Bill Text: PA HB2251 | 2009-2010 | Regular Session | Introduced

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Bill Title: 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 Public Welfare.

Spectrum: Slight Partisan Bill (Democrat 16-8)

Status: (Introduced - Dead) 2010-02-09 - Referred to HEALTH AND HUMAN SERVICES [HB2251 Detail]

Download: Pennsylvania-2009-HB2251-Introduced.html

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PRINTER'S NO. 3211
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No. 2251 Session of2010
INTRODUCED BY SOLOBAY, McGEEHAN, BELFANTI, BRIGGS, CARROLL, CREIGHTON, EVERETT, GINGRICH, GROVE, GRUCELA, HARHAI, LONGIETTI, MANN, MILLARD, MOUL, MUNDY, M. O'BRIEN, READSHAW, SIPTROTH, SWANGER, WATERS AND WHITE, FEBRUARY 9, 2010
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES, FEBRUARY 9, 2010
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 Public Welfare.
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
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
Public Welfare or a federally qualified health center, as
designated by Federal regulation.
"Board." The State Board of Pharmacy of the Commonwealth.
"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.
"Pharmacist." A pharmacist licensed by the State Board of
Pharmacy.
"Pharmacy." A pharmacy licensed by the State Board of
Pharmacy.
"Prescribing practitioner." A health care practitioner
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.
"Unit dose system." A system in which all 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
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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 any person or 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 Pennsylvania 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.
(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 all State laws, rules and regulations
applicable to the program.
Section 5. Eligibility requirements for recipients of donated
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prescription drugs.
Recipients of donated prescription drugs must meet the
following eligibility requirements:
(1) An individual who receives a donated prescription
drug from an approved clinic must be a resident of
Pennsylvania.
(2) The income of a recipient under this act may not
exceed 200% of the Federal poverty level.
Section 6. Restocking of prescription drugs.
A person or health care facility 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
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, or 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.
Section 7. Inspection, repackaging and distribution of donated
prescription drugs.
The following apply to the inspection, repackaging and
distribution of donated prescription drugs:
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(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
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 Public Welfare 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.
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(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 Public Welfare
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.
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 person or 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
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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. Immunity granted under this section is solely
applicable to the donation, acceptance, distribution, dispensing
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
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 Public Welfare 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
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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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