Revision: Dec. 6, 2019, 12:20 p.m.
HB 1610-FN - AS INTRODUCED
2020 SESSION
20-2712
01/04
HOUSE BILL 1610-FN
AN ACT establishing the manufacturer pharmaceutical drug take-back program.
SPONSORS: Rep. Loughman, Rock. 21; Rep. Merchant, Sull. 4; Rep. McBeath, Rock. 26; Rep. Muscatel, Graf. 12; Rep. Costable, Rock. 3; Rep. Fowler, Rock. 20; Sen. Fuller Clark, Dist 21; Sen. Sherman, Dist 24; Sen. Chandley, Dist 11; Sen. Bradley, Dist 3
COMMITTEE: Health, Human Services and Elderly Affairs
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ANALYSIS
This bill establishes the manufacturer pharmaceutical drug take-back program. The department of health and human services shall operate the program and adopt rules for its administration.
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Explanation: Matter added to current law appears in bold italics.
Matter removed from current law appears [in brackets and struckthrough.]
Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
20-2712
01/04
STATE OF NEW HAMPSHIRE
In the Year of Our Lord Two Thousand Twenty
AN ACT establishing the manufacturer pharmaceutical drug take-back program.
Be it Enacted by the Senate and House of Representatives in General Court convened:
1 Statement of Intent. The general court finds:
I. Abuse, fatal overdoses, and poisonings from prescription and over-the-counter medicines used in the home have emerged as an epidemic in recent years. Poisoning is the leading cause of unintentional injury-related death in New Hampshire, and more than 90 percent of poisoning deaths are due to drug overdoses. Poisoning by prescription and over-the-counter medicines is also one of the most common means of suicide and suicide attempts, with poisonings involved in more than 28,000 suicide attempts between 2004 and 2013.
II. Home medicine cabinets are the most common source of prescription drugs that are diverted and misused. Studies find about 70 percent of those who abuse prescription medicines obtain the drugs from family members or friends, usually for free. People who are addicted to heroin often first abused prescription opiate medicines. Unused, unwanted, and expired medicines that accumulate in homes increase risks of drug abuse, overdoses, and preventable poisonings.
III. A safe system for the collection and disposal of unused, unwanted, and expired medicines is a key element of a comprehensive strategy to prevent prescription drug abuse, but disposing of medicines by flushing them down the toilet or placing them in the garbage can contaminate groundwater and other bodies of water, contributing to long-term harm to the environment and animal life.
IV. Therefore, the general court hereby establishes a uniform drug "take-back" program operated and funded by drug manufacturers.
2 New Chapter; Manufacturer Pharmaceutical Drug Take-Back Program. Amend RSA by inserting after chapter 318-E the following new chapter:
CHAPTER 318-F
MANUFACTURER PHARMACEUTICAL DRUG TAKE-BACK PROGRAM
318-F:1 Definitions. In this chapter:
I. "Administer" means the direct application of a legend drug whether by injection, inhalation, ingestion, or any other means, to the body of the patient or research subject by:
(a) A practitioner; or
(b) The patient or research subject at the direction of the practitioner.
II. "Authorized collector" means any of the following persons or entities that have entered into an agreement with a program operator to collect covered drugs:
(a) A person or entity that is registered with the United States Drug Enforcement Administration (DEA) and that qualifies under federal law to modify its registration to collect controlled substances for the purpose of destruction;
(b) A law enforcement agency; or
(c) An entity authorized by the department to provide an alternative collection mechanism for certain covered drugs that are not controlled substances.
III. "Collection site" means the location where an authorized collector operates a secure collection receptacle for collecting covered drugs.
IV. "Covered drug" means a drug from a covered entity that the covered entity no longer wants and that the covered entity has abandoned or discarded or intends to abandon or discard. "Covered drug" includes legend drugs and nonlegend drugs, brand name and generic drugs, drugs for veterinary use for household pets, and drugs in medical devices and combination products.
V. "Covered drug" shall not include:
(a) Vitamins, minerals, or supplements.
(b) Herbal-based remedies and homeopathic drugs, products, or remedies.
(c) Controlled substances contained in schedule I under RSA 318-B.
(d) Cosmetics, shampoos, sunscreens, lip balm, toothpaste, antiperspirants, or other personal care products that are regulated as both cosmetics and nonprescription drugs under the United States Food and Drug Administration (FDA).
(e) Drugs for which manufacturers provide a pharmaceutical product stewardship or drug take-back program as part of a FDA managed risk evaluation and mitigation strategy.
