Bill Text: PA SB1044 | 2009-2010 | Regular Session | Amended

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Bill Title: Providing for drug redistribution within correctional facilities.

Spectrum: Slight Partisan Bill (Republican 11-6)

Status: (Passed) 2010-07-09 - Act No. 59 [SB1044 Detail]

Download: Pennsylvania-2009-SB1044-Amended.html

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PRIOR PRINTER'S NO. 1336 PRINTER'S NO. 1618
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No. 1044 Session of2009
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
SENATOR GREENLEAF, JUDICIARY, AS AMENDED, JANUARY 26, 2010
AN ACT
Providing Amending Title 61 (Penal and Correctional <--
Institutions) of the Pennsylvania Consolidated Statutes,
providing for drug redistribution within correctional
facilities.
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 Correctional
Facilities Drug Redistribution 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:
"Correctional facility." A jail, prison, facility,
institution, group home, prerelease center, community
corrections center, parole center or any facility that houses a
a person convicted of a criminal offense, or awaiting trial,
sentencing or extradition in a criminal proceeding. The term
includes an institution, facility or unit operated by or for the
Department of Corrections. The term does not include any
facility or institution operated, supervised or licensed under
the act of June 13, 1967 (P.L.31, No.21), known as the Public
Welfare Code.
"Designated personnel." Correctional facility employees or
employees of a vendor for a correctional facility licensed by
the State Board of Medicine, State Board of Osteopathic
Medicine, State Board of Nursing or State Board of Pharmacy and
authorized by their scope of practice to administer drugs.
"Drug." Any medication prescribed by a licensed
practitioner, either patient specific or stock to a patient in a
correctional facility.
"Manufacturer." A company that produces a drug or a Federal
Drug Administration certified repacker who packages or
repackages a drug product for distribution.
"Manufacturer identifier." A manufacturer's name or product
National Drug Code number.
"Unit dose package." An individually sealed package that
contains a single dose drug with the drug name, strength,
manufacturer identifier, lot number and expiration date of the
drug on the package.
"Unit of issue package." A package that includes multiple
unit dose packages of the same drug.
"Vendor pharmacy." A licensed pharmacy that packages,
repackages or prepares a manufacturer-sealed container, unit
dose package or unit of issue package for delivery to a
correctional facility.
Section 3. Return to and redispensing by vendor pharmacy.
A drug that is issued to a correctional facility and has left
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the control of a pharmacist at a vendor pharmacy may be returned
to its vendor pharmacy for the purpose of redispensing that drug
to fill other prescriptions for other correctional facilities
only if the following requirements are met:
(1) The drug is not a Schedule I, II, III, IV or V
controlled substance as specified in the act of April 14,
1972 (P.L.233, No.64), known as The Controlled Substance,
Drug, Device and Cosmetic Act.
(2) The drug is returned to its vendor pharmacy in
accordance with the vendor pharmacy's written policies and
procedures that comply with section 4 and the State Board of
Pharmacy's rules and regulations in regard to delivery,
storage, labeling and reissuing of the drug.
(3) The drug is returned to the vendor pharmacy unopened
and still sealed in the unit dose package, unit of issue
package, bottle or manufacturer's package.
(4) Each returned unit dose package, unit of issue
package or manufacturer's package retains the drug name,
strength, manufacturer identifier, lot and expiration date as
originally labeled by the pharmacy or manufacturer.
(5) The drug issued to the facility was at no time in
the possession or control of a patient.
(6) The drug remained in a controlled environment of a
secured drug room or secured drug cart under the supervision
of designated personnel who are responsible for the drugs in
that correctional facility.
(7) The drug has no fewer than 90 days before its
expiration date.
(8) A pharmacist at the vendor pharmacy determines by
visual inspection that the returned products are not
20090SB1044PN1618 - 3 -
adulterated or misbranded.
(9) A pharmacist at the vendor pharmacy using the
pharmacist's professional judgment determines that:
(i) The conditions under which the drug has been
delivered, stored and handled before and during its
return to the pharmacy have preserved proper integrity,
stability and labeling of the drug.
(ii) The drug labeling or packaging has not been
altered or defaced.
(iii) The drug name, strength, manufacturer
identifier, lot and expiration date are retrievable.
Section 4. Vendor pharmacy redispensing.
The vendor pharmacy to which drug products are returned may
