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| THE GENERAL ASSEMBLY OF PENNSYLVANIA |
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| HOUSE BILL |
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| 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 |
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| REFERRED TO COMMITTEE ON HEALTH, JUNE 12, 2012 |
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| AN ACT |
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1 | Providing for the collection and disposal of leftover and |
2 | expired medicines and for penalties. |
3 | The General Assembly finds and declares that: |
4 | (1) Pennsylvania citizens benefit from the authorized |
5 | use of prescription and nonprescription medicines. The proper |
6 | use of medicines helps to cure, treat and prevent diseases |
7 | and to prolong life. |
8 | (2) Failure to properly dispose of leftover and expired |
9 | medicines can lead to the illegal possession and abuse of |
10 | medicines by children and others, possibly causing addiction, |
11 | poisonings, overdoses and other harmful health effects. |
12 | (3) Disposing of medicines by flushing them down the |
13 | toilet or placing them in the garbage can lead to the |
14 | contamination of groundwater and other bodies of water, |
15 | contributing to degradation of the environment and harm to |
16 | humans, animals and aquatic life. |
17 | (4) Pennsylvania residents need a safe method for |
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1 | disposal of medicines through programs that provide |
2 | environmentally sound disposal of medicines with effective |
3 | controls against diversion. |
4 | (5) The costs of properly collecting and disposing of |
5 | leftover and expired medicines should be included in the |
6 | manufacturer's business costs and the manufacturers of the |
7 | medicines are best positioned to efficiently develop and |
8 | operate programs for the safe and convenient collection and |
9 | disposal of unused medicines. |
10 | The General Assembly of the Commonwealth of Pennsylvania |
11 | hereby enacts as follows: |
12 | Section 1. Short title. |
13 | This act shall be known and may be cited as the |
14 | Pharmaceutical Stewardship Act. |
15 | Section 2. Definitions. |
16 | The following words and phrases when used in this act shall |
17 | have the meanings given to them in this section unless the |
18 | context clearly indicates otherwise: |
19 | "Controlled substance." A drug, substance or immediate |
20 | precursor included in Schedules I through V of the act of April |
21 | 14, 1972 (P.L.233, No.64), known as The Controlled Substance, |
22 | Drug, Device and Cosmetic Act. |
23 | "Covered drug." As follows: |
24 | (1) A lawfully obtained prescription drug and |
25 | nonprescription drug. The term includes both brand name and |
26 | generic drugs permitted to be accepted in accordance with |
27 | Federal and State law. |
28 | (2) The term does not include: |
29 | (i) Herbal-based remedies and homeopathic drugs, |
30 | products or remedies. |
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1 | (ii) Cosmetics, shampoos, sunscreens, toothpaste, |
2 | lip balm, antiperspirants or other personal care products |
3 | that are regulated as both cosmetics and proprietary |
4 | drugs under the Federal Food, Drug, and Cosmetic Act (52 |
5 | Stat. 1040, 21 U.S.C. § 301 et seq.). |
6 | (iii) Drugs for which a manufacturer provides a |
7 | take-back program as part of the managed risk evaluation |
8 | and mitigation strategy under 21 U.S.C. § 355-1 (relating |
9 | to risk evaluation and mitigation strategies). |
10 | (iv) Drugs that are biological products as defined |
11 | in 21 CFR 600.3(h) (relating to definitions) as it exists |
12 | on the effective date of this section if the manufacturer |
13 | already provides a take-back program. |
14 | (v) Pet pesticides contained in pet collars, powders |
15 | or shampoos. |
16 | "Department." The Department of Health of the Commonwealth. |
17 | "Drug." Any of the following: |
18 | (1) Substances recognized in the official United States |
19 | Pharmacopeia, or official National Formulary, or any |
20 | supplement to either of them. |
21 | (2) Substances intended for use in the diagnosis, cure, |
22 | mitigation, treatment or prevention of disease in man or |
23 | other animals. |
24 | (3) Substances, other than food, intended to affect the |
25 | structure or any function of the human body or other animal |
26 | body. |
27 | (4) Substances intended for use as a component of any |
28 | article specified under paragraphs (1), (2) and (3). |
29 | "Generic drug." A drug that is chemically identical or |
30 | bioequivalent to a brand name drug in dosage form, safety, |
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1 | strength, route of administration, quality, performance |
2 | characteristics and intended use, though inactive ingredients |
3 | may vary. |
4 | "Mail-back program." A system whereby residential sources of |
5 | unwanted covered drugs obtain prepaid and preaddressed mailing |
6 | envelopes for shipment to an entity that will dispose of them |
