PRINTER'S NO. 72
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
79
Session of
2017
INTRODUCED BY PASHINSKI, DEAN, NEILSON, MURT, READSHAW, KINSEY,
BOBACK, V. BROWN, WARD, MOUL, CALTAGIRONE, ROZZI, McCARTER,
PEIFER AND DeLUCA, JANUARY 23, 2017
REFERRED TO COMMITTEE ON HEALTH, JANUARY 23, 2017
AN ACT
Providing for the establishment, implementation and
administration of a program for the return of prescription
drugs; and imposing additional powers and duties on the State
Board of Pharmacy, the Department of Health and the
Department of Human Services.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Short title.
This act shall be known and may be cited as the Prescription
Drug Donation Program Act.
Section 2. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Approved clinic." An organized community-based clinic
offering primary health care services to individuals and
families who cannot pay for their health care, to medical
assistance clients or to residents of medically underserved
areas or health professionals shortage areas, approved by the
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State Board of Pharmacy for the purpose of dispensing donated
prescription drugs to patients who are indigent. The term may
include a State health center, nonprofit community-based clinic
as approved by the Department of Health or the Department of
Human Services or a federally qualified health center, as
designated by Federal regulation.
"Board." The State Board of Pharmacy of the Commonwealth.
"Closed drug delivery system." A system in which the control
of a unit dose medication is maintained by a health care
facility, health clinic, hospital, pharmacy or physician's
office rather than an individual patient.
"Controlled substance." As defined in section 2 of the act
of April 14, 1972 (P.L.233, No.64), known as The Controlled
Substance, Drug, Device and Cosmetic Act.
"Health care facility." As defined in section 103 of the act
of July 19, 1979 (P.L.130, No.48), known as the Health Care
Facilities Act.
"Health clinic." A for-profit or nonprofit clinic providing
health services.
"Hospital." An entity licensed as a hospital under the act
of July 19, 1979 (P.L.130, No.48), known as the Health Care
Facilities Act.
"Pharmacist." A pharmacist licensed by the State Board of
Pharmacy.
"Pharmacy." A pharmacy licensed by the State Board of
Pharmacy.
"Physician's office." The office of a person licensed to
practice medicine and surgery or osteopathic medicine and
surgery.
"Prescribing practitioner." A health care practitioner
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licensed under the laws of this Commonwealth who is authorized
to prescribe prescription drugs.
"Prescription drug." A drug that requires a prescription to
be dispensed in this Commonwealth. The term includes a cancer
drug but does not include a controlled substance.
"Program." The Prescription Drug Donation Program
established under section 3.
"Unit dose system." A system in which the individually
sealed unit doses are physically connected as a unit.
"Vendor pharmacy." A licensed pharmacy participating in the
program that inspects, packages, repackages or prepares a
manufacturer-sealed container, unit dose package or unit of
issue package of donated prescription drugs and distributes them
to an approved clinic.
Section 3. Establishment.
The board shall establish a Prescription Drug Donation
Program consistent with public health and safety standards
through which a health care facility may donate unused
prescription drugs to vendor pharmacies for inspection,
repackaging and distribution of the donated drugs to approved
clinics, which then dispense the drugs to persons who are
residents of this Commonwealth and who meet the eligibility
requirements of the program. Participation in the program shall
be voluntary.
Section 4. Eligibility requirements for participating entities.
Eligibility requirements for participating entities are as
follows:
(1) An entity participating in the program must be
approved by the board for the purpose of receiving,
distributing and dispensing donated prescription drugs.
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(2) A participating vendor pharmacy must be licensed by
the board.
(3) A participating approved clinic must be licensed by
the Department of Health.
(4) A participating vendor pharmacy and approved clinic
must comply with all Federal and State laws, rules and
regulations applicable to the storage and distribution of
drugs.
(5) A participating vendor pharmacy and approved clinic
must comply with the State laws, rules and regulations
applicable to the program.
Section 5. Eligibility requirements for recipients of donated
prescription drugs.
Recipients of donated prescription drugs must meet the
following eligibility requirements:
(1) Be a resident of this Commonwealth.
(2) Not have income exceeding 200% of the Federal
poverty level.
Section 6. Acceptance and restocking of prescription drugs.
A health care facility that is part of a closed drug delivery
system may return to a vendor pharmacy a prescription drug under
the following conditions:
(1) the prescription drug must be in the original
unopened, sealed and tamper-evident unit dose packaging. A
prescription drug packaged in single-unit doses may be
accepted if the outside packaging is opened but the single-
unit dose packaging is unopened or not tampered with;
(2) the donated prescription drug retains the drug name,
strength, manufacturer identifier, lot and expiration date as
originally labeled by the pharmacy or manufacturer. The
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prescription drug cannot be accepted by a vendor pharmacy if
the prescription drug bears an expiration date that is
earlier than six months after the date the prescription drug
was restocked, the prescription drug is adulterated or
misbranded or the prescription drug requires storage
temperatures other than normal room temperature as specified
by the manufacturer and United States Pharmacopoeia; or
(3) in the case of controlled substances, as it is
allowed by Federal law.
