TO ANY OFFENSE
    17  IN CONNECTION WITH THE PRACTICE OF PHARMACY OR ANY OFFENSE
    18  INVOLVING MORAL TURPITUDE BEFORE ANY COURT OF RECORD OF ANY
    19  JURISDICTION.
    20     (3)  IS UNFIT TO PRACTICE AS A PHARMACY TECHNICIAN BECAUSE OF
    21  INTEMPERANCE IN THE USE OF ALCOHOLIC BEVERAGES, CONTROLLED
    22  SUBSTANCES OR ANY OTHER SUBSTANCE WHICH IMPAIRS THE INTELLECT
    23  AND JUDGMENT TO SUCH AN EXTENT AS TO IMPAIR THE PERFORMANCE OF
    24  PROFESSIONAL DUTIES.
    25     (4)  IS UNFIT OR UNABLE TO PRACTICE AS A PHARMACY TECHNICIAN
    26  BY REASON OF A PHYSICAL OR MENTAL DISEASE OR DISABILITY. IN
    27  ENFORCING THIS CLAUSE, THE BOARD SHALL, UPON PROBABLE CAUSE,
    28  HAVE AUTHORITY TO COMPEL A PHARMACY TECHNICIAN TO SUBMIT TO A
    29  MENTAL OR PHYSICAL EXAMINATION BY PHYSICIANS OR PSYCHOLOGISTS
    30  APPROVED BY THE BOARD. FAILURE OF A PHARMACY TECHNICIAN TO
    20070H1250B2227                 - 11 -     

     1  SUBMIT TO EXAMINATION WHEN DIRECTED BY THE BOARD, UNLESS DUE TO
     2  CIRCUMSTANCES BEYOND THE PHARMACY TECHNICIAN'S CONTROL, SHALL
     3  CONSTITUTE AN ADMISSION OF THE ALLEGATIONS AGAINST THE PHARMACY
     4  TECHNICIAN, CONSEQUENT UPON WHICH A DEFAULT AND FINAL ORDER MAY
     5  BE ENTERED WITHOUT THE TAKING OF TESTIMONY OR PRESENTATION OF
     6  EVIDENCE. A PHARMACY TECHNICIAN AFFECTED UNDER THIS CLAUSE SHALL
     7  AT REASONABLE INTERVALS BE AFFORDED AN OPPORTUNITY TO
     8  DEMONSTRATE THAT ABILITY TO RESUME A COMPETENT PRACTICE AS A
     9  PHARMACY TECHNICIAN WITH REASONABLE SKILL AND SAFETY TO
    10  PATIENTS.
    11     (5)  HAS HAD A REGISTRATION, CERTIFICATION OR LICENSE TO
    12  PRACTICE AS A PHARMACY TECHNICIAN DENIED, REVOKED OR SUSPENDED
    13  BY AN APPROPRIATE PHARMACY TECHNICIAN REGISTRATION,
    14  CERTIFICATION OR LICENSING AUTHORITY OR HAS RECEIVED
    15  DISCIPLINARY ACTION FROM AN APPROPRIATE PHARMACY TECHNICIAN
    16  REGISTRATION, CERTIFICATION OR LICENSING AUTHORITY.
    17     (6)  HAS ACTED IN SUCH A MANNER AS TO PRESENT AN IMMEDIATE
    18  AND CLEAR DANGER TO THE PUBLIC HEALTH OR SAFETY.
    19     (7)  IS GUILTY OF INCOMPETENCE, GROSS NEGLIGENCE OR OTHER
    20  MALPRACTICE, OR THE DEPARTURE FROM, OR FAILURE TO CONFORM TO,
    21  THE STANDARDS OF ACCEPTABLE AND PREVAILING PHARMACY TECHNICIAN
    22  PRACTICE, IN WHICH CASE ACTUAL INJURY NEED NOT BE ESTABLISHED.
    23     * * *
    24     (C)  WHEN THE BOARD FINDS THAT THE REGISTRATION,
    25  CERTIFICATION OR LICENSE [OF ANY PHARMACIST] MAY BE REFUSED,
    26  REVOKED OR SUSPENDED UNDER THE TERMS OF SUBSECTION (A) OR (A.1),
    27  THE BOARD MAY:
    28     (1)  DENY THE APPLICATION FOR A REGISTRATION, CERTIFICATION
    29  OR LICENSE.
    30     (2)  ADMINISTER A PUBLIC REPRIMAND.