7 | safely and legally. |
8 | "Manufacture." As follows: |
9 | (1) Any of the following: |
10 | (i) The production, preparation, propagation, |
11 | compounding, conversion or processing of a drug or |
12 | controlled substance. |
13 | (ii) The packaging or repackaging of a substance |
14 | under subparagraph (i). |
15 | (iii) The labeling or relabeling of the commercial |
16 | container of a substance under subparagraph (i). |
17 | (2) The term does not include the activities of a |
18 | practitioner who, as an incident to his administration or |
19 | dispensing the substance in the course of his professional |
20 | practice, prepares, compounds, packages or labels the |
21 | substance. |
22 | "Manufacturer." A person lawfully authorized to manufacture |
23 | a drug or controlled substance. |
24 | "Nonproprietary drug." A drug or controlled substance |
25 | required by any applicable Federal or State law to be dispensed |
26 | only by prescription. |
27 | "Pharmaceutical stewardship program." A program operated by |
28 | a manufacturer, group of manufacturers or an association for the |
29 | collection, transportation and disposal of unwanted covered |
30 | drugs from residential sources that is financed by the |
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1 | manufacturers of those products. |
2 | "Proprietary drug." Nonprescription, nonnarcotic medicines |
3 | or drugs which may be sold without a prescription and which are |
4 | prepackaged for use by the consumer and labeled in accordance |
5 | with Federal and State requirements. |
6 | "Residential sources." As follows: |
7 | (1) Single and multiple-family residences and locations |
8 | where household drugs are unused, unwanted, disposed or |
9 | abandoned. |
10 | (2) The term does not include drugs from hospitals, |
11 | clinics, pharmacies, airport security, drug seizures by law |
12 | enforcement, businesses or other nonresidential or business |
13 | sources. |
14 | "Ultimate user." A person who lawfully possesses a drug or |
15 | controlled substance for his own use or for the use of a member |
16 | of his household or for administering to an animal in his care. |
17 | "Unwanted covered drug." Any covered drug no longer wanted |
18 | by its ultimate user or that has been abandoned, discarded or is |
19 | intended to be discarded by its ultimate user. |
20 | Section 3. Pharmaceutical stewardship program. |
21 | (a) Participation required.--Beginning January 1, 2014, any |
22 | manufacturer offering a covered drug for sale in this |
23 | Commonwealth must operate or participate in an approved |
24 | pharmaceutical stewardship program prior to offering covered |
25 | drugs for sale in Pennsylvania. |
26 | (b) Submittal.--After January 1, 2014, any manufacturer who |
27 | intends to offer covered drugs for sale in this Commonwealth |
28 | must have received an approval to operate a pharmaceutical |
29 | stewardship program plan from the department or provide evidence |
30 | of having joined an existing pharmaceutical stewardship program |
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1 | to the department at least 45 days prior to the manufacturer's |
2 | initial offer of sale of covered drugs. |
3 | (c) Program requirements.--A pharmaceutical stewardship |
4 | program plan must meet or include all of the following: |
5 | (1) Implementation of the pharmaceutical stewardship |
6 | program without charging a line item fee for the cost of the |
7 | program visible to the consumer at the time of sale of the |
8 | covered drugs or at the time the unwanted covered drugs are |
9 | delivered or collected for disposal from residential sources. |
10 | (2) A description of a proposed collection system which |
11 | shall include all of the following: |
12 | (i) (A) Except as provided under clause (B), at |
13 | least one collection site in each county. At least |
14 | one of the collection sites in each county shall have |
15 | Federal authorization to collect lawfully obtained |
16 | controlled substances. |
17 | (B) Counties with the following populations |
18 | based on the most recent Federal decennial census |
19 | shall have collection sites as follows: |
20 | (I) A county with a population of 100,001 to |
21 | 300,000 shall have at least two collection sites. |
22 | (II) A county with a population of 300,001 |
23 | to 1,000,000 shall have at least three collection |
24 | sites. |
25 | (III) A county with a population in excess |
26 | of 1,000,000 shall have at least four collection |
27 | sites. |
28 | (C) Except for a county of the first class, a |
29 | collection site under this subparagraph may not be |
30 | established in the same municipality as a collection |
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1 | site under subparagraph (ii). |
2 | (ii) At least one collection site in every |
3 | municipality with a population over 50,000 in the most |
4 | recent Federal decennial census. Collection sites |
5 | established under subparagraph (i) may not be used to |
6 | meet the requirements under this subparagraph. |
7 | (iii) A mail-back program for unwanted covered |
