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SENATE AMENDED
PRIOR PRINTER'S NOS. 365, 1911, 2066
PRINTER'S NO. 3779
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
353
Session of
2017
INTRODUCED BY NESBIT, MARSICO, NEILSON, CRUZ, DRISCOLL, COX,
MILLARD, HILL-EVANS, CARROLL, PHILLIPS-HILL, PICKETT,
A. HARRIS, MURT, WARD, IRVIN, GAINEY, SOLOMON, M. QUINN,
RADER, STEPHENS, WATSON, ZIMMERMAN, DEAN, BENNINGHOFF,
BARRAR, D. MILLER, OBERLANDER, DAVIS, MICCARELLI, RAPP AND
DOWLING, FEBRUARY 6, 2017
SENATOR BAKER, HEALTH AND HUMAN SERVICES, IN SENATE, AS AMENDED,
JUNE 20, 2018
AN ACT
Amending the act of April 14, 1972 (P.L.233, No.64), entitled
"An act relating to the manufacture, sale and possession of
controlled substances, other drugs, devices and cosmetics;
conferring powers on the courts and the secretary and
Department of Health, and a newly created Pennsylvania Drug,
Device and Cosmetic Board; establishing schedules of
controlled substances; providing penalties; requiring
registration of persons engaged in the drug trade and for the
revocation or suspension of certain licenses and
registrations; and repealing an act," further providing for
DEFINITIONS AND FOR professional prescription,
administration, and dispensing.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 11(a) and (b) of the act of April 14,
1972 (P.L.233, No.64), known as The Controlled Substance, Drug,
Device and Cosmetic Act, are amended to read:
SECTION 1. SECTION 2 OF THE ACT OF APRIL 14, 1972 (P.L.233,
NO.64), KNOWN AS THE CONTROLLED SUBSTANCE, DRUG, DEVICE AND
COSMETIC ACT, IS AMENDED BY ADDING A DEFINITION TO READ:
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SECTION 2. DEFINITIONS.--* * *
(B) AS USED IN THIS ACT:
* * *
"TEMPORARY TECHNOLOGICAL OR ELECTRICAL FAILURE" MEANS ANY
FAILURE OF A COMPUTER SYSTEM, APPLICATION OR DEVICE, OR THE LOSS
OF ELECTRICAL POWER TO THAT SYSTEM, APPLICATION OR DEVICE, OR
ANY OTHER SERVICE INTERRUPTION TO A COMPUTER SYSTEM, APPLICATION
OR DEVICE IN A MANNER THAT REASONABLY PREVENTS A PRACTITIONER
FROM UTILIZING HIS OR HER CERTIFIED ELECTRONIC PRESCRIBING
APPLICATION TO TRANSMIT AN ELECTRONIC PRESCRIPTION FOR A
CONTROLLED SUBSTANCE IN ACCORDANCE WITH THIS ACT AND FEDERAL
REQUIREMENTS.
* * *
SECTION 2. SECTION 4(3)(VII)1 OF THE ACT IS AMENDED TO READ:
SECTION 4. SCHEDULES OF CONTROLLED SUBSTANCES.--THE
FOLLOWING SCHEDULES INCLUDE THE CONTROLLED SUBSTANCES LISTED OR
TO BE LISTED BY WHATEVER OFFICIAL NAME, COMMON OR USUAL NAME,
CHEMICAL NAME, OR TRADE NAME DESIGNATED.
* * *
(3) SCHEDULE III--IN DETERMINING THAT A SUBSTANCE COMES
WITHIN THIS SCHEDULE, THE SECRETARY SHALL FIND: A POTENTIAL FOR
ABUSE LESS THAN THE SUBSTANCES LISTED IN SCHEDULES I AND II;
WELL DOCUMENTED AND CURRENTLY ACCEPTED MEDICAL USE IN THE UNITED
STATES; AND ABUSE MAY LEAD TO MODERATE OR LOW PHYSICAL
DEPENDENCE OR HIGH PSYCHOLOGICAL DEPENDENCE. THE FOLLOWING
CLASSES OF CONTROLLED SUBSTANCES ARE INCLUDED IN THIS SCHEDULE:
* * *
(VII) ANABOLIC STEROID INCLUDES ANY MATERIAL, COMPOUND,
MIXTURE OR PREPARATION THAT INCLUDES ANY OF THE FOLLOWING OR ANY
ISOMER, ESTER, SALT OR DERIVATIVE OF ANY OF THE FOLLOWING THAT
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ACTS IN THE SAME MANNER ON THE HUMAN BODY:
1. CHORIONIC GONADOTROPIN, EXCEPT WHEN USED FOR INJECTION OR
IMPLANTATION IN CATTLE OR ANY OTHER NONHUMAN SPECIES AND WHEN
THAT USE IS APPROVED BY THE FOOD AND DRUG ADMINISTRATION.