    20070H1250B2227                 - 12 -     

     1     (3)  REVOKE, SUSPEND, LIMIT OR OTHERWISE RESTRICT A
     2  REGISTRATION, CERTIFICATION OR LICENSE AS DETERMINED BY THE
     3  BOARD.
     4     (4)  REQUIRE A LICENSEE TO SUBMIT TO THE CARE, COUNSELING OR
     5  TREATMENT OF A PHYSICIAN OR A PSYCHOLOGIST DESIGNATED BY THE
     6  BOARD. THIS CLAUSE DOES NOT APPLY TO A PHARMACY TECHNICIAN.
     7     (5)  SUSPEND ENFORCEMENT OF ITS FINDING THEREOF AND PLACE A
     8  LICENSEE ON PROBATION WITH THE RIGHT TO VACATE THE PROBATIONARY
     9  ORDER FOR NONCOMPLIANCE.
    10     (6)  RESTORE OR REISSUE, IN ITS DISCRETION, A SUSPENDED
    11  LICENSE [TO PRACTICE PHARMACY] OR REGISTRATION AND IMPOSE ANY
    12  DISCIPLINARY OR CORRECTIVE MEASURE WHICH IT MIGHT ORIGINALLY
    13  HAVE IMPOSED.
    14     * * *
    15     SECTION 5.  SECTION 6(K) OF THE ACT, AMENDED DECEMBER 20,
    16  1985 (P.L.433, NO.111), IS AMENDED TO READ:
    17     SECTION 6.  STATE BOARD OF PHARMACY.--* * *
    18     (K)  THE BOARD SHALL HAVE THE POWER, AND IT SHALL BE ITS
    19  DUTY:
    20     (1)  TO REGULATE THE PRACTICE OF PHARMACY AND OF PHARMACY
    21  TECHNICIANS;
    22     (2)  TO DETERMINE THE NATURE OF EXAMINATIONS FOR ALL
    23  APPLICANTS FOR [PHARMACISTS'] LICENSES;
    24     (3)  TO EXAMINE, INSPECT AND INVESTIGATE ALL APPLICATIONS AND
    25  ALL APPLICANTS FOR LICENSURE AS PHARMACISTS, PHARMACIES OR
    26  REGISTRATION AS PHARMACY INTERNS AND PHARMACY TECHNICIANS, AND
    27  TO GRANT CERTIFICATES OF LICENSURE OR REGISTRATION TO ALL
    28  APPLICANTS WHOM IT SHALL JUDGE TO BE PROPERLY QUALIFIED;
    29     (4)  WITH THE APPROVAL OF THE COMMISSIONER OF PROFESSIONAL
    30  AND OCCUPATIONAL AFFAIRS, TO PREPARE POSITION DESCRIPTIONS,
    20070H1250B2227                 - 13 -     

     1  EMPLOY INSPECTORS WHO SHALL BE LICENSED PHARMACISTS AND EMPLOY
     2  APPROPRIATE CONSULTANTS TO ASSIST IT FOR ANY PURPOSES WHICH IT
     3  MAY DEEM NECESSARY, PROVIDED THAT THE BOARD MAY NOT DELEGATE ANY
     4  OF ITS FINAL DECISIONMAKING RESPONSIBILITIES TO ANY CONSULTANT;
     5     (5)  TO INVESTIGATE OR CAUSE TO BE INVESTIGATED ALL
     6  VIOLATIONS OF THE PROVISIONS OF THIS ACT AND ITS REGULATIONS AND
     7  TO CAUSE PROSECUTIONS TO BE INSTITUTED IN THE COURTS UPON ADVICE
     8  FROM THE ATTORNEY GENERAL;
     9     (6)  TO MAKE OR ORDER INSPECTIONS OF ALL PHARMACIES, EXCEPT
    10  HEALTH CARE FACILITIES, AS DEFINED IN THE ACT OF JULY 19, 1979
    11  (P.L.130, NO.48), KNOWN AS THE "HEALTH CARE FACILITIES ACT," AND
    12  WHICH ARE PERIODICALLY INSPECTED BY THE DEPARTMENT OF HEALTH IN
    13  ACCORDANCE WITH THE STANDARDS IN THIS ACT AND THE BOARD'S
    14  REGULATIONS PROMULGATED THERETO: PROVIDED, THAT THE DEPARTMENT
    15  OF HEALTH SHALL FORWARD A COPY OF THEIR INSPECTION REPORT TO THE
    16  BOARD NOTING ANY VIOLATIONS OF THE ACT: AND, PROVIDED FURTHER,
    17  THAT, IF A VIOLATION IS REPORTED, THE BOARD SHALL HAVE THE POWER
    18  TO INSPECT SUCH PHARMACIES AND TAKE APPROPRIATE ACTION AS
    19  SPECIFIED IN THIS ACT; AND TO MAKE OR ORDER INSPECTIONS OF OTHER
    20  PLACES IN WHICH DRUGS OR DEVICES ARE STORED, HELD, COMPOUNDED,
    21  DISPENSED OR SOLD TO A CONSUMER, TO TAKE AND ANALYZE ANY DRUGS
    22  OR DEVICES AND TO SEIZE AND CONDEMN ANY DRUGS OR DEVICES WHICH
    23  ARE ADULTERATED, MISBRANDED OR STORED, HELD, DISPENSED,
    24  DISTRIBUTED OR COMPOUNDED IN VIOLATION OF THE PROVISIONS OF THIS
    25  ACT OR THE PROVISIONS OF THE ACT OF APRIL 14, 1972 (P.L.233,
    26  NO.64), KNOWN AS "THE CONTROLLED SUBSTANCE, DRUG, DEVICE AND
    27  COSMETIC ACT";
    28     (7)  TO CONDUCT HEARINGS FOR THE REVOCATION OR SUSPENSION OF
    29  LICENSES, PERMITS OR REGISTRATIONS, FOR WHICH HEARINGS THE BOARD
    30  SHALL HAVE THE POWER TO SUBPOENA WITNESSES;
    20070H1250B2227                 - 14 -     