(f) Biological drug products, as defined by 21 C.F.R. section 600.3(h), for which manufacturers provide a pharmaceutical product stewardship or drug take-back program and who provide the department with a report describing the program, including how the drug product is collected and safely disposed and how patients are made aware of the drug take-back program, and who updates the department on changes that substantially alter their drug take-back program.
(g) Drugs that are administered in a clinical setting.
(h) Emptied injector products or emptied medical devices and their component parts or accessories.
(i) Exposed needles or sharps, or used drug products that are medical wastes.
(j) Pet pesticide products contained in pet collars, powders, shampoos, topical applications, or other forms.
VI. "Covered entity" means a state resident or other nonbusiness entity and includes an ultimate user, as defined by regulations adopted by the DEA. "Covered entity" shall not include a business generator of pharmaceutical waste, such as a hospital, clinic, health care provider's office, veterinary clinic, pharmacy, or law enforcement agency.
VII. "Covered manufacturer" means a person, corporation, or other entity engaged in the manufacture of covered drugs sold in or into New Hampshire. "Covered manufacturer" shall not include:
(a) A private label distributor or retail pharmacy that sells a drug under the retail pharmacy's store label if the manufacturer of the drug is identified under RSA 318-F:3;
(b) A repackager if the manufacturer of the drug is identified under RSA 318-F:3; or
(c) A nonprofit, 501(c)(3) health care corporation that repackages drugs solely for the purpose of supplying a drug to facilities or retail pharmacies operated by the corporation or an affiliate of the corporation if the manufacturer of the drug is identified under RSA 318-F:3.
VIII. "Department" means the department of health and human services.
IX. "Drug" means:
(a) Substances recognized as drugs in the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, or official national formulary, or any supplement to any of them.
(b) Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or animals.
(c) Substances other than food, minerals, or vitamins that are intended to affect the structure or any function of the body of human beings or animals.
(d) Substances intended for use as a component of any article specified in this paragraph.
X. "Drug take-back organization" means an organization designated by a manufacturer or group of manufacturers to act as an agent on behalf of each manufacturer to develop and implement a drug take-back program.
XI. "Drug take-back program" or "program" means a program implemented by a program operator for the collection, transportation, and disposal of covered drugs.
XII. "Drug wholesaler" means an entity licensed as a wholesaler.
XIII. "Generic drug" means 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. The inactive ingredients in a generic drug need not be identical to the inactive ingredients in the chemically identical or bioequivalent brand name drug.
XIV. "Legend drug" means a drug, including a controlled substance under RSA 318-B, that is required by any applicable federal or state law or regulation to be dispensed by prescription only or that is restricted to use by practitioners only.
XV. "Mail-back distribution location" means a facility, such as a town hall or library, that offers prepaid, preaddressed mailing envelopes to covered entities.
XVI. "Mail-back program" means a method of collecting covered drugs from covered entities by using prepaid, preaddressed mailing envelopes.
XVII. Manufacture" means the production, preparation, propagation, compounding, or processing of a drug or other substance or device or the packaging or repackaging of such substance or device, or the labeling or relabeling of the commercial container of such substance or device, but does not include the activities of a practitioner who, as an incident to his or her administration or dispensing such substance or device in the course of his or her professional practice, personally prepares, compounds, packages, or labels such substance or device. "Manufacture" includes the distribution of a licensed pharmacy compounded drug product to other state licensed persons or commercial entities for subsequent resale or distribution, unless a specific product item has approval of the commission. "Manufacture shall not include:
(a) The activities of a licensed pharmacy that compounds a product on or in anticipation of an order of a licensed practitioner for use in the course of their professional practice to administer to patients, either personally or under their direct supervision;
(b) The practice of a licensed pharmacy when repackaging commercially available medication in small, reasonable quantities for a practitioner legally authorized to prescribe the medication for office use only;
(c) The distribution of a drug product that has been compounded by a licensed pharmacy to other appropriately licensed entities under common ownership or control of the facility in which the compounding takes place; or
(d) The delivery of finished and appropriately labeled compounded products dispensed pursuant to a valid prescription to alternate delivery locations, other than the patient's residence, when requested by the patient, or the prescriber to administer to the patient, or to another licensed pharmacy to dispense to the patient.
XVIII. "Nonlegend drug" means a drug that may be lawfully sold without a prescription.
XIX. "Pharmacy" means a pharmacy licensed under RSA 318.
XX. "Private label distributor" means a company that has a valid labeler code under 21 C.F.R. section 207.17 and markets a drug product under its own name, but does not perform any manufacturing.