redispense a drug properly returned under section 3, provided
that:
(1) The drugs are returned directly from the
correctional facility to the vendor pharmacy.
(2) The drugs returned to the vendor pharmacy are stored
separately from the rest of the pharmacy's stock.
(3) The redispensing is in compliance with the Food and
Drug Administration, the United States Pharmacopeia and the
vendor pharmacy's policies and procedures.
(4) The vendor pharmacy records receipt of the drug,
including:
(i) The date the drug was received.
(ii) The quantity of the drug.
(iii) The lot number of the drug.
(iv) The expiration date of the drug.
(5) Information recorded under this section is
maintained for at least two years from the date the drug is
20090SB1044PN1618 - 4 -
redispensed.
(6) The unit dose package, unit of issue of originally
sealed container stays intact with drug name, strength,
manufacturer identifier, lot and expiration date and is not
emptied from the returned unit dose, unit of issue or
original container for repacking.
(7) The name of any patient for whom the drug was
previously prescribed is removed prior to redispensing.
(8) The drug remains in the original container or
package and that before redispensing, the label meets the
requirements of the State Board of Pharmacy's rules and
regulations.
Section 5. Credit for redispensing.
The vendor pharmacy, to which drug products are returned,
shall credit the correctional facility for the unused drugs that
are permitted to be restocked for redispensing at a rate
determined by the vendor pharmacy and the correctional facility.
Section 6. Disposal of unacceptable returned drugs.
Returned drugs that do not meet all the requirements of
section 3 shall be deemed unacceptable for redispensing and
processed for disposal. Drugs deemed unacceptable for
redispensing shall be sent to a destruction agency, reverse
distributor, manufacturer, original wholesaler or other approved
entity.
Section 7. Unprofessional conduct.
(1) A pharmacist who is authorized under this act to
redispense a drug and who properly relabels and repackages
the drug shall not be deemed to have engaged in
unprofessional conduct under section 5 of the act of
September 27, 1961 (P.L.1700, No.699), known as the Pharmacy
20090SB1044PN1618 - 5 -
Act.
(2) A pharmacist who fails to comply with the provisions
of this act may be subject to discipline under the Pharmacy
Act.
(3) A pharmacy that fails to comply with the provisions
of this act may be subject to discipline under the Pharmacy
Act.
Section 8. Effective date.
This act shall take effect immediately.
Section 1. Chapter 11 of Title 61 of the Pennsylvania <--
Consolidated Statutes, added August 11, 2009 (P.L.147, No.33),
is amended by adding a subchapter to read:
SUBCHAPTER D
DRUG REDISTRIBUTION
Sec.
1171. Scope.
1172. Definitions.
1173. Return to and redispensing by vendor pharmacy.
1174. Vendor pharmacy redispensing.
1175. Credit for redispensing.
1176. Disposal of unacceptable returned drugs.
1177. Unprofessional conduct.
§ 1171. Scope.
This subchapter relates to correctional facility drug
redistribution.
§ 1172. Definitions.
The following words and phrases when used in this subchapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Correctional facility." A correctional institution, group
20090SB1044PN1618 - 6 -
home, prerelease center, community corrections center, parole
center or any facility that houses a person convicted of a
criminal offense, or awaiting trial, sentencing or extradition
in a criminal proceeding. The term does not include any facility
or institution operated, supervised or licensed under the act of
June 13, 1967 (P.L.31, No.21), known as the Public Welfare Code.
"Designated personnel." Correctional facility employees or
employees of a vendor for a correctional facility licensed by
the State Board of Medicine, State Board of Osteopathic
Medicine, State Board of Nursing or State Board of Pharmacy and
authorized by their scope of practice to administer drugs.
"Drug." Any medication prescribed by a licensed
practitioner, either patient specific or stock, to a patient in
a correctional facility.
"Manufacturer." A company that produces a drug or a Federal
Drug Administration certified repacker who packages or
repackages a drug product for distribution.
"Manufacturer identifier." A manufacturer's name or product
National Drug Code number.
"Unit dose package." An individually sealed package that
contains a single dose drug with the drug name, strength,
manufacturer identifier, lot number and expiration date of the
drug on the package.
"Unit of issue package." A package that includes multiple
unit dose packages of the same drug.
"Vendor pharmacy." A licensed pharmacy that packages,
repackages or prepares a manufacturer-sealed container, unit
dose package or unit of issue package for delivery to a
correctional facility.
§ 1173. Return to and redispensing by vendor pharmacy.
20090SB1044PN1618 - 7 -
A drug that is issued to a correctional facility and has left