8 | drugs. Envelopes for the program must be made available |
9 | at each collection site and to any pharmacy in the county |
10 | interested in providing envelopes to their customers. |
11 | (3) A handling and disposal system, including: |
12 | (i) Identification of and contact information for |
13 | disposal facilities and other entities to be used by the |
14 | program to collect and destroy the unwanted covered |
15 | drugs. |
16 | (ii) The policies and procedures to be followed by |
17 | persons handling and transporting unwanted covered drugs |
18 | collected under the pharmaceutical stewardship program. |
19 | (iii) A description of how the collected unwanted |
20 | covered drugs are tracked through to final disposal and |
21 | how safety and security is maintained. |
22 | (iv) Final disposal or reuse technologies that |
23 | provide superior environmental and human health |
24 | protection compared with current disposal technologies |
25 | for unwanted covered drugs, if approved by the department |
26 | upon petition. The department may not approve the use of |
27 | an alternative proposed technology unless the petitioners |
28 | have presented clear and convincing evidence that the |
29 | technology's performance under field conditions provides |
30 | equivalent protection in each and superior protection in |
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1 | one or more of the following areas: |
2 | (A) Monitoring emissions or waste. |
3 | (B) Worker health and safety. |
4 | (C) Air, water or land emissions contributing to |
5 | persistent, bioaccumulative and toxic pollution. |
6 | (D) Overall impact to the environment and human |
7 | health. |
8 | (v) Separation of unwanted covered drugs from their |
9 | original containers, if appropriate, prior to disposal. |
10 | (4) A list of all entities participating in the |
11 | collection, handling and disposal proposed in the |
12 | pharmaceutical stewardship program and the entities' contact |
13 | information. |
14 | (5) Certification that the pharmaceutical stewardship |
15 | program will accept all unwanted covered drugs, including |
16 | unwanted covered drugs from other manufacturers. |
17 | (6) An education and outreach program that shall |
18 | include: |
19 | (i) A toll-free phone number and a website which |
20 | shall provide information on the pharmaceutical |
21 | stewardship program and a list of all collections sites |
22 | and allow a person to request that a mail-back program |
23 | envelope be mailed to them. |
24 | (ii) Printed brochures and posters describing where |
25 | and how to return unwanted covered drugs provided at no |
26 | cost to pharmacies, health care facilities and other |
27 | interested parties. |
28 | (7) Performance goals, including recovery goals |
29 | expressed as pounds of unwanted covered drugs disposed of per |
30 | capita and an explanation of how the recovery goals have been |
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1 | set to recover a significant percentage of unwanted covered |
2 | drugs relative to the quantity of unwanted covered drugs that |
3 | may be available for disposal. |
4 | (8) Operation of the pharmaceutical stewardship program |
5 | in accordance with this act and other applicable Federal and |
6 | State laws. |
7 | (9) A specific date for implementation. |
8 | (d) Secure and Responsible Drug Disposal Act of 2010.-- |
9 | Within 180 days after promulgation of Federal regulations |
10 | authorized under the Secure and Responsible Drug Disposal Act of |
11 | 2010 (P.L. 111-273), each pharmaceutical stewardship program |
12 | shall submit an updated plan reflecting any necessary changes |
13 | required by the Federal regulations. |
14 | Section 4. Department review and approval. |
15 | (a) Approval required.--No manufacturer or other entity may |
16 | collect unwanted covered drugs until it has received written |
17 | approval or renewal of its pharmaceutical stewardship program |
18 | plan from the department. |
19 | (b) Compliance.--Within 90 days after receipt of a |
20 | pharmaceutical stewardship program plan, the department shall |
21 | determine whether it complies with this act. If it is deemed in |
22 | compliance with this act, the department shall notify the |
23 | applicant of its approval in writing. If the pharmaceutical |
24 | stewardship program plan is rejected, the department shall |
25 | notify the applicant in writing of its reasons for rejection. |
26 | (c) Review.-- |
27 | (1) A manufacturer or other entity operating a |
28 | pharmaceutical stewardship program shall conduct an internal |
29 | evaluation of its program which shall be submitted to the |
30 | department as follows: |
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1 | (i) Two years after implementation of the plan. |
2 | (ii) Five years after implementation of the plan, |
3 | and every five years thereafter. |
4 | (2) The department shall review the internal evaluations |
5 | submitted under this subsection and shall grant or deny |
6 | approval for the continued operation of the program in |
7 | accordance with the procedures under subsection (b). |
