1Providing for the collection and disposal of leftover and
2expired medicines and for penalties.

3The General Assembly finds and declares that:

4(1) Pennsylvania citizens benefit from the authorized
5use of prescription and nonprescription medicines. The proper
6use of medicines helps to cure, treat and prevent diseases
7and to prolong life.

8(2) Failure to properly dispose of leftover and expired
9medicines can lead to the illegal possession and abuse of
10medicines by children and others, possibly causing addiction,
11poisonings, overdoses and other harmful health effects.

12(3) Disposing of medicines by flushing them down the
13toilet or placing them in the garbage can lead to the
14contamination of groundwater and other bodies of water,
15contributing to degradation of the environment and harm to
16humans, animals and aquatic life.

17(4) Pennsylvania residents need a safe method for
18disposal of medicines through programs that provide

1environmentally sound disposal of medicines with effective
2controls against diversion.

3(5) The costs of properly collecting and disposing of
4leftover and expired medicines should be included in the
5manufacturer's business costs and the manufacturers of the
6medicines are best positioned to efficiently develop and
7operate programs for the safe and convenient collection and
8disposal of unused medicines.

9The General Assembly of the Commonwealth of Pennsylvania
10hereby enacts as follows:

11Section 1. Short title.

12This act shall be known and may be cited as the
13Pharmaceutical Stewardship Act.

14Section 2. Definitions.

15The following words and phrases when used in this act shall
16have the meanings given to them in this section unless the
17context clearly indicates otherwise:

18"Controlled substance." A drug, substance or immediate
19precursor included in Schedules I through V of the act of April
2014, 1972 (P.L.233, No.64), known as The Controlled Substance,
21Drug, Device and Cosmetic Act.

22"Covered drug." As follows:

23(1) A lawfully obtained prescription drug and
24nonprescription drug. The term includes both brand name and
25generic drugs permitted to be accepted in accordance with
26Federal and State law.

27(2) The term does not include:

28(i) Herbal-based remedies and homeopathic drugs,
29products or remedies.

30(ii) Cosmetics, shampoos, sunscreens, toothpaste,

1lip balm, antiperspirants or other personal care products
2that are regulated as both cosmetics and proprietary
3drugs under the Federal Food, Drug, and Cosmetic Act (52
4Stat. 1040, 21 U.S.C. § 301 et seq.).

5(iii) Drugs for which a manufacturer provides a
6take-back program as part of the managed risk evaluation
7and mitigation strategy under 21 U.S.C. § 355-1 (relating
8to risk evaluation and mitigation strategies).

9(iv) Drugs that are biological products as defined
10in 21 CFR 600.3(h) (relating to definitions) as it exists
11on the effective date of this section if the manufacturer
12already provides a take-back program.

13(v) Pet pesticides contained in pet collars, powders
14or shampoos.

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

16"Drug." Any of the following:

17(1) Substances recognized in the official United States
18Pharmacopeia, or official National Formulary, or any
19supplement to either of them.

20(2) Substances intended for use in the diagnosis, cure,
21mitigation, treatment or prevention of disease in man or
22other animals.

23(3) Substances, other than food, intended to affect the
24structure or any function of the human body or other animal
25body.

26(4) Substances intended for use as a component of any
27article specified under paragraphs (1), (2) and (3).

28"Generic drug." A drug that is chemically identical or
29bioequivalent to a brand name drug in dosage form, safety,
30strength, route of administration, quality, performance

1characteristics and intended use, though inactive ingredients
2may vary.

3"Mail-back program." A system whereby residential sources of
4unwanted covered drugs obtain prepaid and preaddressed mailing
5envelopes for shipment to an entity that will dispose of them
6safely and legally.

7"Manufacture." As follows:

8(1) Any of the following:

9(i) The production, preparation, propagation,
10compounding, conversion or processing of a drug or
11controlled substance.

12(ii) The packaging or repackaging of a substance
13under subparagraph (i).

14(iii) The labeling or relabeling of the commercial
15container of a substance under subparagraph (i).

16(2) The term does not include the activities of a
17practitioner who, as an incident to his administration or
18dispensing the substance in the course of his professional
19practice, prepares, compounds, packages or labels the
20substance.

21"Manufacturer." A person lawfully authorized to manufacture
22a drug or controlled substance.

23"Nonproprietary drug." A drug or controlled substance
24required by any applicable Federal or State law to be dispensed
25only by prescription.

26"Pharmaceutical stewardship program." A program operated by
27a manufacturer, group of manufacturers or an association for the
28collection, transportation and disposal of unwanted covered
29drugs from residential sources that is financed by the
30manufacturers of those products.

1"Proprietary drug." Nonprescription, nonnarcotic medicines
2or drugs which may be sold without a prescription and which are
3prepackaged for use by the consumer and labeled in accordance
4with Federal and State requirements.

5"Residential sources." As follows:

6(1) Single and multiple-family residences and locations
7where household drugs are unused, unwanted, disposed or
8abandoned.