* * *
SECTION 3. SECTION 11(A) AND (B) OF THE ACT IS AMENDED AND
THE SECTION IS AMENDED BY ADDING SUBSECTIONS TO READ:
Section 11. Professional Prescription, Administration, and
Dispensing.--(a) Except when dispensed or administered directly
to the patient by a practitioner or his authorized agent, other
than a pharmacist, to an ultimate user, no controlled substance
in Schedule II[, may] shall be dispensed without [the written]
an electronic prescription of a practitioner, except in
[emergency] situations, as prescribed by the secretary by
regulation. No prescription for a controlled substance in
Schedule II may be refilled. ALL ELECTRONIC PRESCRIPTION
APPLICATIONS SHALL MEET THE REQUIREMENTS OUTLINED IN 21 C.F.R. §
1311.120 (RELATING TO ELECTRONIC PRESCRIPTION APPLICATION
REQUIREMENTS). The electronic prescription requirement under
this subsection shall not apply if the prescription is issued :
(1) b y a veterinarian;
(2) under circumstances when an electronic prescription is
not available TO BE ISSUED OR RECEIVED due to a temporary
technological or electrical failure ; , AND IN THE INSTANCE OF A
TEMPORARY TECHNOLOGICAL FAILURE, A PRACTITIONER SHALL, WITHIN
SEVENTY-TWO HOURS, SEEK TO CORRECT ANY CAUSE FOR THE FAILURE
THAT IS REASONABLY WITHIN HIS OR HER CONTROL;
(3) by a practitioner and dispensed by a pharmacy located
outside this Commonwealth;
(4) by a practitioner who or health care facility that does
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not have Internet access or an electronic health record system ;
or EITHER OF THE FOLLOWING:
(I) INTERNET ACCESS; OR
(II) AN ELECTRONIC HEALTH RECORD SYSTEM;
(5) by a practitioner treating a patient in an emergency
department or a health care facility u nder circumstances when
the practitioner reasonably determines that electronically
prescribing a controlled substance would be impractical for the
patient to obtain the controlled substance prescribed by
electronic prescription or would cause an untimely delay
resulting in an adverse impact on the patient's medical
condition . ;
(6) FOR A PATIENT ENROLLED IN A HOSPICE PROGRAM OR FOR A
PATIENT RESIDING IN A NURSING HOME OR RESIDENTIAL HEALTH CARE
FACILITY;
(7) FOR CONTROLLED SUBSTANCE COMPOUNDED PRESCRIPTIONS AND
PRESCRIPTIONS CONTAINING CERTAIN ELEMENTS REQUIRED BY THE FOOD
AND DRUG ADMINISTRATION OR ANY OTHER GOVERNMENTAL AGENCY THAT
ARE NOT ABLE TO BE ACCOMPLISHED WITH ELECTRONIC PRESCRIBING;
(8) FOR A PRESCRIPTION ISSUED PURSUANT TO AN ESTABLISHED AND
VALID COLLABORATIVE PRACTICE AGREEMENT BETWEEN A PRACTITIONER
AND A PHARMACIST, A STANDING ORDER OR A DRUG RESEARCH PROTOCOL;
(9) FOR A PRESCRIPTION ISSUED IN AN EMERGENCY SITUATION
PURSUANT TO FEDERAL OR STATE LAW AND REGULATIONS OF THE
DEPARTMENT;
(10) UNDER CIRCUMSTANCES WHERE THE PHARMACY THAT RECEIVES
THE PRESCRIPTION IS NOT SET UP TO PROCESS ELECTRONIC
PRESCRIPTIONS; OR
(11) FOR CONTROLLED SUBSTANCES THAT ARE NOT REQUIRED TO BE
REPORTED TO THE PRESCRIPTION DRUG MONITORING PROGRAM SYSTEM
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ADMINISTERED BY THE DEPARTMENT.
