| |
|
| |
| THE GENERAL ASSEMBLY OF PENNSYLVANIA |
| |
| SENATE BILL |
|
| |
| |
| INTRODUCED BY D. WHITE, STOUT, RAFFERTY, O'PAKE, ERICKSON, TARTAGLIONE, FOLMER, WAUGH, FERLO, WARD, BOSCOLA, ARGALL, KITCHEN, ALLOWAY, VANCE, BRUBAKER AND EARLL, JULY 23, 2009 |
| |
| |
| REFERRED TO JUDICIARY, JULY 23, 2009 |
| |
| |
| |
| AN ACT |
| |
1 | Providing for drug redistribution within correctional |
2 | facilities. |
3 | The General Assembly of the Commonwealth of Pennsylvania |
4 | hereby enacts as follows: |
5 | Section 1. Short title. |
6 | This act shall be known and may be cited as the Correctional |
7 | Facilities Drug Redistribution Act. |
8 | Section 2. Definitions. |
9 | The following words and phrases when used in this act shall |
10 | have the meanings given to them in this section unless the |
11 | context clearly indicates otherwise: |
12 | "Correctional facility." A jail, prison, facility, |
13 | institution, group home, prerelease center, community |
14 | corrections center, parole center or any facility that houses a |
15 | a person convicted of a criminal offense, or awaiting trial, |
16 | sentencing or extradition in a criminal proceeding. The term |
17 | includes an institution, facility or unit operated by or for the |
|
1 | Department of Corrections. The term does not include any |
2 | facility or institution operated, supervised or licensed under |
3 | the act of June 13, 1967 (P.L.31, No.21), known as the Public |
4 | Welfare Code. |
5 | "Designated personnel." Correctional facility employees or |
6 | employees of a vendor for a correctional facility licensed by |
7 | the State Board of Medicine, State Board of Osteopathic |
8 | Medicine, State Board of Nursing or State Board of Pharmacy and |
9 | authorized by their scope of practice to administer drugs. |
10 | "Drug." Any medication prescribed by a licensed |
11 | practitioner, either patient specific or stock to a patient in a |
12 | correctional facility. |
13 | "Manufacturer." A company that produces a drug or a Federal |
14 | Drug Administration certified repacker who packages or |
15 | repackages a drug product for distribution. |
16 | "Manufacturer identifier." A manufacturer's name or product |
17 | National Drug Code number. |
18 | "Unit dose package." An individually sealed package that |
19 | contains a single dose drug with the drug name, strength, |
20 | manufacturer identifier, lot number and expiration date of the |
21 | drug on the package. |
22 | "Unit of issue package." A package that includes multiple |
23 | unit dose packages of the same drug. |
24 | "Vendor pharmacy." A licensed pharmacy that packages, |
25 | repackages or prepares a manufacturer-sealed container, unit |
26 | dose package or unit of issue package for delivery to a |
27 | correctional facility. |
28 | Section 3. Return to and redispensing by vendor pharmacy. |
29 | A drug that is issued to a correctional facility and has left |
30 | the control of a pharmacist at a vendor pharmacy may be returned |
|
1 | to its vendor pharmacy for the purpose of redispensing that drug |
2 | to fill other prescriptions for other correctional facilities |
3 | only if the following requirements are met: |
4 | (1) The drug is not a Schedule I, II, III, IV or V |
5 | controlled substance as specified in the act of April 14, |
6 | 1972 (P.L.233, No.64), known as The Controlled Substance, |
7 | Drug, Device and Cosmetic Act. |
8 | (2) The drug is returned to its vendor pharmacy in |
9 | accordance with the vendor pharmacy's written policies and |
10 | procedures that comply with section 4 and the State Board of |
11 | Pharmacy's rules and regulations in regard to delivery, |
12 | storage, labeling and reissuing of the drug. |
13 | (3) The drug is returned to the vendor pharmacy unopened |
14 | and still sealed in the unit dose package, unit of issue |
15 | package, bottle or manufacturer's package. |
16 | (4) Each returned unit dose package, unit of issue |
17 | package or manufacturer's package retains the drug name, |
18 | strength, manufacturer identifier, lot and expiration date as |
19 | originally labeled by the pharmacy or manufacturer. |
