PRINTER'S NO. 801
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
686
Session of
2015
INTRODUCED BY KORTZ, COHEN, STURLA, KOTIK, CALTAGIRONE, O'BRIEN,
DEASY, DAVIS, MURT, READSHAW, GIBBONS, ROZZI, KINSEY,
McNEILL, BOBACK, FABRIZIO, EVERETT AND THOMAS, MARCH 3, 2015
REFERRED TO COMMITTEE ON HEALTH, MARCH 3, 2015
AN ACT
Providing for the collection and disposal of leftover and
expired medicines and for penalties.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Findings.
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,
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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.
Section 2. Short title.
This act shall be known and may be cited as the
Pharmaceutical Stewardship Act.
Section 3. 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,
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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
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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
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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 4. Pharmaceutical stewardship program.
(a) Participation required.--Beginning January 1, 2016, 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, 2016, 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
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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
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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
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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 telephone number and an Internet
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
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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 5. 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
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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 6. Report.
On or before April 1, 2017, 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
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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 7. 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
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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 10 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
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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 8. Effective date.
This act shall take effect in 90 days.
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