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| THE GENERAL ASSEMBLY OF PENNSYLVANIA |
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| SENATE BILL |
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| INTRODUCED BY SOLOBAY, COSTA, TARTAGLIONE, ALLOWAY, BOSCOLA, BROWNE, FERLO, FONTANA AND WAUGH, SEPTEMBER 20, 2011 |
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| REFERRED TO CONSUMER PROTECTION AND PROFESSIONAL LICENSURE, SEPTEMBER 20, 2011 |
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| AN ACT |
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1 | Providing for the establishment, implementation and |
2 | administration of a program for the return of prescription |
3 | drugs; and imposing additional powers and duties on the State |
4 | Board of Pharmacy, the Department of Health and the |
5 | Department of Public Welfare. |
6 | The General Assembly of the Commonwealth of Pennsylvania |
7 | hereby enacts as follows: |
8 | Section 1. Short title. |
9 | This act shall be known and may be cited as the Prescription |
10 | Drug Donation Program Act. |
11 | Section 2. Definitions. |
12 | The following words and phrases when used in this act shall |
13 | have the meanings given to them in this section unless the |
14 | context clearly indicates otherwise: |
15 | "Approved clinic." An organized community-based clinic |
16 | offering primary health care services to individuals and |
17 | families who cannot pay for their health care, to medical |
18 | assistance clients or to residents of medically underserved |
19 | areas or health professionals shortage areas, approved by the |
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1 | State Board of Pharmacy for the purpose of dispensing donated |
2 | prescription drugs to patients who are indigent. The term may |
3 | include a State health center, nonprofit community-based clinic |
4 | as approved by the Department of Health or the Department of |
5 | Public Welfare or a federally qualified health center, as |
6 | designated by Federal regulation. |
7 | "Board." The State Board of Pharmacy of the Commonwealth. |
8 | "Controlled substance." As defined in section 2 of the act |
9 | of April 14, 1972 (P.L.233, No.64), known as The Controlled |
10 | Substance, Drug, Device and Cosmetic Act. |
11 | "Health care facility." As defined in section 103 of the act |
12 | of July 19, 1979 (P.L.130, No.48), known as the Health Care |
13 | Facilities Act. |
14 | "Pharmacist." A pharmacist licensed by the State Board of |
15 | Pharmacy. |
16 | "Pharmacy." A pharmacy licensed by the State Board of |
17 | Pharmacy. |
18 | "Prescribing practitioner." A health care practitioner |
19 | licensed under the laws of this Commonwealth who is authorized |
20 | to prescribe prescription drugs. |
21 | "Prescription drug." A drug that requires a prescription to |
22 | be dispensed in this Commonwealth. The term includes a cancer |
23 | drug, but does not include a controlled substance. |
24 | "Program." The Prescription Drug Donation Program. |
25 | "Unit dose system." A system in which all individually |
26 | sealed unit doses are physically connected as a unit. |
27 | "Vendor pharmacy." A licensed pharmacy participating in the |
28 | program that inspects, packages, repackages or prepares a |
29 | manufacturer-sealed container, unit dose package or unit of |
30 | issue package of donated prescription drugs and distributes them |
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1 | to an approved clinic. |
2 | Section 3. Establishment. |
3 | The board shall establish a Prescription Drug Donation |
4 | Program consistent with public health and safety standards |
5 | through which any person or health care facility may donate |
6 | unused prescription drugs to vendor pharmacies for inspection, |
7 | repackaging and distribution of the donated drugs to approved |
8 | clinics, which then dispense the drugs to persons who are |
9 | residents of Pennsylvania and who meet the eligibility |
10 | requirements of the program. Participation in the program shall |
11 | be voluntary. |
12 | Section 4. Eligibility requirements for participating entities. |
13 | Eligibility requirements for participating entities are as |
14 | follows: |
15 | (1) An entity participating in the program must be |
16 | approved by the board for the purpose of receiving, |
17 | distributing and dispensing donated prescription drugs. |
18 | (2) A participating vendor pharmacy must be licensed by |
19 | the board. |
20 | (3) A participating approved clinic must be licensed by |
21 | the Department of Health. |
22 | (4) A participating vendor pharmacy and approved clinic |
23 | must comply with all Federal and State laws, rules and |
24 | regulations applicable to the storage and distribution of |
25 | drugs. |
26 | (5) A participating vendor pharmacy and approved clinic |
27 | must comply with all State laws, rules and regulations |
28 | applicable to the program. |
29 | Section 5. Eligibility requirements for recipients of donated |
30 | prescription drugs. |
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1 | Recipients of donated prescription drugs must meet the |
2 | following eligibility requirements: |
3 | (1) An individual who receives a donated prescription |
4 | drug from an approved clinic must be a resident of |
5 | Pennsylvania. |
6 | (2) The income of a recipient under this act may not |
7 | exceed 200% of the Federal poverty level. |
8 | Section 6. Restocking of prescription drugs. |
9 | A person or health care facility may return to a vendor |
10 | pharmacy a prescription drug under the following conditions: |
11 | (1) The prescription drug must be in the original |
12 | unopened, sealed and tamper-evident unit-dose packaging. A |
13 | prescription drug packaged in single-unit doses may be |
14 | accepted if the outside packaging is opened but the single- |
15 | unit-dose packaging is unopened or not tampered with. |
16 | (2) The donated prescription drug retains the drug name, |
17 | strength, manufacturer identifier, lot and expiration date as |
18 | originally labeled by the pharmacy or manufacturer. The |
19 | prescription drug cannot be accepted by a vendor pharmacy if |
20 | the prescription drug bears an expiration date that is |
21 | earlier than six months after the date the prescription drug |