9(2) The term does not include drugs from hospitals,
10clinics, pharmacies, airport security, drug seizures by law
11enforcement, businesses or other nonresidential or business
12sources.

13"Ultimate user." A person who lawfully possesses a drug or
14controlled substance for his own use or for the use of a member
15of his household or for administering to an animal in his care.

16"Unwanted covered drug." Any covered drug no longer wanted
17by its ultimate user or that has been abandoned, discarded or is
18intended to be discarded by its ultimate user.

19Section 3. Pharmaceutical stewardship program.

20(a) Participation required.--Beginning January 1, 2015, any
21manufacturer offering a covered drug for sale in this
22Commonwealth must operate or participate in an approved
23pharmaceutical stewardship program prior to offering covered
24drugs for sale in Pennsylvania.

25(b) Submittal.--After January 1, 2015, any manufacturer who
26intends to offer covered drugs for sale in this Commonwealth
27must have received an approval to operate a pharmaceutical
28stewardship program plan from the department or provide evidence
29of having joined an existing pharmaceutical stewardship program
30to the department at least 45 days prior to the manufacturer's

1initial offer of sale of covered drugs.

2(c) Program requirements.--A pharmaceutical stewardship
3program plan must meet or include all of the following:

4(1) Implementation of the pharmaceutical stewardship
5program without charging a line item fee for the cost of the
6program visible to the consumer at the time of sale of the
7covered drugs or at the time the unwanted covered drugs are
8delivered or collected for disposal from residential sources.

9(2) A description of a proposed collection system which
10shall include all of the following:

11(i) (A) Except as provided under clause (B), at
12least one collection site in each county. At least
13one of the collection sites in each county shall have
14Federal authorization to collect lawfully obtained
15controlled substances.

16(B) Counties with the following populations
17based on the most recent Federal decennial census
18shall have collection sites as follows:

19(I) A county with a population of 100,001 to
20300,000 shall have at least two collection sites.

21(II) A county with a population of 300,001
22to 1,000,000 shall have at least three collection
23sites.

24(III) A county with a population in excess
25of 1,000,000 shall have at least four collection
26sites.

27(C) Except for a county of the first class, a
28collection site under this subparagraph may not be
29established in the same municipality as a collection
30site under subparagraph (ii).

1(ii) At least one collection site in every
2municipality with a population over 50,000 in the most
3recent Federal decennial census. Collection sites
4established under subparagraph (i) may not be used to
5meet the requirements under this subparagraph.

6(iii) A mail-back program for unwanted covered
7drugs. Envelopes for the program must be made available
8at each collection site and to any pharmacy in the county
9interested in providing envelopes to their customers.

10(3) A handling and disposal system, including:

11(i) Identification of and contact information for
12disposal facilities and other entities to be used by the
13program to collect and destroy the unwanted covered
14drugs.

15(ii) The policies and procedures to be followed by
16persons handling and transporting unwanted covered drugs
17collected under the pharmaceutical stewardship program.

18(iii) A description of how the collected unwanted
19covered drugs are tracked through to final disposal and
20how safety and security is maintained.

21(iv) Final disposal or reuse technologies that
22provide superior environmental and human health
23protection compared with current disposal technologies
24for unwanted covered drugs, if approved by the department
25upon petition. The department may not approve the use of
26an alternative proposed technology unless the petitioners
27have presented clear and convincing evidence that the
28technology's performance under field conditions provides
29equivalent protection in each and superior protection in
30one or more of the following areas:

1(A) Monitoring emissions or waste.

2(B) Worker health and safety.

3(C) Air, water or land emissions contributing to
4persistent, bioaccumulative and toxic pollution.

5(D) Overall impact to the environment and human
6health.

7(v) Separation of unwanted covered drugs from their
8original containers, if appropriate, prior to disposal.

9(4) A list of all entities participating in the
10collection, handling and disposal proposed in the
11pharmaceutical stewardship program and the entities' contact
12information.

13(5) Certification that the pharmaceutical stewardship
14program will accept all unwanted covered drugs, including
15unwanted covered drugs from other manufacturers.

16(6) An education and outreach program that shall
17include:

18(i) A toll-free phone number and a website which
19shall provide information on the pharmaceutical
20stewardship program and a list of all collections sites
21and allow a person to request that a mail-back program
22envelope be mailed to them.

23(ii) Printed brochures and posters describing where
24and how to return unwanted covered drugs provided at no
25cost to pharmacies, health care facilities and other
26interested parties.

27(7) Performance goals, including recovery goals
28expressed as pounds of unwanted covered drugs disposed of per
29capita and an explanation of how the recovery goals have been
30set to recover a significant percentage of unwanted covered

1drugs relative to the quantity of unwanted covered drugs that
2may be available for disposal.

3(8) Operation of the pharmaceutical stewardship program
4in accordance with this act and other applicable Federal and
5State laws.

6(9) A specific date for implementation.

