THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY HORNAMAN, CURRY, K. BOYLE, CALTAGIRONE, DAVIS, EVERETT, FABRIZIO, FREEMAN, GEORGE, HARKINS, HESS, JAMES, JOSEPHS, KORTZ, MULLERY, M. O'BRIEN, NEILSON, SAMUELSON, VITALI, VULAKOVICH, WATERS AND WILLIAMS, JUNE 12, 2012

REFERRED TO COMMITTEE ON HEALTH, JUNE 12, 2012  

AN ACT

Providing for the collection and disposal of leftover and

expired medicines and for penalties.

The General Assembly finds and declares that:

(1)  Pennsylvania citizens benefit from the authorized

use of prescription and nonprescription medicines. The proper

use of medicines helps to cure, treat and prevent diseases

and to prolong life.

(2)  Failure to properly dispose of leftover and expired

medicines can lead to the illegal possession and abuse of

medicines by children and others, possibly causing addiction,

poisonings, overdoses and other harmful health effects.

(3)  Disposing of medicines by flushing them down the

toilet or placing them in the garbage can lead to the

contamination of groundwater and other bodies of water,

contributing to degradation of the environment and harm to

humans, animals and aquatic life.

(4)  Pennsylvania residents need a safe method for

disposal of medicines through programs that provide

environmentally sound disposal of medicines with effective

controls against diversion.

(5)  The costs of properly collecting and disposing of

leftover and expired medicines should be included in the

manufacturer's business costs and the manufacturers of the

medicines are best positioned to efficiently develop and

operate programs for the safe and convenient collection and

disposal of unused medicines.

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

Pharmaceutical Stewardship 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:

"Controlled substance."  A drug, substance or immediate

precursor included in Schedules I through V of the act of April

14, 1972 (P.L.233, No.64), known as The Controlled Substance,

Drug, Device and Cosmetic Act.

"Covered drug."  As follows:

(1)  A lawfully obtained prescription drug and

nonprescription drug. The term includes both brand name and

generic drugs permitted to be accepted in accordance with

Federal and State law.

(2)  The term does not include:

(i)  Herbal-based remedies and homeopathic drugs,

products or remedies.

(ii)  Cosmetics, shampoos, sunscreens, toothpaste,

lip balm, antiperspirants or other personal care products

that are regulated as both cosmetics and proprietary

drugs under the Federal Food, Drug, and Cosmetic Act (52

Stat. 1040, 21 U.S.C. § 301 et seq.).

(iii)  Drugs for which a manufacturer provides a

take-back program as part of the managed risk evaluation

and mitigation strategy under 21 U.S.C. § 355-1 (relating

to risk evaluation and mitigation strategies).

(iv)  Drugs that are biological products as defined

in 21 CFR 600.3(h) (relating to definitions) as it exists

on the effective date of this section if the manufacturer

already provides a take-back program.

(v)  Pet pesticides contained in pet collars, powders

or shampoos.

"Department."  The Department of Health of the Commonwealth.

"Drug."  Any of the following:

(1)  Substances recognized in the official United States

Pharmacopeia, or official National Formulary, or any

supplement to either of them.

(2)  Substances intended for use in the diagnosis, cure,

mitigation, treatment or prevention of disease in man or

other animals.

(3)  Substances, other than food, intended to affect the

structure or any function of the human body or other animal

body.

(4)  Substances intended for use as a component of any

article specified under paragraphs (1), (2) and (3).

"Generic drug."  A drug that is chemically identical or

bioequivalent to a brand name drug in dosage form, safety,

strength, route of administration, quality, performance

characteristics and intended use, though inactive ingredients

may vary.

"Mail-back program."  A system whereby residential sources of

unwanted covered drugs obtain prepaid and preaddressed mailing

envelopes for shipment to an entity that will dispose of them

safely and legally.

"Manufacture."  As follows:

(1)  Any of the following:

(i)  The production, preparation, propagation,

compounding, conversion or processing of a drug or

controlled substance.

(ii)  The packaging or repackaging of a substance

under subparagraph (i).

(iii)  The labeling or relabeling of the commercial

container of a substance under subparagraph (i).

(2)  The term does not include the activities of a

practitioner who, as an incident to his administration or

dispensing the substance in the course of his professional

practice, prepares, compounds, packages or labels the

substance.

"Manufacturer."  A person lawfully authorized to manufacture

a drug or controlled substance.

"Nonproprietary drug."  A drug or controlled substance

required by any applicable Federal or State law to be dispensed

only by prescription.

"Pharmaceutical stewardship program."  A program operated by

a manufacturer, group of manufacturers or an association for the

collection, transportation and disposal of unwanted covered

drugs from residential sources that is financed by the

manufacturers of those products.

"Proprietary drug."  Nonprescription, nonnarcotic medicines

or drugs which may be sold without a prescription and which are

prepackaged for use by the consumer and labeled in accordance

with Federal and State requirements.

