THE GENERAL ASSEMBLY OF PENNSYLVANIA

SENATE BILL

INTRODUCED BY SOLOBAY, COSTA, TARTAGLIONE, ALLOWAY, BOSCOLA, BROWNE, FERLO, FONTANA AND WAUGH, SEPTEMBER 20, 2011

REFERRED TO CONSUMER PROTECTION AND PROFESSIONAL LICENSURE, SEPTEMBER 20, 2011  

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

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

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:

(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.

(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

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

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.