22 | was restocked, or the prescription drug is adulterated or |
23 | misbranded or the prescription drug requires storage |
24 | temperatures other than normal room temperature as specified |
25 | by the manufacturer and United States Pharmacopoeia. |
26 | Section 7. Inspection, repackaging and distribution of donated |
27 | prescription drugs. |
28 | The following apply to the inspection, repackaging and |
29 | distribution of donated prescription drugs: |
30 | (1) The pharmacist at a vendor pharmacy shall determine |
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1 | by examination, testing or other investigation that donated |
2 | prescription drugs are not adulterated or misbranded. |
3 | (2) The pharmacist at a vendor pharmacy shall determine |
4 | that the conditions under which the drug has been delivered, |
5 | stored and handled before and during return to the pharmacy |
6 | have preserved proper integrity, stability and labeling of |
7 | the drug and that the drug labeling or packaging has not been |
8 | altered or defaced and the drug name, strength, manufacturer |
9 | identifier, lot and expiration date are retrievable. |
10 | (3) If repackaging and relabeling are required, a vendor |
11 | pharmacy shall repackage and relabel donated prescription |
12 | drugs in accordance with the rules and regulations of the |
13 | board. |
14 | (4) A vendor pharmacy shall distribute returned |
15 | prescription drugs to an approved clinic upon request by the |
16 | approved clinic if the requested prescription drugs are |
17 | available. |
18 | (5) A vendor pharmacy may charge an approved clinic, if |
19 | necessary, a repackaging and relabeling fee equal to no more |
20 | than the maximum dispensing fee authorized by the Department |
21 | of Public Welfare regulations under the medical assistance |
22 | program. |
23 | Section 8. Dispensing of donated prescription drugs. |
24 | (a) General rule.--An approved clinic may dispense donated |
25 | prescription drugs in compliance with applicable Federal and |
26 | State laws and regulations for dispensing prescription drugs. |
27 | The prescription drugs shall only be dispensed by an approved |
28 | clinic pursuant to a prescription issued by a prescribing |
29 | practitioner. |
30 | (b) Fee.--An approved clinic may charge the recipient of a |
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1 | donated drug a handling fee, equal to no more than the maximum |
2 | dispensing fee authorized by the Department of Public Welfare |
3 | regulations under the medical assistance program. |
4 | Section 9. Storage of donated prescription drugs. |
5 | A vendor pharmacy that accepts donated prescription drugs and |
6 | an approved clinic that dispenses donated prescription drugs |
7 | under the program shall: |
8 | (1) Comply with all applicable provisions of Federal and |
9 | State law relating to the storage of prescription drugs. |
10 | (2) Store donated prescription drugs in a location |
11 | separate from other drugs. |
12 | Section 10. Recordkeeping. |
13 | The following recordkeeping requirements shall apply: |
14 | (1) A vendor pharmacy shall record and log the exact |
15 | quantity, name and strength of donated prescription drugs |
16 | upon receipt from a person or health care facility, and prior |
17 | to distributing the drugs to an approved clinic. |
18 | (2) An approved clinic that receives donated |
19 | prescription drugs from a vendor pharmacy shall record the |
20 | receipt and verify the quantity, name and strength of the |
21 | drugs. |
22 | (3) An approved clinic shall keep a complete record of |
23 | the drugs dispensed under this program to eligible |
24 | individuals. |
25 | (4) Records required as part of the program shall be |
26 | maintained separately from other records. |
27 | Section 11. Immunity. |
28 | A person or entity, acting in good faith, who exercises |
29 | reasonable care in donating, accepting, distributing, dispensing |
30 | or manufacturing prescription drugs donated and utilized under |
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1 | the program shall be immune from civil or criminal liability or |
2 | professional disciplinary action for any injury, death or loss |
3 | to a person or property relating to activities under the |
4 | program. Immunity granted under this section is solely |
5 | applicable to the donation, acceptance, distribution, dispensing |
6 | of the actual medication donated to the program and is |
7 | explicitly not a general waiver of liability. |
8 | Section 12. Regulations. |
9 | The board shall promulgate regulations to carry out the |
10 | purposes of this act within 90 days of the effective date of |
11 | this section. The regulations shall include: |
12 | (1) Income eligibility criteria and other standards and |
13 | procedures for individuals participating in the program, |
14 | determined by the Department of Public Welfare in conjunction |
15 | with the board. |
16 | (2) Standards and procedures for inspecting donated |
17 | drugs to determine that the original unit-dose packaging is |
18 | sealed and tamper-evident and that the drugs are |
19 | unadulterated, safe and suitable for dispensing. |
20 | (3) Necessary forms for administration of the program, |
21 | including forms for use by entities permitted to accept, |
22 | distribute or dispense donated prescription drugs under the |
23 | program. |
24 | (4) Categories of prescription drugs that the program |
25 | will accept for dispensing and categories of prescription |
26 | drugs that the program will not accept for dispensing and the |
27 | reason that the prescription drugs will not be accepted. |
28 | (5) Informed consent forms for recipients of donated |
29 | prescription drugs through the program indicating that the |
30 | prescription drugs have been restocked and redistributed. |
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1 | (6) Provisions for recalls of the prescription drug if |
2 | necessary. |
3 | (7) Procedures for entities participating in the program |
4 | to minimize theft and diversion. |
5 | (8) Any other regulations the board deems necessary to |
6 | implement and administer the program. |
7 | Section 13. Effective date. |
8 | This act shall take effect in 60 days. |
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