     1     (8)  TO ASSIST THE REGULARLY CONSTITUTED ENFORCEMENT AGENCIES
     2  OF THIS COMMONWEALTH IN ENFORCING ALL LAWS PERTAINING TO DRUGS,
     3  CONTROLLED SUBSTANCES, AND PRACTICE OF PHARMACY;
     4     (8.1)  TO APPROVE PROGRAMS FOR THE TRAINING OF PHARMACY
     5  TECHNICIANS.
     6     (9)  TO PROMULGATE RULES AND REGULATIONS TO EFFECTUATE THE
     7  PURPOSES OF THIS ACT AND TO REGULATE THE DISTRIBUTION OF DRUGS
     8  AND DEVICES AND THE PRACTICE OF PHARMACY FOR THE PROTECTION AND
     9  PROMOTION OF THE PUBLIC HEALTH, SAFETY AND WELFARE.
    10     * * *
    11     SECTION 6.  SECTION 7 OF THE ACT IS AMENDED BY ADDING A
    12  SUBSECTION TO READ:
    13     SECTION 7.  HEARINGS AND SUSPENSIONS.--* * *
    14     (E)  NOTWITHSTANDING ANY OTHER PROVISION, SUBSECTIONS (D.3),
    15  (D.4), (D.5), (D.6), (D.7) AND (D.8) SHALL NOT APPLY TO PHARMACY
    16  TECHNICIANS.
    17     SECTION 7.  SECTIONS 7.1, 8(2) AND (8) AND 8.1 OF THE ACT,
    18  AMENDED OR ADDED DECEMBER 20, 1985 (P.L.433, NO.111), ARE
    19  AMENDED TO READ:
    20     SECTION 7.1.  REINSTATEMENT OF LICENSE, CERTIFICATE OR
    21  REGISTRATION.--UNLESS ORDERED TO DO SO BY COMMONWEALTH COURT OR
    22  AN APPEAL THEREFROM, THE BOARD SHALL NOT REINSTATE THE LICENSE,
    23  CERTIFICATE OR REGISTRATION OF A PERSON TO PRACTICE [PHARMACY]
    24  PURSUANT TO THIS ACT WHICH HAS BEEN REVOKED. ANY PERSON WHOSE
    25  LICENSE, CERTIFICATE OR REGISTRATION HAS BEEN REVOKED MAY APPLY
    26  FOR REINSTATEMENT, AFTER A PERIOD OF AT LEAST FIVE YEARS, BUT
    27  MUST MEET ALL OF THE LICENSING QUALIFICATIONS OF THIS ACT FOR
    28  THE LICENSE APPLIED FOR, TO INCLUDE THE EXAMINATION REQUIREMENT,
    29  IF HE OR SHE DESIRES TO PRACTICE AT ANY TIME AFTER SUCH
    30  REVOCATION.
    20070H1250B2227                 - 15 -     

     1     SECTION 8.  UNLAWFUL ACTS.--IT SHALL BE UNLAWFUL FOR:
     2     * * *