7(d) Secure and Responsible Drug Disposal Act of 2010.--
8Within 180 days after promulgation of Federal regulations
9authorized under the Secure and Responsible Drug Disposal Act of
102010 (P.L. 111-273), each pharmaceutical stewardship program
11shall submit an updated plan reflecting any necessary changes
12required by the Federal regulations.

13Section 4. Department review and approval.

14(a) Approval required.--No manufacturer or other entity may
15collect unwanted covered drugs until it has received written
16approval or renewal of its pharmaceutical stewardship program
17plan from the department.

18(b) Compliance.--Within 90 days after receipt of a
19pharmaceutical stewardship program plan, the department shall
20determine whether it complies with this act. If it is deemed in
21compliance with this act, the department shall notify the
22applicant of its approval in writing. If the pharmaceutical
23stewardship program plan is rejected, the department shall
24notify the applicant in writing of its reasons for rejection.

25(c) Review.--

26(1) A manufacturer or other entity operating a
27pharmaceutical stewardship program shall conduct an internal
28evaluation of its program which shall be submitted to the
29department as follows:

30(i) Two years after implementation of the plan.

1(ii) Five years after implementation of the plan,
2and every five years thereafter.

3(2) The department shall review the internal evaluations
4submitted under this subsection and shall grant or deny
5approval for the continued operation of the program in
6accordance with the procedures under subsection (b).

7(d) Substantive changes.--Any substantive changes to a
8pharmaceutical stewardship program plan must be approved by the
9department in writing.

10Section 5. Report.

11On or before April 1, 2016, and each April thereafter, a
12pharmaceutical stewardship program under section 3(b) must
13prepare and submit an annual report describing the program's
14activities during the previous calendar year to the department.
15The report must include all of the following:

16(1) A list of manufacturers participating in the
17pharmaceutical stewardship program.

18(2) The amount, by weight, of unwanted covered drugs
19collected at each site and the total amount by weight
20collected by a mail-back program.

21(3) A list of the collection sites provided in each
22county, including the location of each collection site and
23locations where envelopes for a mail-back program are
24provided.

25(4) The name and location of disposal facilities at
26which unwanted covered drugs were disposed of and the weight
27of unwanted covered drugs disposed of at each facility.

28(5) If packaging was separated from the unwanted covered
29drugs prior to disposal, the amount and percentage of
30packaging recycled and the name and location of the material

1recovery facility to which it was delivered.

2(6) Whether policies and procedures for collecting,
3transporting and disposing of unwanted covered drugs, as
4established in the pharmaceutical stewardship program plan,
5were followed during the reporting period and a description
6of any noncompliance.

7(7) Whether any safety or security problems occurred
8during collection, transportation or disposal of unwanted
9covered drugs during the reporting period and, if so, what
10changes have or will be made to policies, procedures or
11tracking mechanisms to alleviate the problem and to improve
12safety and security.

13(8) A description of public education and outreach
14activities implemented during the reporting period, including
15the methodology used to evaluate the outreach and program
16activities.

17(9) Any other information that the agency may reasonably
18require.

19Section 6. Enforcement.

20(a) Penalty for nonimplementation.--If an approved
21pharmaceutical stewardship program plan is not fully implemented
22as follows, the department shall assess the following penalties
23for each calendar day along with written notification to each
24manufacturer associated with the pharmaceutical stewardship
25program plan:

26(1) If full implementation has not occurred within 30
27days of the start date contained in the pharmaceutical
28stewardship program plan, the department shall assess a
29penalty of $5,000 against the manufacturer or entity that
30developed the pharmaceutical stewardship program under

1section 3(b).

2(2) If full implementation has not occurred within 60
3days of the start date contained in the pharmaceutical
4stewardship program plan, the department shall assess a
5penalty of $10,000 against the manufacturer or entity that
6developed the pharmaceutical stewardship program under
7section 3(b).

8(b) Penalty for noncompliance.--If the department finds that
9a pharmaceutical stewardship program is not in compliance with
10its approved plan, the department must notify in writing each
11manufacturer in the pharmaceutical stewardship program of the
12violation and allow the manufacturer or entity operating the
13pharmaceutical stewardship program 30 days to correct the
14noncompliance. After 30 days, the manufacturer or entity
15operating the pharmaceutical stewardship program under section
163(b) shall be assessed a penalty of $5,000 for the first
17violation and $10,000 for each subsequent violation. Subsequent
18violations shall occur after each ten days of noncompliance
19under this subsection.

20(c) Penalty for nonparticipation.--

21(1) Upon first determining that a manufacturer is
22offering a covered drug for sale in this Commonwealth but is
23not participating in a pharmaceutical stewardship program
24approved by the agency, the department shall send the
25manufacturer a written warning that the manufacturer is in
26violation of this act.

27(2) A manufacturer not participating in a pharmaceutical
28stewardship program approved by the department whose covered
29drug continues to be sold in this Commonwealth 60 days after
30receiving a written warning from the department shall be

1assessed a penalty of $10,000 for each calendar day that the
2violation continues.

3Section 20. Effective date.

4This act shall take effect in 90 days.