2020 -- H 7128 | |
======== | |
LC003065 | |
======== | |
STATE OF RHODE ISLAND | |
IN GENERAL ASSEMBLY | |
JANUARY SESSION, A.D. 2020 | |
____________ | |
A N A C T | |
RELATING TO FOOD AND DRUGS | |
| |
Introduced By: Representatives Corvese, Canario, Vella-Wilkinson, Azzinaro, and Ucci | |
Date Introduced: January 16, 2020 | |
Referred To: House Health, Education & Welfare | |
It is enacted by the General Assembly as follows: | |
1 | SECTION 1. Title 21 of the General Laws entitled "FOOD AND DRUGS" is hereby |
2 | amended by adding thereto the following chapter: |
3 | CHAPTER 38 |
4 | DRUG TAKE BACK PROGRAM |
5 | 21-38-1. Definitions. |
6 | As used in this chapter, unless the context clearly requires otherwise: |
7 | (1) "Authorized collector" means: |
8 | (i) A person, company, corporation or other entity that is registered with the United States |
9 | Drug Enforcement Administration to collect controlled substances for the purposes of safe |
10 | disposal and destruction; |
11 | (ii) A law enforcement agency; or |
12 | (iii) A person, company, corporation or other entity authorized by the department to |
13 | provide alternative collection methods for covered drugs that are not controlled substances. |
14 | (2) "Covered drug" means any substance recognized as a drug under 21 USC § 321(g)(1), |
15 | as amended, and any regulations promulgated thereunder that is sold, offered for sale or |
16 | dispensed in the state, whether directly or through a wholesaler, in any form including |
17 | prescription and nonprescription drugs, drugs in medical devices and combination products, |
18 | brand and generic drugs and drugs for veterinary use; provided however, covered drug shall not |
19 | include: |
| |
1 | (i) Vitamins or supplements; |
2 | (ii) Herbal-based remedies and homeopathic drugs, products or remedies; |
3 | (iii) Cosmetics, soap (with or without germicidal agents), laundry detergent, bleach, |
4 | household cleaning products, shampoos, sunscreens, toothpaste, lip balm, antiperspirants or other |
5 | personal care products that are regulated as both cosmetics and nonprescription drugs under the |
6 | Federal Food, Drug, and Cosmetic Act; |
7 | (iv) Pet pesticide products contained in pet collars, powders, shampoos, topical |
8 | applications, or other forms; |
9 | (v) Drugs that are biological products as defined in § 5-19.1-2; |
10 | (vi) Drugs for which a manufacturer provides a take back program as part of a Federal |
11 | Food and Drug Administration managed risk evaluation and mitigation strategy; |
12 | (vii) Emptied injector products or emptied medical devices and their component parts or |
13 | accessories; and |
14 | (viii) Drugs that are used solely in a clinical setting. |
15 | (3) "Department" means the department of health. |
16 | (4) "Drug take back organization" means an organization designated by a manufacturer or |
17 | a group of manufacturers to act as an agent on behalf of the manufacturer or group of |
18 | manufacturers to operate and implement a drug take back program as authorized by this chapter. |
19 | (5) "Manufacturer" means a person, company, corporation or other entity engaged in the |
20 | manufacture of covered drugs sold in the state and governed by chapter 19.1 of title 5. |
21 | Manufacturer does not include a repackager or wholesaler. |
22 | (6) "Pharmacies" means all pharmacies governed by chapter 19.1 of title 5, and all |
23 | nonresident pharmacies authorized by law to provide covered drugs to state residents by mail. |
24 | (7) "Wholesaler" means any person, company, corporation or other entity that sells or |
25 | distributes drugs and covered drugs for resale to an entity in the state governed by chapter 19.1 of |
26 | title 5, other than a consumer. |
27 | (8) "Repackager" means an entity that owns or operates an establishment that repacks and |
28 | relabels a product or package containing a covered drug for further sale or for distribution without |
29 | further transaction. |
30 | 21-38-2. Drug take back program. |
31 | (a) Any manufacturer of a covered drug shall: |
32 | (1) Operate a drug take back program approved by the department individually or jointly |
33 | with other manufacturers; |
34 | (2) Enter into an agreement with a drug take back organization which shall operate a drug |
| LC003065 - Page 2 of 6 |
1 | take back program approved by the department; or |
2 | (3) Enter into an agreement with the department to operate a drug take back program on |
3 | its behalf. |
4 | (b) Any manufacturer of a covered drug, individually or jointly, or a drug take back |