XXI. "Program operator" means a drug take-back organization, covered manufacturer, or group of covered manufacturers that implements or intends to implement a drug take-back program approved by the department.
XXII. "Repackager" means a person who owns or operates an establishment that repacks and relabels a product or package containing a covered drug for further sale, or for distribution without further transaction.
XXIII. "Retail pharmacy" means a place licensed as a pharmacy under RSA 318.
318-F:2 Requirement to Participate in a Drug Take-Back Program. A covered manufacturer shall establish and implement a drug take-back program that complies with the requirements of this chapter. A manufacturer that becomes a covered manufacturer after the effective date of this chapter shall, no later than 6 months after the date on which the manufacturer became a covered manufacturer, participate in an approved drug take-back program or establish and implement a drug take-back program that complies with the requirements of this chapter. A covered manufacturer may establish and implement a drug take-back program independently, as part of a group of covered manufacturers, or through membership in a drug take-back organization.
318-F:3 Identification of Covered Manufacturers.
I. No later than 90 days after the effective date of this chapter, a drug wholesaler that sells a drug in or into New Hampshire shall provide a list of drug manufacturers to the department in a form agreed upon with the department. A drug wholesaler shall provide an updated list to the department on January 15 of each year.
II. No later than 90 days after the effective date of this chapter, a retail pharmacy, private label distributor, or repackager shall provide written notification to the department identifying the drug manufacturer from which the retail pharmacy, private label distributor, or repackager obtains a drug that it sells under its own label.
III. A person or entity that receives a letter of inquiry from the department regarding whether or not it is a covered manufacturer under this chapter shall respond in writing no later than 60 days after receipt of the letter. If the person or entity does not believe it is a covered manufacturer for purposes of this chapter, it shall:
(a) State the basis for the belief;
(b) Provide a list of any drugs it sells, distributes, repackages, or otherwise offers for sale within the state; and
(c) Identify the name and contact information of the manufacturer of the drugs identified under subparagraph (b).
318-F:4 Drug Take-Back Program Approval.
I. By July 1, 2021, a program operator shall submit a proposal for the establishment and implementation of a drug take-back program to the department for approval. The department shall approve a proposed program if the applicant submits a completed application, the proposed program meets the requirements of paragraph II, and the applicant pays the appropriate fee established by the department under RSA 318-F:11.
II. To be approved by the department, a proposed drug take-back program shall:
(a) Identify and provide contact information for the program operator and each participating covered manufacturer.
(b) Identify and provide contact information for the authorized collectors for the proposed program, as well as the reasons for excluding any potential authorized collectors from participation in the program.
(c) Provide for a collection system that complies with this chapter.
(d) Provide for a handling and disposal system that complies with RSA 318-F:7.
(e) Identify any transporters and waste disposal facilities that the program will use.
(f) Adopt policies and procedures to be followed by persons handling covered drugs collected under the program to ensure safety, security, and compliance with regulations adopted by the DEA, and any applicable laws.
(g) Ensure the security of patient information on drug packaging during collection, transportation, recycling, and disposal.
(h) Promote the program by providing consumers, pharmacies, and other entities with educational and informational materials as required by RSA 318-F:6.
(i) Demonstrate adequate funding for all administrative and operational costs of the drug take-back program, with costs apportioned among participating covered manufacturers.
(j) Set long-term and short-term goals with respect to collection amounts and public awareness.
(k) Consider:
(1) The use of existing providers of pharmaceutical waste transportation and disposal services.
(2) Separation of covered drugs from packaging to reduce transportation and disposal costs.
(3) Recycling of drug packaging.
III.(a) No later than 120 days after receipt of a drug take-back program proposal, the department shall either approve or reject the proposal in writing to the applicant. The department may extend the deadline for approval or rejection of a proposal for good cause. If the department rejects the proposal, it shall provide the reason for rejection.
(b) No later than 90 days after receipt of a notice of rejection under subparagraph (a), the applicant shall submit a revised proposal to the department. The department shall either approve or reject the revised proposal in writing to the applicant within 90 days after receipt of the revised proposal, including the reason for rejection, if applicable.
(c) If the department rejects a revised proposal, the department may:
(1) Require the program operator to submit a further revised proposal;
(2) Develop and impose changes to some or all of the revised proposal to address deficiencies;
(3) Require the covered manufacturer or covered manufacturers that proposed the rejected revised proposal to participate in a previously approved drug take-back program; or
(4) Find the covered manufacturer out of compliance with the requirements of this chapter and take enforcement action as provided in RSA 318-F:10.
IV. The program operator shall initiate operation of an approved drug take-back program no later than one 180 days after approval of the proposal by the department.