"Residential sources."  As follows:

(1)  Single and multiple-family residences and locations

where household drugs are unused, unwanted, disposed or

abandoned.

(2)  The term does not include drugs from hospitals,

clinics, pharmacies, airport security, drug seizures by law

enforcement, businesses or other nonresidential or business

sources.

"Ultimate user."  A person who lawfully possesses a drug or

controlled substance for his own use or for the use of a member

of his household or for administering to an animal in his care.

"Unwanted covered drug."  Any covered drug no longer wanted

by its ultimate user or that has been abandoned, discarded or is

intended to be discarded by its ultimate user.

Section 3.  Pharmaceutical stewardship program.

(a)  Participation required.--Beginning January 1, 2014, any

manufacturer offering a covered drug for sale in this

Commonwealth must operate or participate in an approved

pharmaceutical stewardship program prior to offering covered

drugs for sale in Pennsylvania.

(b)  Submittal.--After January 1, 2014, any manufacturer who

intends to offer covered drugs for sale in this Commonwealth

must have received an approval to operate a pharmaceutical

stewardship program plan from the department or provide evidence

of having joined an existing pharmaceutical stewardship program

to the department at least 45 days prior to the manufacturer's

initial offer of sale of covered drugs.

(c)  Program requirements.--A pharmaceutical stewardship

program plan must meet or include all of the following:

(1)  Implementation of the pharmaceutical stewardship

program without charging a line item fee for the cost of the

program visible to the consumer at the time of sale of the

covered drugs or at the time the unwanted covered drugs are

delivered or collected for disposal from residential sources.

(2)  A description of a proposed collection system which

shall include all of the following:

(i)  (A)  Except as provided under clause (B), at

least one collection site in each county. At least

one of the collection sites in each county shall have

Federal authorization to collect lawfully obtained

controlled substances.

(B)  Counties with the following populations

based on the most recent Federal decennial census

shall have collection sites as follows:

(I)  A county with a population of 100,001 to

300,000 shall have at least two collection sites.

(II)  A county with a population of 300,001

to 1,000,000 shall have at least three collection

sites.

(III)  A county with a population in excess

of 1,000,000 shall have at least four collection

sites.

(C)  Except for a county of the first class, a

collection site under this subparagraph may not be

established in the same municipality as a collection

site under subparagraph (ii).

(ii)  At least one collection site in every

municipality with a population over 50,000 in the most

recent Federal decennial census. Collection sites

established under subparagraph (i) may not be used to

meet the requirements under this subparagraph.

(iii)  A mail-back program for unwanted covered

drugs. Envelopes for the program must be made available

at each collection site and to any pharmacy in the county

interested in providing envelopes to their customers.

(3)  A handling and disposal system, including:

(i)  Identification of and contact information for

disposal facilities and other entities to be used by the

program to collect and destroy the unwanted covered

drugs.

(ii)  The policies and procedures to be followed by

persons handling and transporting unwanted covered drugs

collected under the pharmaceutical stewardship program.

(iii)  A description of how the collected unwanted

covered drugs are tracked through to final disposal and

how safety and security is maintained.

(iv)  Final disposal or reuse technologies that

provide superior environmental and human health

protection compared with current disposal technologies

for unwanted covered drugs, if approved by the department

upon petition. The department may not approve the use of

an alternative proposed technology unless the petitioners

have presented clear and convincing evidence that the

technology's performance under field conditions provides

equivalent protection in each and superior protection in

one or more of the following areas:

(A)  Monitoring emissions or waste.

(B)  Worker health and safety.

(C)  Air, water or land emissions contributing to

persistent, bioaccumulative and toxic pollution.

(D)  Overall impact to the environment and human

health.

(v)  Separation of unwanted covered drugs from their

original containers, if appropriate, prior to disposal.

(4)  A list of all entities participating in the

collection, handling and disposal proposed in the

pharmaceutical stewardship program and the entities' contact

information.

(5)  Certification that the pharmaceutical stewardship

program will accept all unwanted covered drugs, including

unwanted covered drugs from other manufacturers.

(6)  An education and outreach program that shall

include:

(i)  A toll-free phone number and a website which

shall provide information on the pharmaceutical

stewardship program and a list of all collections sites

and allow a person to request that a mail-back program

envelope be mailed to them.

(ii)  Printed brochures and posters describing where

and how to return unwanted covered drugs provided at no

cost to pharmacies, health care facilities and other

interested parties.

(7)  Performance goals, including recovery goals

expressed as pounds of unwanted covered drugs disposed of per

capita and an explanation of how the recovery goals have been

set to recover a significant percentage of unwanted covered

drugs relative to the quantity of unwanted covered drugs that

may be available for disposal.

(8)  Operation of the pharmaceutical stewardship program

in accordance with this act and other applicable Federal and

State laws.

(9)  A specific date for implementation.