20 | (5) The drug issued to the facility was at no time in |
21 | the possession or control of a patient. |
22 | (6) The drug remained in a controlled environment of a |
23 | secured drug room or secured drug cart under the supervision |
24 | of designated personnel who are responsible for the drugs in |
25 | that correctional facility. |
26 | (7) The drug has no fewer than 90 days before its |
27 | expiration date. |
28 | (8) A pharmacist at the vendor pharmacy determines by |
29 | visual inspection that the returned products are not |
30 | adulterated or misbranded. |
|
1 | (9) A pharmacist at the vendor pharmacy using the |
2 | pharmacist's professional judgment determines that: |
3 | (i) The conditions under which the drug has been |
4 | delivered, stored and handled before and during its |
5 | return to the pharmacy have preserved proper integrity, |
6 | stability and labeling of the drug. |
7 | (ii) The drug labeling or packaging has not been |
8 | altered or defaced. |
9 | (iii) The drug name, strength, manufacturer |
10 | identifier, lot and expiration date are retrievable. |
11 | Section 4. Vendor pharmacy redispensing. |
12 | The vendor pharmacy to which drug products are returned may |
13 | redispense a drug properly returned under section 3, provided |
14 | that: |
15 | (1) The drugs are returned directly from the |
16 | correctional facility to the vendor pharmacy. |
17 | (2) The drugs returned to the vendor pharmacy are stored |
18 | separately from the rest of the pharmacy's stock. |
19 | (3) The redispensing is in compliance with the Food and |
20 | Drug Administration, the United States Pharmacopeia and the |
21 | vendor pharmacy's policies and procedures. |
22 | (4) The vendor pharmacy records receipt of the drug, |
23 | including: |
24 | (i) The date the drug was received. |
25 | (ii) The quantity of the drug. |
26 | (iii) The lot number of the drug. |
27 | (iv) The expiration date of the drug. |
28 | (5) Information recorded under this section is |
29 | maintained for at least two years from the date the drug is |
30 | redispensed. |
|
1 | (6) The unit dose package, unit of issue of originally |
2 | sealed container stays intact with drug name, strength, |
3 | manufacturer identifier, lot and expiration date and is not |
4 | emptied from the returned unit dose, unit of issue or |
5 | original container for repacking. |
6 | (7) The name of any patient for whom the drug was |
7 | previously prescribed is removed prior to redispensing. |
8 | (8) The drug remains in the original container or |
9 | package and that before redispensing, the label meets the |
10 | requirements of the State Board of Pharmacy's rules and |
11 | regulations. |
12 | Section 5. Credit for redispensing. |
13 | The vendor pharmacy, to which drug products are returned, |
14 | shall credit the correctional facility for the unused drugs that |
15 | are permitted to be restocked for redispensing at a rate |
16 | determined by the vendor pharmacy and the correctional facility. |
17 | Section 6. Disposal of unacceptable returned drugs. |
18 | Returned drugs that do not meet all the requirements of |
19 | section 3 shall be deemed unacceptable for redispensing and |
20 | processed for disposal. Drugs deemed unacceptable for |
21 | redispensing shall be sent to a destruction agency, reverse |
22 | distributor, manufacturer, original wholesaler or other approved |
23 | entity. |
24 | Section 7. Unprofessional conduct. |
25 | (1) A pharmacist who is authorized under this act to |
26 | redispense a drug and who properly relabels and repackages |
27 | the drug shall not be deemed to have engaged in |
28 | unprofessional conduct under section 5 of the act of |
29 | September 27, 1961 (P.L.1700, No.699), known as the Pharmacy |
30 | Act. |
|
1 | (2) A pharmacist who fails to comply with the provisions |
2 | of this act may be subject to discipline under the Pharmacy |
3 | Act. |
4 | (3) A pharmacy that fails to comply with the provisions |
5 | of this act may be subject to discipline under the Pharmacy |
6 | Act. |
7 | Section 8. Effective date. |
8 | This act shall take effect immediately. |
|