H0353B2066A07955 DMS:EJH 06/20/18 #90 A07955
AMENDMENTS TO HOUSE BILL NO. 353
Sponsor: SENATOR BAKER
Printer's No. 2066
Amend Bill, page 1, line 10, by inserting after "for"
definitions and for
Amend Bill, page 1, lines 14 through 16, by striking out all
of said lines and inserting
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:
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:
Amend Bill, page 2, line 3, by inserting a bracket before
"emergency"
Amend Bill, page 2, line 3, by inserting a bracket after
"emergency"
Amend Bill, page 2, line 7, by inserting after "the"
All electronic prescription applications shall meet the
requirements outlined in 21 C.F.R. § 1311.120 (relating to
electronic prescription application requirements).
Amend Bill, page 2, line 12, by inserting after "available"
to be issued or received
Amend Bill, page 2, line 13, by striking out the semicolon
after "failure" and inserting
, 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;
Amend Bill, page 2, lines 17 and 18, by striking out
"Internet access OR AN ELECTRONIC HEALTH RECORD SYSTEM ; " in line
17 and all of line 18 and inserting
either of the following:
(i) Internet access; or
(ii) an electronic health record system;
Amend Bill, page 2, line 26, by striking out the period after
"condition" and inserting
;
(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
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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
administered by the department.
Amend Bill, page 2, line 29, by inserting a bracket before
"or"
Amend Bill, page 2, line 29, by striking out the bracket
before the comma after "IV"
Amend Bill, page 2, line 29, by inserting after "may]"
, IV or V
Amend Bill, page 3, line 1, by striking out "emergency"
Amend Bill, page 3, line 7, by inserting after "the"
All electronic prescription applications shall meet the
requirements outlined in 21 C.F.R. § 1311.120.
Amend Bill, page 3, lines 17 and 18, by striking out
"Internet access OR AN ELECTRONIC HEALTH RECORD SYSTEM ; " in line
17 and all of line 18 and inserting
either of the following:
(i) Internet access; or
(ii) an electronic health record system;
Amend Bill, page 3, line 26, by striking out the period after
"condition" and inserting
;
(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;
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(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
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
department in compliance with the act of October 27, 2014
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(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.
Amend Bill, page 3, line 28, by striking out "2" and
inserting
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