V.(a) Proposed changes to an approved drug take-back program that substantially alter program operations shall have prior written approval of the department. A program operator shall submit to the department such a proposed change in writing at least 15 days before the change is scheduled to occur. Changes requiring prior approval of the department include changes to participating covered manufacturers, collection methods, achievement of the service convenience goal described in RSA 318-F:5, policies and procedures for handling covered drugs, education and promotion methods, and selection of disposal facilities.
(b) For changes to a drug take-back program that do not substantially alter program operations, a program operator shall notify the department at least 7 days before implementing the change. Changes that do not substantially alter program operations include changes to collection site locations, methods for scheduling and locating periodic collection events, and methods for distributing prepaid, preaddressed mailers.
(c) A program operator shall notify the department of any changes to the official point of contact for the program no later than 15 days after the change. A program operator shall notify the department of any changes in ownership or contact information for participating covered manufacturers no later than ninety days after such change.
VI. No later than 4 years after a drug take-back program initiates operations, and every 4 years thereafter, the program operator shall submit an updated proposal to the department describing any substantive changes to program. The department shall approve or reject the updated proposal under the process outlined in paragraph III.
VII. The department shall make all proposals submitted under this section available to the public and shall provide an opportunity for written public comment on each proposal.
318-F:5 Collection System.
I.(a) At least 120 days prior to submitting a proposal under RSA 318-F:4, a program operator shall notify potential authorized collectors of the opportunity to serve as an authorized collector for the proposed drug take-back program. A program operator shall commence good faith negotiations with a potential authorized collector no later than 30 days after the potential authorized collector expresses interest in participating in a proposed program.
(b) A person or entity may serve as an authorized collector for a drug take-back program voluntarily or in exchange for compensation, but nothing in this chapter requires a person or entity to serve as an authorized collector.
(c) A drug take-back program shall include as an authorized collector any retail pharmacy, hospital or clinic with an on-site pharmacy, or law enforcement agency that offers to participate in the program without compensation and meets the requirements of this section. Such a pharmacy, hospital, clinic, or law enforcement agency shall be included as an authorized collector in the program no later than 90 days after receiving the offer to participate.
(d) A drug take-back program may also locate collection sites at:
(1) A long-term care facility where a pharmacy, or a hospital or clinic with an on-site pharmacy, operates a secure collection receptacle.
(2) A substance use disorder treatment program.
(3) Any other authorized collector willing to participate as a collection site and able to meet the requirements of paragraph I.
II.(a) A collection site shall accept all covered drugs from covered entities during the hours that the authorized collector is normally open for business with the public.
(b) A collection site located at a long-term care facility may only accept covered drugs that are in the possession of individuals who reside or have resided at the facility.
(c) A collection site shall use secure collection receptacles in compliance with state and federal law, including any applicable on-site storage and hazardous waste collection standards and DEA regulations. The program operator shall provide a service schedule that meets the needs of each collection site to ensure that each secure collection receptacle is serviced as often as necessary to avoid reaching capacity and that collected covered drugs are transported to final disposal in a timely manner, including a process for additional prompt collection service upon notification from the collection site. Secure collection receptacle signage shall prominently display a toll-free telephone number and Internet website for the program so that members of the public may provide feedback on collection activities.
(d) An authorized collector shall comply with applicable state and federal laws that establish collection and transportation standards, and federal laws and regulations governing the handling of covered drugs, including DEA regulations.
III.(a) A drug take-back program's collection system shall be safe, secure, and convenient on an ongoing, year-round basis and shall provide equitable and reasonably convenient access for residents across the state.
(b) In establishing and operating a collection system, a program operator shall give preference to locating collection sites at retail on-site pharmacies, hospitals or clinics with on-site pharmacies, and law enforcement agencies.
(c)(1) Each population center shall have a minimum of one collection site, plus one additional collection site for every 50,000 residents of the city or town located within the population center. Collection sites shall be geographically distributed to provide reasonably convenient and equitable access to all residents of the population center.
(2) On islands and in areas outside of population centers, a collection site shall be located at the site of each potential authorized collector that is regularly open to the public, unless the program operator demonstrates to the satisfaction of the department that a potential authorized collector is unqualified or unwilling to participate in the drug take-back program, in accordance with the requirements of paragraph I.
(3) For purposes of this section, "population center" means a city or town and the unincorporated area within a 10-mile radius from the center of the city or town.