     3     (2)  ANY PERSON NOT DULY LICENSED AS A PHARMACIST, PURSUANT
     4  TO SECTION 3 HEREOF, TO ENGAGE IN THE PRACTICE OF PHARMACY,
     5  INCLUDING THE PREPARING, COMPOUNDING, DISPENSING, SELLING OR
     6  DISTRIBUTING AT RETAIL TO ANY PERSON ANY DRUG, EXCEPT BY A
     7  PHARMACY INTERN, PHARMACY TECHNICIAN OR SUCH OTHER AUTHORIZED
     8  PERSONNEL UNDER THE DIRECT AND IMMEDIATE PERSONAL SUPERVISION OF
     9  A PHARMACIST: PROVIDED, HOWEVER, THAT NOTHING HEREIN SHALL BE
    10  CONSTRUED TO PREVENT A DULY LICENSED MEDICAL PRACTITIONER FROM
    11  DISPENSING, COMPOUNDING OR OTHERWISE GIVING ANY DRUG TO HIS OWN
    12  PATIENTS AFTER DIAGNOSIS OR TREATMENT OF SAID PATIENT, IF SUCH
    13  COMPOUNDING, PREPARING AND DISPENSING IS DONE BY SAID LICENSEE
    14  HIMSELF, NOR SHALL ANYTHING HEREIN PREVENT ANY PERSON FROM
    15  SELLING OR DISTRIBUTING AT RETAIL HOUSEHOLD REMEDIES OR
    16  PROPRIETARY MEDICINES WHEN THE SAME ARE OFFERED FOR SALE OR SOLD
    17  IN THE ORIGINAL PACKAGES WHICH HAVE BEEN PUT UP READY FOR SALE
    18  TO CONSUMERS, PROVIDED HOUSEHOLD REMEDIES OR PROPRIETARY
    19  MEDICINES SHALL NOT INCLUDE ANY CONTROLLED SUBSTANCES OR NON-
    20  PROPRIETARY DRUG UNDER THE ACT OF APRIL 14, 1972 (P.L.233,
    21  NO.64), KNOWN AS "THE CONTROLLED SUBSTANCE, DRUG, DEVICE AND
    22  COSMETIC ACT."
    23     * * *
    24     (8)  ANY PERSON, FIRM OR CORPORATION TO USE THE TITLE
    25  "PHARMACIST", "ASSISTANT PHARMACIST", "PHARMACY TECHNICIAN,"
    26  "PHARMACY TECHNICIAN TRAINEE," "DRUGGIST"[,] OR "APOTHECARY",
    27  EXCEPT A PERSON DULY LICENSED AS A PHARMACIST OR REGISTERED AS A
    28  PHARMACY TECHNICIAN IN PENNSYLVANIA, OR ANY PERSON TO CONDUCT OR
    29  TRANSACT BUSINESS UNDER A NAME WHICH CONTAINS AS PART THEREOF
    30  THE WORDS "DRUG STORE", "PHARMACY", "DRUGS", "MEDICINE STORE",
    20070H1250B2227                 - 16 -     

     1  "MEDICINES", "DRUG SHOP," "APOTHECARY," "PHARMACEUTICAL,"
