1Providing for the establishment, implementation and
2administration of a program for the return of prescription
3drugs; and imposing additional powers and duties on the State
4Board of Pharmacy, the Department of Health and the
5Department of Public Welfare.

6The General Assembly of the Commonwealth of Pennsylvania
7hereby enacts as follows:

8Section 1. Short title.

9This act shall be known and may be cited as the Prescription
10Drug Donation Program Act.

11Section 2. Definitions.

12The following words and phrases when used in this act shall
13have the meanings given to them in this section unless the
14context clearly indicates otherwise:

15"Approved clinic." An organized community-based clinic
16offering primary health care services to individuals and
17families who cannot pay for their health care, to medical
18assistance clients or to residents of medically underserved

1areas or health professionals shortage areas, approved by the
2State Board of Pharmacy for the purpose of dispensing donated
3prescription drugs to patients who are indigent. The term may
4include a State health center, nonprofit community-based clinic
5as approved by the Department of Health or the Department of
6Public Welfare or a federally qualified health center, as
7designated by Federal regulation.

8"Board." The State Board of Pharmacy of the Commonwealth.

9"Closed drug delivery system." A system in which the control
10of a unit dose medication is maintained by a health care
11facility, health clinic, hospital, pharmacy or physician's
12office rather than an individual patient.

13"Controlled substance." As defined in section 2 of the act
14of April 14, 1972 (P.L.233, No.64), known as The Controlled
15Substance, Drug, Device and Cosmetic Act.

16"Health care facility." As defined in section 103 of the act
17of July 19, 1979 (P.L.130, No.48), known as the Health Care
18Facilities Act.

19"Health clinic." A for-profit or nonprofit clinic providing
20health services.

21"Hospital." An entity licensed as a hospital under the act
22of July 19, 1979 (P.L.130, No.48), known as the Health Care
23Facilities Act.

24"Pharmacist." A pharmacist licensed by the State Board of
25Pharmacy.

26"Pharmacy." A pharmacy licensed by the State Board of
27Pharmacy.

28"Physician's office." The office of a person licensed to
29practice medicine and surgery or osteopathic medicine and
30surgery.

1"Prescribing practitioner." A health care practitioner
2licensed under the laws of this Commonwealth who is authorized
3to prescribe prescription drugs.

4"Prescription drug." A drug that requires a prescription to
5be dispensed in this Commonwealth. The term includes a cancer
6drug, but does not include a controlled substance.

7"Program." The Prescription Drug Donation Program
8established under section 3.

9"Unit dose system." A system in which the individually
10sealed unit doses are physically connected as a unit.

11"Vendor pharmacy." A licensed pharmacy participating in the
12program that inspects, packages, repackages or prepares a
13manufacturer-sealed container, unit dose package or unit of
14issue package of donated prescription drugs and distributes them
15to an approved clinic.

16Section 3. Establishment.

17The board shall establish a Prescription Drug Donation
18Program consistent with public health and safety standards
19through which a health care facility may donate unused
20prescription drugs to vendor pharmacies for inspection,
21repackaging and distribution of the donated drugs to approved
22clinics, which then dispense the drugs to persons who are
23residents of Pennsylvania and who meet the eligibility
24requirements of the program. Participation in the program shall
25be voluntary.

26Section 4. Eligibility requirements for participating entities.

27Eligibility requirements for participating entities are as
28follows:

29(1) An entity participating in the program must be
30approved by the board for the purpose of receiving,

1distributing and dispensing donated prescription drugs.

2(2) A participating vendor pharmacy must be licensed by
3the board.

4(3) A participating approved clinic must be licensed by
5the Department of Health.

6(4) A participating vendor pharmacy and approved clinic
7must comply with all Federal and State laws, rules and
8regulations applicable to the storage and distribution of
9drugs.

10(5) A participating vendor pharmacy and approved clinic
11must comply with the State laws, rules and regulations
12applicable to the program.

13Section 5. Eligibility requirements for recipients of donated
14prescription drugs.

15Recipients of donated prescription drugs must meet the
16following eligibility requirements:

17(1) An individual who receives a donated prescription
18drug from an approved clinic must be a resident of
19Pennsylvania.

20(2) The income of a recipient under this act may not
21exceed 200% of the Federal poverty level.

22Section 6. Acceptance and restocking of prescription drugs.

23A health care facility that is part of a closed drug delivery
24system may return to a vendor pharmacy a prescription drug under
25the following conditions:

26(1) the prescription drug must be in the original
27unopened, sealed and tamper-evident unit dose packaging. A
28prescription drug packaged in single-unit doses may be
29accepted if the outside packaging is opened but the single-
30unit dose packaging is unopened or not tampered with;

1(2) the donated prescription drug retains the drug name,
2strength, manufacturer identifier, lot and expiration date as
3originally labeled by the pharmacy or manufacturer. The
4prescription drug cannot be accepted by a vendor pharmacy if
5the prescription drug bears an expiration date that is
6earlier than six months after the date the prescription drug
7was restocked, or the prescription drug is adulterated or
8misbranded or the prescription drug requires storage
9temperatures other than normal room temperature as specified
10by the manufacturer and United States Pharmacopoeia; or

11(3) in the case of controlled substances, as it is
12allowed by Federal law.