(d) A program operator shall establish mail-back distribution locations or hold periodic collection events to supplement service to any area of the state that is underserved by collection sites, as determined by the department, in consultation with the local health jurisdiction. The program operator, in consultation with the department, local law enforcement, the local health jurisdiction, and the local community, shall determine the number and locations of mail-back distribution locations or the frequency and location of these collections events, to be held at least twice a year, unless otherwise determined through consultation with the local community. The program shall arrange any periodic collection events in advance with local law enforcement agencies and conduct periodic collection events in compliance with DEA regulations and protocols and applicable state laws.
(e) Upon request, a drug take-back program shall provide a mail-back program free of charge to covered entities and to retail pharmacies that offer to distribute prepaid, preaddressed mailing envelopes for the drug take-back program. A drug take-back program shall permit covered entities to request prepaid, preaddressed mailing envelopes through the program's website, the program's toll-free telephone number, and a request to a pharmacist at a retail pharmacy distributing the program's mailing envelopes.
(f) The program operator shall provide alternative collection methods for any covered drugs, other than controlled substances, that cannot be accepted or commingled with other covered drugs in secure collection receptacles, through a mail-back program, or at periodic collection events, to the extent permissible under applicable state and federal laws. The department shall review and approve of any alternative collection methods prior to their implementation.
318-F:6 Drug Take-Back Program Promotion.
I. A drug take-back program shall develop and provide a system of promotion, education, and public outreach about the safe storage and secure collection of covered drugs. This system may include signage, written materials to be provided at the time of purchase or delivery of covered drugs, and advertising or other promotional materials. At a minimum, each program shall:
(a) Promote the safe storage of legend drugs and nonlegend drugs by residents before secure disposal through a drug take-back program.
(b) Discourage residents from disposing of covered drugs in solid waste collection, sewer, or septic systems.
(c) Promote the use of the drug take-back program so that where and how to return covered drugs is widely understood by residents, pharmacists, retail pharmacies, health care facilities and providers, veterinarians, and veterinary hospitals.
(d) Establish a toll-free telephone number and website publicizing collection options and collection sites and discouraging improper disposal practices for covered drugs, such as flushing them or placing them in the garbage.
(e) Prepare educational and outreach materials that: Promote safe storage of covered drugs; discourage the disposal of covered drugs in solid waste collection, sewer, or septic systems; and describe how to return covered drugs to the drug take-back program. The materials shall use plain language and explanatory images to make collection services and discouraged disposal practices readily understandable to all residents, including residents with limited English proficiency.
(f) Disseminate the educational and outreach materials described in subparagraph (e) to pharmacies, health care facilities, and other interested parties for dissemination to covered entities.
(g) Work with authorized collectors to develop a readily recognizable, consistent design of collection receptacles, as well as clear, standardized instructions for covered entities on the use of collection receptacles. The department may provide guidance to program operators on the development of the instructions and design.
(h) Annually report on its promotion, outreach, and public education activities in its annual report required by RSA 318-F:9.
II. If more than one drug take-back program is approved by the department, the programs shall coordinate their promotional activities to ensure that all state residents can easily identify, understand, and access the collection services provided by any drug take-back program. Coordination efforts shall include providing residents with a single toll-free telephone number and single website to access information about collection services for every approved program.
III. Pharmacies and other entities that sell medication in New Hampshire are encouraged to promote secure disposal of covered drugs through the use of one or more approved drug take-back programs. Upon request, a pharmacy shall provide materials explaining the use of approved drug take-back programs to its customers. The program operator shall provide pharmacies with these materials upon request and at no cost to the pharmacy.
IV. The department shall, through its standard educational methods, promote safe storage of prescription and nonprescription drugs by covered entities, secure disposal of covered drugs through a drug take-back program, and the toll-free telephone number and website for approved drug take-back programs. Local health jurisdictions and local government agencies are encouraged to promote approved drug take-back programs.
V. The department:
(a) Shall conduct a survey of covered entities and a survey of pharmacists, health care providers, and veterinarians who interact with covered entities on the use of medicines after the first full year of operation of the drug take-back program, and again every 2 years thereafter. Survey questions shall: measure consumer awareness of the drug take-back program; assess the extent to which collection sites and other collection methods are convenient and easy to use; assess knowledge and attitudes about risks of abuse, poisonings, and overdoses from drugs used in the home; and assess covered entities' practices with respect to unused, unwanted, or expired drugs, both currently and prior to implementation of the drug take-back program; and
(b) May, upon review of results of public awareness surveys, direct a program operator for an approved drug take-back program to modify the program's promotion and outreach activities to better achieve widespread awareness among New Hampshire residents and health care professionals about where and how to return covered drugs to the drug take-back program.