     2  "HOMEOPATHIC," "HOMEOPATHY" OR ANY TERM HAVING A SIMILAR
     3  MEANING, OR IN ANY MANNER BY ADVERTISEMENT, DISPLAY OF SHOW
     4  GLOBES OR OTHERWISE DESCRIBE OR REFER TO THE PLACE OF THE
     5  CONDUCTED BUSINESS OR PERSON, UNLESS THE PLACE IS A PHARMACY
     6  DULY ISSUED A PERMIT BY THE STATE BOARD OF PHARMACY.
     7     * * *
     8     SECTION 8.1.  INJUNCTION.--IT SHALL BE UNLAWFUL FOR ANY
     9  PERSON TO PRACTICE OR ATTEMPT TO OFFER TO PRACTICE PHARMACY OR
    10  AS A PHARMACY TECHNICIAN, AS DEFINED IN THIS ACT, WITHOUT HAVING
    11  AT THE TIME OF SO DOING A VALID, UNEXPIRED, UNREVOKED AND
    12  UNSUSPENDED LICENSE OR REGISTRATION ISSUED UNDER THIS ACT. THE
    13  UNLAWFUL PRACTICE OF PHARMACY AS DEFINED IN THIS ACT MAY BE
    14  ENJOINED BY THE COURTS ON PETITION OF THE BOARD OR THE
    15  COMMISSIONER OF PROFESSIONAL AND OCCUPATIONAL AFFAIRS. IN ANY
    16  SUCH PROCEEDING IT SHALL NOT BE NECESSARY TO SHOW THAT ANY
    17  PERSON IS INDIVIDUALLY INJURED BY THE ACTIONS COMPLAINED OF. IF
    18  IT IS FOUND THAT THE RESPONDENT HAS ENGAGED IN THE UNLAWFUL
    19  PRACTICE OF PHARMACY, THE COURT SHALL ENJOIN HIM OR HER FROM SO
    20  PRACTICING UNLESS AND UNTIL HE OR SHE HAS BEEN DULY LICENSED.
    21  PROCEDURE IN SUCH CASES SHALL BE THE SAME AS IN ANY OTHER
    22  INJUNCTION SUIT. THE REMEDY BY INJUNCTION HEREBY GIVEN IS IN
    23  ADDITION TO ANY OTHER CIVIL OR CRIMINAL PROSECUTION AND
    24  PUNISHMENT.
    25     SECTION 8.  SECTION 9.1(A) OF THE ACT, ADDED JUNE 29, 2002
    26  (P.L.673, NO.102), IS AMENDED TO READ:
    27     SECTION 9.1.  DRUG THERAPY PROTOCOLS.--(A)  A [PHARMACIST]
    28  LICENSED PHARMACIST, INDIVIDUALLY, OR IN AN INSTITUTIONAL OR
    29  NON-INSTITUTIONAL SETTING SHALL BE PERMITTED TO ENTER INTO A
    30  WRITTEN AGREEMENT OR PROTOCOL WITH A LICENSED PHYSICIAN
    20070H1250B2227                 - 17 -     

     1  AUTHORIZING THE MANAGEMENT OF DRUG THERAPY IN AN INSTITUTIONAL
     2  SETTING.
     3     * * *
     4     SECTION 9.  NO INDIVIDUAL IS REQUIRED TO BE REGISTERED AS A
     5  PHARMACY TECHNICIAN UNDER SECTION 2.1 OF THE ACT UNTIL TWO YEARS
     6  AFTER THE STATE BOARD OF PHARMACY HAS PROMULGATED REGULATIONS
     7  UNDER SECTION 6 OF THIS ACT.
     8     SECTION 10.  THE STATE BOARD OF PHARMACY SHALL PROMULGATE
     9  REGULATIONS TO IMPLEMENT THE AMENDMENT OF SECTION 2.1 AND 9.1(A)
    10  OF THE ACT WITHIN 18 MONTHS OF THE EFFECTIVE DATE OF THIS
    11  SECTION.
    12     SECTION 11.  THIS ACT SHALL TAKE EFFECT IN 60 DAYS.












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