8 | (d) Substantive changes.--Any substantive changes to a |
9 | pharmaceutical stewardship program plan must be approved by the |
10 | department in writing. |
11 | Section 5. Report. |
12 | On or before April 1, 2015, and each April thereafter, a |
13 | pharmaceutical stewardship program under section 3(b) must |
14 | prepare and submit an annual report describing the program's |
15 | activities during the previous calendar year to the department. |
16 | The report must include all of the following: |
17 | (1) A list of manufacturers participating in the |
18 | pharmaceutical stewardship program. |
19 | (2) The amount, by weight, of unwanted covered drugs |
20 | collected at each site and the total amount by weight |
21 | collected by a mail-back program. |
22 | (3) A list of the collection sites provided in each |
23 | county, including the location of each collection site and |
24 | locations where envelopes for a mail-back program are |
25 | provided. |
26 | (4) The name and location of disposal facilities at |
27 | which unwanted covered drugs were disposed of and the weight |
28 | of unwanted covered drugs disposed of at each facility. |
29 | (5) If packaging was separated from the unwanted covered |
30 | drugs prior to disposal, the amount and percentage of |
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1 | packaging recycled and the name and location of the material |
2 | recovery facility to which it was delivered. |
3 | (6) Whether policies and procedures for collecting, |
4 | transporting and disposing of unwanted covered drugs, as |
5 | established in the pharmaceutical stewardship program plan, |
6 | were followed during the reporting period and a description |
7 | of any noncompliance. |
8 | (7) Whether any safety or security problems occurred |
9 | during collection, transportation or disposal of unwanted |
10 | covered drugs during the reporting period and, if so, what |
11 | changes have or will be made to policies, procedures or |
12 | tracking mechanisms to alleviate the problem and to improve |
13 | safety and security. |
14 | (8) A description of public education and outreach |
15 | activities implemented during the reporting period, including |
16 | the methodology used to evaluate the outreach and program |
17 | activities. |
18 | (9) Any other information that the agency may reasonably |
19 | require. |
20 | Section 6. Enforcement. |
21 | (a) Penalty for nonimplementation.--If an approved |
22 | pharmaceutical stewardship program plan is not fully implemented |
23 | as follows, the department shall assess the following penalties |
24 | for each calendar day along with written notification to each |
25 | manufacturer associated with the pharmaceutical stewardship |
26 | program plan: |
27 | (1) If full implementation has not occurred within 30 |
28 | days of the start date contained in the pharmaceutical |
29 | stewardship program plan, the department shall assess a |
30 | penalty of $5,000 against the manufacturer or entity that |
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1 | developed the pharmaceutical stewardship program under |
2 | section 3(b). |
3 | (2) If full implementation has not occurred within 60 |
4 | days of the start date contained in the pharmaceutical |
5 | stewardship program plan, the department shall assess a |
6 | penalty of $10,000 against the manufacturer or entity that |
7 | developed the pharmaceutical stewardship program under |
8 | section 3(b). |
9 | (b) Penalty for noncompliance.--If the department finds that |
10 | a pharmaceutical stewardship program is not in compliance with |
11 | its approved plan, the department must notify in writing each |
12 | manufacturer in the pharmaceutical stewardship program of the |
13 | violation and allow the manufacturer or entity operating the |
14 | pharmaceutical stewardship program 30 days to correct the |
15 | noncompliance. After 30 days, the manufacturer or entity |
16 | operating the pharmaceutical stewardship program under section |
17 | 3(b) shall be assessed a penalty of $5,000 for the first |
18 | violation and $10,000 for each subsequent violation. Subsequent |
19 | violations shall occur after each ten days of noncompliance |
20 | under this subsection. |
21 | (c) Penalty for nonparticipation.-- |
22 | (1) Upon first determining that a manufacturer is |
23 | offering a covered drug for sale in this Commonwealth but is |
24 | not participating in a pharmaceutical stewardship program |
25 | approved by the agency, the department shall send the |
26 | manufacturer a written warning that the manufacturer is in |
27 | violation of this act. |
28 | (2) A manufacturer not participating in a pharmaceutical |
29 | stewardship program approved by the department whose covered |
30 | drug continues to be sold in this Commonwealth 60 days after |
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1 | receiving a written warning from the department shall be |
2 | assessed a penalty of $10,000 for each calendar day that the |
3 | violation continues. |
4 | Section 20. Effective date. |
5 | This act shall take effect in 90 days. |
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