318-F:7 Disposal and Handling of Covered Drugs.
I. Covered drugs collected under a drug take-back program shall be disposed of at a permitted hazardous waste disposal facility that meets the requirements of 40 C.F.R. parts 264 and 265.
II. If use of a hazardous waste disposal facility described in paragraph I is unfeasible based on cost, logistics, or other considerations, the department, in consultation with the department of environmental services, may grant approval for a program operator to dispose of some or all collected covered drugs at a permitted large municipal waste combustor facility that meets the requirements of 40 C.F.R. parts 60 and 62.
III. A program operator may petition the department for approval to use final disposal technologies or processes that provide superior environmental and human health protection than that provided by the technologies described in paragraphs I and II, or equivalent protection at less cost. In reviewing a petition under this section, the department shall take into consideration regulations or guidance issued by the United States Environmental Protection Agency on the disposal of pharmaceutical waste. The department, in consultation with the department of environmental services, shall approve a disposal petition under this section if the disposal technology or processes described in the petition provides equivalent or superior protection in each of the following areas:
(a) Monitoring of any 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.
IV. If a drug take-back program encounters a safety or security problem during collection, transportation, or disposal of covered drugs, the program operator shall notify the department as soon as practicable after encountering the problem.
318-F:8 Program Funding.
I. A covered manufacturer or group of covered manufacturers shall pay all administrative and operational costs associated with establishing and implementing the drug take-back program in which they participate. Such administrative and operational costs include, but are not limited to: collection and transportation supplies for each collection site; purchase of secure collection receptacles for each collection site; ongoing maintenance or replacement of secure collection receptacles when requested by authorized collectors; prepaid, preaddressed mailers; compensation of authorized collectors, if applicable; operation of periodic collection events, including the cost of law enforcement staff time; transportation of all collected covered drugs to final disposal; environmentally sound disposal of all collected covered drugs in compliance with RSA 318-F:7; and program promotion and outreach.
II. A program operator, covered manufacturer, authorized collector, or other person shall not charge:
(a) A specific point-of-sale fee to consumers to recoup the costs of a drug take-back program; or
(b) A specific point-of-collection fee at the time covered drugs are collected from covered entities.
318-F:9 Annual Program Report.
I. By July 1 after the first full year of implementation, and each July 1 thereafter, a program operator shall submit to the department a report describing implementation of the drug take-back program during the previous calendar year. The report shall include:
(a) A list of covered manufacturers participating in the drug take-back program.
(b) The amount, by weight, of covered drugs collected, including the amount by weight from each collection method used.
(c) The following details regarding the program's collection system: A list of collection sites with addresses; the number of mailers provided; locations where mailers were provided, if applicable; dates and locations of collection events held, if applicable; and the transporters and disposal facility or facilities used.
(d) Whether any safety or security problems occurred during collection, transportation, or disposal of covered drugs, and if so, completed and anticipated changes to policies, procedures, or tracking mechanisms to address the problem and improve safety and security.
(e) A description of the public education, outreach, and evaluation activities implemented.
(f) A description of how collected packaging was recycled to the extent feasible.
(g) A summary of the program's goals for collection amounts and public awareness, the degree of success in meeting those goals, and if any goals have not been met, what effort will be made to achieve those goals the following year.
(h) The program's annual expenditures, itemized by program category.
II. Within 30 days after each annual period of operation of an approved drug take-back program, the program operator shall submit an annual collection amount report to the department that provides the total amount, by weight, of covered drugs collected from each collection site during the prior year.
III. The department shall make reports submitted under this section available to the public through its Internet website.
318-F:10 Enforcement and Penalties.
I. The department may audit or inspect the activities and records of a drug take-back program to determine compliance with this chapter or investigate a complaint.
II.(a) The department shall send a written notice to a covered manufacturer that fails to participate in a drug take-back program as required by this chapter. The notice shall provide a warning regarding the penalties for violation of this chapter.
(b) A covered manufacturer that receives a notice under this paragraph may be assessed a penalty if, 60 days after receipt of the notice, the covered manufacturer continues to sell a covered drug in or into the state without participating in a drug take-back program approved under this chapter.
III.(a) The department may send a program operator a written notice warning of the penalties for noncompliance with this chapter if it determines that the program operator's drug take-back program is in violation of this chapter or does not conform to the proposal approved by the department. The department may assess a penalty on the program operator and participating covered manufacturers if the program does not come into compliance by thirty days after receipt of the notice.