the control of a pharmacist at a vendor pharmacy may be returned
to its vendor pharmacy for the purpose of redispensing that drug
to fill other prescriptions for other correctional facilities
only if the following requirements are met:
(1) The drug is not a Schedule I, II, III, IV or V
controlled substance as specified in the act of April 14,
1972 (P.L.233, No.64), known as The Controlled Substance,
Drug, Device and Cosmetic Act.
(2) The drug is returned to its vendor pharmacy in
accordance with the vendor pharmacy's written policies and
procedures that comply with section 1174 (relating to vendor
pharmacy redispensing) and the State Board of Pharmacy's
rules and regulations in regard to delivery, storage,
labeling and reissuing of the drug.
(3) The drug is returned to the vendor pharmacy unopened
and still sealed in the unit dose package, unit of issue
package, bottle or manufacturer's package.
(4) Each returned unit dose package, unit of issue
package, bottle or manufacturer's package retains the drug
name, strength, manufacturer identifier, lot and expiration
date as originally labeled by the pharmacy or manufacturer.
(5) The drug issued to the facility was at no time in
the possession or control of a patient.
(6) The drug remained in a controlled environment of a
secured drug room or secured drug cart under the supervision
of designated personnel who are responsible for the drugs in
that correctional facility.
(7) The drug has no fewer than 90 days before its
expiration date.
20090SB1044PN1618 - 8 -
(8) A pharmacist at the vendor pharmacy determines by
visual inspection that the returned products are not
adulterated or misbranded.
(9) A pharmacist at the vendor pharmacy using the
pharmacist's professional judgment determines that:
(i) The conditions under which the drug has been
delivered, stored and handled before and during its
return to the pharmacy have preserved proper integrity,
stability and labeling of the drug.
(ii) The drug labeling or packaging has not been
altered or defaced.
(iii) The drug name, strength, manufacturer
identifier, lot and expiration date are retrievable.
§ 1174. Vendor pharmacy redispensing.
The vendor pharmacy to which drug products are returned may
redispense a drug properly returned under section 1173 (relating
to return to and redispensing by vendor pharmacy), provided
that:
(1) The drugs are returned directly from the
correctional facility to the vendor pharmacy.
(2) The drugs returned to the vendor pharmacy are stored
separately from the rest of the pharmacy's stock.
(3) The redispensing is in compliance with the United
States Pharmacopeia and the vendor pharmacy's policies and
procedures.
(4) The vendor pharmacy records receipt of the drug,
including:
(i) The date the drug was received.
(ii) The quantity of the drug.
(iii) The lot number of the drug.
20090SB1044PN1618 - 9 -
(iv) The expiration date of the drug.
(5) Information recorded under this section is
maintained for at least two years from the date the drug is
redispensed.
(6) The unit dose package, unit of issue or originally
sealed container stays intact with drug name, strength,
manufacturer identifier, lot and expiration date and is not
emptied from the returned unit dose, unit of issue or
original container for repacking.
(7) The name of any patient for whom the drug was
previously prescribed is removed prior to redispensing.
(8) The drug remains in the original container or
package and before redispensing, the vendor pharmacy ensures
that the label meets the requirements of the State Board of
Pharmacy's rules and regulations.
§ 1175. Credit for redispensing.
The vendor pharmacy, to which drug products are returned,
shall credit the correctional facility for the unused drugs that
are permitted to be restocked for redispensing at a rate
determined by the vendor pharmacy and the correctional facility.
§ 1176. Disposal of unacceptable returned drugs.
Returned drugs that do not meet all the requirements of
section 1173 (relating to return to and redispensing by vendor
pharmacy) shall be deemed unacceptable for redispensing and
processed for disposal. Drugs deemed unacceptable for
redispensing shall be sent to a destruction agency, reverse
distributor, manufacturer, original wholesaler or other approved
entity.
§ 1177. Unprofessional conduct.
(1) A pharmacist who is authorized under this subchapter
20090SB1044PN1618 - 10 -
to redispense a drug and who properly relabels and repackages
the drug shall not be deemed to have engaged in
unprofessional conduct under section 5 of the act of
September 27, 1961 (P.L.1700, No.699), known as the Pharmacy
Act.
(2) A pharmacist who fails to comply with the provisions
of this subchapter may be subject to discipline under the
Pharmacy Act.
(3) A pharmacy that fails to comply with the provisions
of this subchapter may be subject to discipline under the
Pharmacy Act.
Section 2. This act shall take effect immediately.
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