A prescription drug that may only be dispensed to a patient
registered with the drug's manufacturer in accordance with the
requirements of the Food and Drug Administration may not be
accepted or distributed under the provisions of the program.
Section 7. Inspection, repackaging and distribution of donated
prescription drugs.
The following apply to the inspection, repackaging and
distribution of donated prescription drugs:
(1) The pharmacist at a vendor pharmacy shall determine
by examination, testing or other investigation that donated
prescription drugs are not adulterated or misbranded.
(2) The pharmacist at a vendor pharmacy shall determine
that the conditions under which the drug has been delivered,
stored and handled before and during return to the pharmacy
have preserved proper integrity, stability and labeling of
the drug and that the drug labeling or packaging has not been
altered or defaced and the drug name, strength, manufacturer
identifier, lot and expiration date are retrievable.
(3) If repackaging and relabeling are required, a vendor
pharmacy shall repackage and relabel donated prescription
drugs in accordance with the rules and regulations of the
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board.
(4) A vendor pharmacy shall distribute returned
prescription drugs to an approved clinic upon request by the
approved clinic if the requested prescription drugs are
available.
(5) A vendor pharmacy may charge an approved clinic, if
necessary, a repackaging and relabeling fee equal to no more
than the maximum dispensing fee authorized by the Department
of Human Services regulations under the medical assistance
program.
Section 8. Dispensing of donated prescription drugs.
(a) General rule.--An approved clinic may dispense donated
prescription drugs in compliance with applicable Federal and
State laws and regulations for dispensing prescription drugs.
The prescription drugs shall only be dispensed by an approved
clinic pursuant to a prescription issued by a prescribing
practitioner.
(b) Fee.--An approved clinic may charge the recipient of a
donated drug a handling fee, equal to no more than the maximum
dispensing fee authorized by the Department of Human Services
regulations under the medical assistance program.
Section 9. Storage of donated prescription drugs.
A vendor pharmacy that accepts donated prescription drugs and
an approved clinic that dispenses donated prescription drugs
under the program shall:
(1) Comply with all applicable provisions of Federal and
State law relating to the storage of prescription drugs.
(2) Store donated prescription drugs in a location
separate from other drugs.
Section 10. Recordkeeping.
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The following recordkeeping requirements shall apply:
(1) A vendor pharmacy shall record and log the exact
quantity, name and strength of donated prescription drugs
upon receipt from a health care facility and prior to
distributing the drugs to an approved clinic.
(2) An approved clinic that receives donated
prescription drugs from a vendor pharmacy shall record the
receipt and verify the quantity, name and strength of the
drugs.
(3) An approved clinic shall keep a complete record of
the drugs dispensed under this program to eligible
individuals.
(4) Records required as part of the program shall be
maintained separately from other records.
Section 11. Immunity.
A person or entity, acting in good faith, who exercises
reasonable care in donating, accepting, distributing, dispensing
or manufacturing prescription drugs donated and utilized under
the program shall be immune from civil or criminal liability or
professional disciplinary action for any injury, death or loss
to a person or property relating to activities under the
program. The immunity includes, but is not limited to, immunity
from liability for failure to transfer or communicate product or
consumer information or the expiration of the donated
prescription drug. Immunity granted under this section is solely
applicable to the donation, acceptance, distribution, dispensing
or manufacture of the actual medication donated to the program
and is explicitly not a general waiver of liability.
Section 12. Regulations.
The board shall promulgate regulations to carry out the
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purposes of this act within 90 days of the effective date of
this section. The regulations shall include:
(1) Income eligibility criteria and other standards and
procedures for individuals participating in the program,
determined by the Department of Human Services in conjunction
with the board.
(2) Standards and procedures for inspecting donated
drugs to determine that the original unit dose packaging is
sealed and tamper-evident and that the drugs are
unadulterated, safe and suitable for dispensing.
(3) Necessary forms for administration of the program,
including forms for use by entities permitted to accept,
distribute or dispense donated prescription drugs under the
program.
(4) Categories of prescription drugs that the program
will accept for dispensing and categories of prescription
drugs that the program will not accept for dispensing and the
reason that the prescription drugs will not be accepted.
(5) Informed consent forms for recipients of donated
prescription drugs through the program indicating that the
prescription drugs have been restocked and redistributed.
(6) Provisions for recalls of the prescription drug if
necessary.
(7) Procedures for entities participating in the program
to minimize theft and diversion.
(8) Any other regulations the board deems necessary to
implement and administer the program.
Section 13. Effective date.
This act shall take effect in 60 days.
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