(d)  Secure and Responsible Drug Disposal Act of 2010.--

Within 180 days after promulgation of Federal regulations

authorized under the Secure and Responsible Drug Disposal Act of

2010 (P.L. 111-273), each pharmaceutical stewardship program

shall submit an updated plan reflecting any necessary changes

required by the Federal regulations.

Section 4.  Department review and approval.

(a)  Approval required.--No manufacturer or other entity may

collect unwanted covered drugs until it has received written

approval or renewal of its pharmaceutical stewardship program

plan from the department.

(b)  Compliance.--Within 90 days after receipt of a

pharmaceutical stewardship program plan, the department shall

determine whether it complies with this act. If it is deemed in

compliance with this act, the department shall notify the

applicant of its approval in writing. If the pharmaceutical

stewardship program plan is rejected, the department shall

notify the applicant in writing of its reasons for rejection.

(c)  Review.--

(1)  A manufacturer or other entity operating a

pharmaceutical stewardship program shall conduct an internal

evaluation of its program which shall be submitted to the

department as follows:

(i)  Two years after implementation of the plan.

(ii)  Five years after implementation of the plan,

and every five years thereafter.

(2)  The department shall review the internal evaluations

submitted under this subsection and shall grant or deny

approval for the continued operation of the program in

accordance with the procedures under subsection (b).

(d)  Substantive changes.--Any substantive changes to a

pharmaceutical stewardship program plan must be approved by the

department in writing.

Section 5.  Report.

On or before April 1, 2015, and each April thereafter, a

pharmaceutical stewardship program under section 3(b) must

prepare and submit an annual report describing the program's

activities during the previous calendar year to the department.

The report must include all of the following:

(1)  A list of manufacturers participating in the

pharmaceutical stewardship program.

(2)  The amount, by weight, of unwanted covered drugs

collected at each site and the total amount by weight

collected by a mail-back program.

(3)  A list of the collection sites provided in each

county, including the location of each collection site and

locations where envelopes for a mail-back program are

provided.

(4)  The name and location of disposal facilities at

which unwanted covered drugs were disposed of and the weight

of unwanted covered drugs disposed of at each facility.

(5)  If packaging was separated from the unwanted covered

drugs prior to disposal, the amount and percentage of

packaging recycled and the name and location of the material

recovery facility to which it was delivered.

(6)  Whether policies and procedures for collecting,

transporting and disposing of unwanted covered drugs, as

established in the pharmaceutical stewardship program plan,

were followed during the reporting period and a description

of any noncompliance.

(7)  Whether any safety or security problems occurred

during collection, transportation or disposal of unwanted

covered drugs during the reporting period and, if so, what

changes have or will be made to policies, procedures or

tracking mechanisms to alleviate the problem and to improve

safety and security.

(8)  A description of public education and outreach

activities implemented during the reporting period, including

the methodology used to evaluate the outreach and program

activities.

(9)  Any other information that the agency may reasonably

require.

Section 6.  Enforcement.

(a)  Penalty for nonimplementation.--If an approved

pharmaceutical stewardship program plan is not fully implemented

as follows, the department shall assess the following penalties

for each calendar day along with written notification to each

manufacturer associated with the pharmaceutical stewardship

program plan:

(1)  If full implementation has not occurred within 30

days of the start date contained in the pharmaceutical

stewardship program plan, the department shall assess a

penalty of $5,000 against the manufacturer or entity that

developed the pharmaceutical stewardship program under

section 3(b).

(2)  If full implementation has not occurred within 60

days of the start date contained in the pharmaceutical

stewardship program plan, the department shall assess a

penalty of $10,000 against the manufacturer or entity that

developed the pharmaceutical stewardship program under

section 3(b).

(b)  Penalty for noncompliance.--If the department finds that

a pharmaceutical stewardship program is not in compliance with

its approved plan, the department must notify in writing each

manufacturer in the pharmaceutical stewardship program of the

violation and allow the manufacturer or entity operating the

pharmaceutical stewardship program 30 days to correct the

noncompliance. After 30 days, the manufacturer or entity

operating the pharmaceutical stewardship program under section

3(b) shall be assessed a penalty of $5,000 for the first

violation and $10,000 for each subsequent violation. Subsequent

violations shall occur after each ten days of noncompliance

under this subsection.

(c)  Penalty for nonparticipation.--

(1)  Upon first determining that a manufacturer is

offering a covered drug for sale in this Commonwealth but is

not participating in a pharmaceutical stewardship program

approved by the agency, the department shall send the

manufacturer a written warning that the manufacturer is in

violation of this act.

(2)  A manufacturer not participating in a pharmaceutical

stewardship program approved by the department whose covered

drug continues to be sold in this Commonwealth 60 days after

receiving a written warning from the department shall be

assessed a penalty of $10,000 for each calendar day that the

violation continues.

Section 20.  Effective date.

This act shall take effect in 90 days.