13A prescription drug that may only be dispensed to a patient
14registered with the drug's manufacturer in accordance with the
15requirements of the Food and Drug Administration may not be
16accepted or distributed under the provisions of the program.

17Section 7. Inspection, repackaging and distribution of donated
18prescription drugs.

19The following apply to the inspection, repackaging and
20distribution of donated prescription drugs:

21(1) The pharmacist at a vendor pharmacy shall determine
22by examination, testing or other investigation that donated
23prescription drugs are not adulterated or misbranded.

24(2) The pharmacist at a vendor pharmacy shall determine
25that the conditions under which the drug has been delivered,
26stored and handled before and during return to the pharmacy
27have preserved proper integrity, stability and labeling of
28the drug and that the drug labeling or packaging has not been
29altered or defaced and the drug name, strength, manufacturer
30identifier, lot and expiration date are retrievable.

1(3) If repackaging and relabeling are required, a vendor
2pharmacy shall repackage and relabel donated prescription
3drugs in accordance with the rules and regulations of the
4board.

5(4) A vendor pharmacy shall distribute returned
6prescription drugs to an approved clinic upon request by the
7approved clinic if the requested prescription drugs are
8available.

9(5) A vendor pharmacy may charge an approved clinic, if
10necessary, a repackaging and relabeling fee equal to no more
11than the maximum dispensing fee authorized by the Department
12of Public Welfare regulations under the medical assistance
13program.

14Section 8. Dispensing of donated prescription drugs.

15(a) General rule.--An approved clinic may dispense donated
16prescription drugs in compliance with applicable Federal and
17State laws and regulations for dispensing prescription drugs.
18The prescription drugs shall only be dispensed by an approved
19clinic pursuant to a prescription issued by a prescribing
20practitioner.

21(b) Fee.--An approved clinic may charge the recipient of a
22donated drug a handling fee, equal to no more than the maximum
23dispensing fee authorized by the Department of Public Welfare
24regulations under the medical assistance program.

25Section 9. Storage of donated prescription drugs.

26A vendor pharmacy that accepts donated prescription drugs and
27an approved clinic that dispenses donated prescription drugs
28under the program shall:

29(1) Comply with all applicable provisions of Federal and
30State law relating to the storage of prescription drugs.

1(2) Store donated prescription drugs in a location
2separate from other drugs.

3Section 10. Recordkeeping.

4The following recordkeeping requirements shall apply:

5(1) A vendor pharmacy shall record and log the exact
6quantity, name and strength of donated prescription drugs
7upon receipt from a health care facility, and prior to
8distributing the drugs to an approved clinic.

9(2) An approved clinic that receives donated
10prescription drugs from a vendor pharmacy shall record the
11receipt and verify the quantity, name and strength of the
12drugs.

13(3) An approved clinic shall keep a complete record of
14the drugs dispensed under this program to eligible
15individuals.

16(4) Records required as part of the program shall be
17maintained separately from other records.

18Section 11. Immunity.

19A person or entity, acting in good faith, who exercises
20reasonable care in donating, accepting, distributing, dispensing
21or manufacturing prescription drugs donated and utilized under
22the program shall be immune from civil or criminal liability or
23professional disciplinary action for any injury, death or loss
24to a person or property relating to activities under the
25program. The immunity includes, but is not limited to, immunity 
26from liability for failure to transfer or communicate product or 
27consumer information or the expiration of the donated 
28prescription drug. Immunity granted under this section is solely
29applicable to the donation, acceptance, distribution, dispensing
30or manufacture of the actual medication donated to the program

1and is explicitly not a general waiver of liability.

2Section 12. Regulations.

3The board shall promulgate regulations to carry out the
4purposes of this act within 90 days of the effective date of
5this section. The regulations shall include:

6(1) Income eligibility criteria and other standards and
7procedures for individuals participating in the program,
8determined by the Department of Public Welfare in conjunction
9with the board.

10(2) Standards and procedures for inspecting donated
11drugs to determine that the original unit dose packaging is
12sealed and tamper-evident and that the drugs are
13unadulterated, safe and suitable for dispensing.

14(3) Necessary forms for administration of the program,
15including forms for use by entities permitted to accept,
16distribute or dispense donated prescription drugs under the
17program.

18(4) Categories of prescription drugs that the program
19will accept for dispensing and categories of prescription
20drugs that the program will not accept for dispensing and the
21reason that the prescription drugs will not be accepted.

22(5) Informed consent forms for recipients of donated
23prescription drugs through the program indicating that the
24prescription drugs have been restocked and redistributed.

25(6) Provisions for recalls of the prescription drug if
26necessary.

27(7) Procedures for entities participating in the program
28to minimize theft and diversion.

29(8) Any other regulations the board deems necessary to
30implement and administer the program.

1Section 20. Effective date.

2This act shall take effect in 60 days.