(b) Except when dispensed directly by a practitioner, other
than a pharmacist, to an ultimate user, no controlled substance
in Schedule III [or IV[, may], IV OR V shall be dispensed
without [a written or oral] an electronic prescription of a
practitioner, except in emergency situations, as prescribed by
the secretary by regulation . Such prescriptions shall not be
filled or refilled more than six months after the date thereof
or be refilled more than five times after the date of the
prescription unless renewed by the practitioner. ALL ELECTRONIC
PRESCRIPTION APPLICATIONS SHALL MEET THE REQUIREMENTS OUTLINED
IN 21 C.F.R. § 1311.120. The electronic prescription requirement
under this subsection shall not apply if the prescription is
issued :
(1) b y a veterinarian;
(2) under circumstances when an electronic prescription is
not available due to a temporary technological or electrical
failure;
(3) by a practitioner and dispensed by a pharmacy located
outside this Commonwealth;
(4) by a practitioner who or health care facility that does
not have Internet access or an electronic health record system ;
or EITHER OF THE FOLLOWING:
(I) INTERNET ACCESS; OR
(II) AN ELECTRONIC HEALTH RECORD SYSTEM;
(5) by a practitioner treating a patient in an emergency
department or a health care facility u nder circumstances when
the practitioner reasonably determines that electronically
prescribing a controlled substance would be impractical for the
patient to obtain the controlled substance prescribed by
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electronic prescription or would cause an untimely delay
resulting in an adverse impact on the patient's medical
condition . ;
(6) FOR A PATIENT ENROLLED IN A HOSPICE PROGRAM OR FOR A
PATIENT RESIDING IN A NURSING HOME OR RESIDENTIAL HEALTH CARE
FACILITY;
(7) FOR CONTROLLED SUBSTANCE COMPOUNDED PRESCRIPTIONS AND
PRESCRIPTIONS CONTAINING CERTAIN ELEMENTS REQUIRED BY THE FOOD
AND DRUG ADMINISTRATION OR ANY OTHER GOVERNMENTAL AGENCY THAT
ARE NOT ABLE TO BE ACCOMPLISHED WITH ELECTRONIC PRESCRIBING;
(8) FOR A PRESCRIPTION ISSUED PURSUANT TO AN ESTABLISHED AND
VALID COLLABORATIVE PRACTICE AGREEMENT BETWEEN A PRACTITIONER
AND A PHARMACIST, A STANDING ORDER OR A DRUG RESEARCH PROTOCOL;
(9) FOR A PRESCRIPTION ISSUED IN AN EMERGENCY SITUATION
PURSUANT TO FEDERAL OR STATE LAW AND REGULATIONS OF THE BOARD;
(10) UNDER CIRCUMSTANCES WHERE THE PHARMACY THAT RECEIVES
THE PRESCRIPTION IS NOT SET UP TO PROCESS ELECTRONIC
PRESCRIPTIONS; OR
(11) FOR CONTROLLED SUBSTANCES THAT ARE NOT REQUIRED TO BE
REPORTED TO THE PRESCRIPTION DRUG MONITORING PROGRAM SYSTEM
ADMINISTERED BY THE DEPARTMENT.
(B.1) (1) A PRACTITIONER, PHARMACY OR HEALTH CARE FACILITY
THAT DOES NOT MEET AN EXCEPTION TO THE ELECTRONIC PRESCRIBING
REQUIREMENTS UNDER SUBSECTION (A) OR (B) AND IS UNABLE TO TIMELY
COMPLY WITH THE ELECTRONIC PRESCRIBING REQUIREMENTS MAY PETITION
THE DEPARTMENT FOR AN EXEMPTION FROM THE REQUIREMENTS BASED UPON
ECONOMIC HARDSHIP, TECHNICAL LIMITATIONS OR EXCEPTIONAL
CIRCUMSTANCES.
(2) THE DEPARTMENT SHALL ADOPT RULES ESTABLISHING THE FORM
AND SPECIFIC INFORMATION TO BE INCLUDED IN A REQUEST FOR AN
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EXEMPTION.
(3) THE DEPARTMENT MAY APPROVE AN EXEMPTION FOR A PERIOD OF
TIME DETERMINED BY THE DEPARTMENT NOT TO EXCEED ONE YEAR FROM
THE DATE OF APPROVAL AND MAY BE RENEWED ANNUALLY UPON REQUEST
SUBJECT TO DEPARTMENT APPROVAL.