(b) The department may immediately suspend operation of a drug take-back program and assess a penalty if it determines that the program is in violation of this chapter and the violation creates a condition that, in the judgment of the department, constitutes an immediate hazard to the public or the environment.
IV.(a) The department shall send a written notice to a drug wholesaler or a retail pharmacy that fails to provide a list of drug manufacturers to the department as required by RSA 318-F:3. The notice shall provide a warning regarding the penalties for violation of this chapter.
(b) A drug wholesaler or retail pharmacy that receives a notice under this paragraph may be assessed a penalty if, 60 days after receipt of the notice, the drug wholesaler or retail pharmacy fails to provide a list of drug manufacturers.
V. In enforcing the requirements of this chapter, the department may:
(a) Require an informal administrative conference.
(b) Require a person or entity to engage in or refrain from engaging in certain activities pertaining to this chapter.
(c) Assess a civil fine of up to $2,000. Each day upon which a violation occurs or is permitted to continue constitutes a separate violation. In determining the appropriate amount of the fine, the department shall consider the extent of harm caused by the violation, the nature and persistence of the violation, the frequency of past violations, any action taken to mitigate the violation, and the financial burden to the entity in violation.
(d) Not prohibit a covered manufacturer from selling a drug in or into the state of New Hampshire.
318-F:11 Fees.
I.(a) The department shall determine its costs for the administration, oversight, and enforcement of this chapter, including the survey required under RSA 318-F:18; set fees at a level sufficient to recover the costs associated with administration, oversight, and enforcement; and adopt rules under RSA 541-A establishing requirements for program operator proposals.
(b) The department shall not impose any fees in excess of its actual administrative, oversight, and enforcement costs. The fees collected from each program operator in calendar year 2021 and any subsequent year shall not exceed 10 percent of the program's annual expenditures as reported to the department in the annual report required by RSA 318-F:9 and determined by the department.
(c) Adjustments to the department's fees may be made annually and shall not exceed actual administration, oversight, and enforcement costs. Adjustments for inflation shall not exceed the percentage change in the consumer price index for all urban consumers in the United States as calculated by the United States department of labor as averaged by city for the 12-month period ending with June of the previous year.
(d) The department shall collect fees from each program operator by October 1, 2021, and annually thereafter.
(2) All fees collected under this section shall be deposited in the secure drug take-back program account established in RSA 318-F:12.
318-F:12 Secure Drug Take-Back Program Account. There is hereby established the secure drug take-back program account. Moneys received by the department under this chapter shall be deposited in the fund. The fund shall be nonlapsing and continually appropriated to the department for the purpose of the administration of this chapter.
318-F:13 Antitrust Immunity. The activities authorized under this chapter require collaboration among covered manufacturers. These activities will enable safe and secure collection and disposal of covered drugs in New Hampshire and are therefore in the best interest of the public. The benefits of collaboration, together with active state supervision, outweigh potential adverse impacts. Therefore, the general court intends to exempt from state antitrust laws, and provide immunity through the state action doctrine from federal antitrust laws, activities that are undertaken, reviewed, and approved by the department pursuant to this chapter that might otherwise be constrained by such laws. The general court does not intend and does not authorize any person or entity to engage in activities not provided for by this chapter, and the general court neither exempts nor provides immunity for such activities.
318-F:14 Federal Law. This chapter is void if a federal law, or a combination of federal laws, takes effect that establishes a national program for the collection of covered drugs that substantially meets the intent of this chapter, including the creation of a funding mechanism for collection, transportation, and proper disposal of all covered drugs in the United States.
318-F:15 Public Disclosure. Proprietary information submitted to the department under this chapter shall be exempt from public disclosure under RSA 91-A. The department may use and disclose such information in summary or aggregated form that does not directly or indirectly identify financial, production, or sales data of an individual covered manufacturer or drug take-back organization.
318-F:16 Rulemaking. The commissioner of the department shall adopt rules, pursuant to RSA 541-A, necessary to implement and enforce this chapter.
318-F:17 Report Required.
I. No later than 30 days after the department first approves a drug take-back program under RSA 318-F:4, the department shall submit a report to the speaker of the house of representatives, president of the senate, and the governor describing rules adopted under this chapter and the approved drug take-back program.
