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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.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.