(4) THE DEPARTMENT MAY GRANT ADDITIONAL EXEMPTIONS BEYOND
THE EXEMPTIONS PROVIDED FOR IN SUBSECTIONS (A) AND (B) SUBJECT
TO THE ACT OF JUNE 25, 1982 (P.L.633, NO.181), KNOWN AS THE
REGULATORY REVIEW ACT .
(B.2) A PRESCRIPTION GENERATED ON AN ELECTRONIC SYSTEM AND
PRINTED OR TRANSMITTED VIA FACSIMILE IS NOT AN ELECTRONIC
PRESCRIPTION.
(B.3) (1) A PHARMACIST WHO RECEIVES A WRITTEN, ORAL OR
FAXED PRESCRIPTION SHALL NOT BE REQUIRED TO VERIFY THAT THE
PRESCRIPTION PROPERLY FALLS UNDER ONE OF THE EXCEPTIONS PROVIDED
IN SUBSECTIONS (A) AND (B) FROM THE REQUIREMENT TO
ELECTRONICALLY PRESCRIBE. A PHARMACIST MAY CONTINUE TO DISPENSE
MEDICATIONS FROM THE OTHERWISE VALID WRITTEN, ORAL OR FAXED
PRESCRIPTIONS THAT ARE CONSISTENT WITH CURRENT LAWS AND
REGULATIONS.
(2) IF A PHARMACIST HAS A REASONABLE BELIEF THAT A PATIENT
MAY BE SEEKING A MONITORED PRESCRIPTION DRUG FOR A PURPOSE OTHER
THAN THE TREATMENT OF AN EXISTING MEDICAL CONDITION, THE
PHARMACIST SHALL HAVE THE RESPONSIBILITY DESCRIBED IN 21 C.F.R.
§ 1306.04 (RELATING TO PURPOSE OF ISSUE OF PRESCRIPTION).
(3) A PRACTITIONER SHALL BE SUBJECT TO THE RESPONSIBILITIES
DESCRIBED IN 21 C.F.R. § 1311.102 (RELATING TO PRACTITIONER
RESPONSIBILITIES).
(B.4) THE DEPARTMENT SHALL REQUIRE THE PRESCRIPTION ORIGIN
TO BE SUBMITTED BY DISPENSERS UNDER THE AUTHORITY OF THE
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DEPARTMENT IN COMPLIANCE WITH THE ACT OF OCTOBER 27, 2014
(P.L.2911, NO.191), KNOWN AS THE ACHIEVING BETTER CARE BY
MONITORING ALL PRESCRIPTIONS PROGRAM (ABC-MAP) ACT.
(B.5) A PRACTITIONER WHO VIOLATES SUBSECTION (A) OR (B) IS
SUBJECT TO AN ADMINISTRATIVE PENALTY OF ONE HUNDRED DOLLARS
($100) FOR THE FIRST THROUGH TENTH VIOLATIONS AND TWO HUNDRED
AND FIFTY DOLLARS ($250) FOR EACH SUBSEQUENT VIOLATION AFTER THE
TENTH VIOLATION, UP TO A MAXIMUM OF FIVE THOUSAND DOLLARS
($5,000) PER CALENDAR YEAR. VIOLATIONS SHALL RESET AND SHALL NOT
CARRY OVER TO SUBSEQUENT CALENDAR YEARS. THE ASSESSMENT OF AN
ADMINISTRATIVE PENALTY PURSUANT TO THIS SUBSECTION BY THE
DEPARTMENT TO A PRACTITIONER ALLEGED TO HAVE VIOLATED SUBSECTION
(A) OR (B) SHALL NOT BE REPORTED BY THE DEPARTMENT TO THE
PRACTITIONER'S APPROPRIATE LICENSING BOARD AND SHALL NOT BE
CONSIDERED A DISCIPLINARY ACTION OR NEED TO BE REPORTED BY THE
PRACTITIONER AS A VIOLATION TO THE PRACTITIONER'S APPROPRIATE
LICENSING BOARD. A PRACTITIONER MAY APPEAL THE ASSESSMENT OF AN
ADMINISTRATIVE PENALTY PURSUANT TO 2 PA.C.S. (RELATING TO
ADMINISTRATIVE LAW AND PROCEDURE) .
(B.6) THE DEPARTMENT, WITHIN ONE HUNDRED EIGHTY DAYS OF THE
EFFECTIVE DATE OF THIS SUBSECTION, SHALL PROMULGATE REGULATIONS
NECESSARY TO IMPLEMENT THE REQUIREMENTS OF THIS ACT.
* * *
Section 2 4. This act shall take effect in one year.
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