II. By November 15 after the first full year of operation of an approved drug take-back program and biennially thereafter, the department shall submit a report to the speaker of the house of representatives, the president of the senate, and the governor. The report shall:
(a) Describe the status of approved drug take-back programs;
(b) Evaluate the secure medicine collection and disposal system and the program promotion, education, and public outreach requirements established by this chapter;
(c) Evaluate, in conjunction with an academic institution that is not an agency of the state and is qualified to conduct and evaluate research relating to prescription and nonprescription drug use and abuse and environmental impact, to the extent feasible, the impact of approved drug take-back programs on: awareness and compliance of residents with safe storage of medicines in the home and secure disposal of covered drugs; rates of misuse, abuse, overdoses, and poisonings from prescription and nonprescription drugs; and diversions of covered drugs from sewer, solid waste, and septic systems. To conduct this evaluation, the department and the academic institution may rely on available data sources, including the public awareness surveys required under this chapter, and the prescription drug monitoring program and public health surveys such as the New Hampshire healthy youth survey. The department and the academic institution may also consult with other state and local agencies and interested stakeholders; and
(d) Provide any recommendations for legislation.
318-F:18 Contract Required.
I.(a) The department shall contract with an appropriate entity to conduct a survey of residents to measure whether the secure medicine collection and disposal system and the program promotion, education, and public outreach requirements established in this chapter have led to statistically significant changes in resident attitudes and behavior on safe storage and secure disposal of prescription and nonprescription medications used in the home and the rates of abuse or misuse of or accidental exposure to prescription and nonprescription drugs.
(b) The survey of residents shall include telephone follow-up with users of the program's emergency telephone service. The survey shall be conducted before the secure medicine collection and disposal system is implemented and again no earlier than 4 years after the system is implemented.
II. The contracted entity shall report the survey results to the speaker of the house of representatives, the president of the senate, and the governor and the department of health within 6 months of completion of the survey.
3 New Subparagraph; Application of Receipts. Amend RSA 6:12, I(b) by inserting after subparagraph (358) the following new subparagraph:
(359) Moneys deposited in the secure drug take-back program account established in RSA 318-F:12.
4 Effective Date. This act shall take effect January 1, 2021.
20-2712
12/5/19
HB 1610-FN- FISCAL NOTE
AS INTRODUCED
AN ACT creating a system for safe and secure collection and disposal of unwanted medications.
FISCAL IMPACT: [ X ] State [ ] County [ ] Local [ ] None
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| Estimated Increase / (Decrease) | |||
STATE: | FY 2020 | FY 2021 | FY 2022 | FY 2023 |
Appropriation | $0 | $0 | $0 | $0 |
Revenue | $0 | $0 | $0 | $0 |
Expenditures | $0 | $106,700+ | $219,800+ | $230,000+ |
Funding Source: | [ X ] General [ ] Education [ ] Highway [ ] Other | |||
METHODOLOGY:
This bill requires the Department of Health and Human Services to operate a manufacturer pharmaceutical drug take-back program. Among the Department's responsibilities would be: collecting data from wholesalers, retail pharmacies, and private label distributors; evaluating proposals for the establishment of drug take-back programs; providing consultation on the need for additional services to supplement underserved areas of the State; providing guidance on the design and standardized instructions for labeling collection receptacles; and promoting the programs and conducting a survey of health care providers every two years. The bill requires the biennial surveys to: measure consumer awareness of the program; assess ease and convenience; assess perception of harm of potential abuse, poisonings, and overdoses from drugs in the home; and assess covered entities' practices with respect to unused, unwanted, or expired drugs.
The bill has an effective date of January 1, 2021. The Department states that in order to implement the program, it will need the following three full-time staff:
| FY 2021 | FY 2022 | FY 2023 |
Program Specialist IV (LG 26) |
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Salary | $26,600 | $54,400 | $56,800 |
Benefits | $14,800 | $30,900 | $32,500 |
Position Total | $41,400 | $85,300 | $89,300 |
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Program Specialist II (LG 23) |
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Salary | $23,400 | $47,800 | $49,900 |
Benefits | $14,200 | $29,600 | $31,100 |
Position Total | $37,600 | $77,400 | $81,000 |
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Program Specialist I (LG 12) |
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Salary | $15,100 | $30,800 | $32,000 |
Benefits | $12,600 | $26,300 | $27,700 |
Position Total | $27,700 | $57,100 | $59,700 |
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Total Position Costs: | $106,700 | $219,800 | $230,000 |
In addition to the above personnel costs, the Department assumes there will be costs associated with conducting the biennial survey. Assuming a total population of 33,000-34,000 providers (25,000 health providers, 6,000 pharmacists, and 2,000-3,000 veterinarians), the survey would need to be sent to 7,000 in order to receive responses from 1,000 providers, given a typical response rate of 10-15 percent. Related printing and mailing costs would need to be considered, but are not reflected in the cost estimate presented above.
AGENCIES CONTACTED:
Department of Health and Human Services