5 | organization contracted by a manufacturer of a covered drug shall within ninety (90) days from |
6 | the effective date of this section submit to the department, in a manner and form established by |
7 | the department, a proposed drug take back program that meets, at a minimum, the following |
8 | requirements: |
9 | (1) Certifies the drug take back program will accept all covered drugs regardless of who |
10 | produced them; |
11 | (2) Provides contact information for the person submitting the planned drug take back |
12 | program with whom the department shall direct all inquiries; |
13 | (3) Details a collection system to provide convenient, ongoing collection services to all |
14 | persons seeking to dispose of covered drugs pursuant § 21-38-3; |
15 | (4) Describes other collection methods by which covered drugs will be collected by |
16 | authorized collectors; |
17 | (5) Explains how covered drugs will be safely and securely tracked and handled from |
18 | collection through final disposal and destruction, policies to ensure security and compliance with |
19 | all applicable laws and regulations, including disposal and destruction at a permitted waste |
20 | disposal facility meeting federal requirements; |
21 | (6) Describes the public education and outreach activities that will be undertaken which |
22 | shall include advertising of collection locations on a website and through use of signage and other |
23 | written materials, and how effectiveness will be evaluated; |
24 | (7) Details how the costs of pharmacy collection and other authorized collectors will be |
25 | reimbursed which shall include costs retroactive to the effective date of this chapter, and where |
26 | more than one manufacturer will be involved in the planned drug take back program, a plan for |
27 | the fair and reasonable manner of allocated costs among the participants in such program such |
28 | that the costs paid by each manufacturer is reasonably related to the volume or value of covered |
29 | drugs sold in the state; and |
30 | (8) Provides any further information deemed appropriate by the department. |
31 | (c) Within thirty (30) days of the effective date of this section, each wholesaler that sells |
32 | covered drugs in or into the state shall provide the department with a list of manufacturers that |
33 | produce covered drugs. The department may request updated lists at its discretion. |
34 | (d) A manufacturer, individually or jointly, must pay all administrative and operational |
| LC003065 - Page 3 of 6 |
1 | fees associated with the drug take back program, including the cost of collecting, transporting and |
2 | disposing of covered drugs from pharmacies and other authorized collectors and the recycling or |
3 | disposal, or both, of packing collected with the covered drug. Manufacturers shall also pay costs |
4 | incurred by the state in the administration and enforcement of the drug take back program. |
5 | Exclusive of fines and penalties, the state shall only recover its actual cost of administration and |
6 | enforcement. In instances where manufacturers jointly conduct a drug take back program, the |
7 | costs of administration and enforcement shall be fairly and reasonably allocated such that the |
8 | portion of costs is reasonably related to the volume or value of covered drugs the manufacturers |
9 | sell in the state. No manufacturer may charge a point-of-sale or other fee to consumers, or a fee |
10 | that could be passed on to consumers, to recoup the cost of their drug take back program. |
11 | (e) Within sixty (60) days of receipt of a proposed drug take back program, the |
12 | department, in consultation with the department of environmental management, shall determine |
13 | whether such proposed drug take back program complies with the requirements of this chapter |
14 | and notify the applicant. The department may conduct a noticed public hearing prior to approval. |
15 | If the drug take back program is approved, the department shall notify the applicant in writing. If |
16 | the drug take back program is not approved, the department shall notify the applicant in writing |
17 | and the applicant shall submit a revised drug take back program proposal within thirty (30) days. |
18 | If the department rejects the subsequent proposal, the manufacturer or manufacturers at issue |
19 | shall be out of compliance with this chapter and subject to the enforcement provisions referenced |
20 | in § 21-38-4. The department shall provide, and update annually, on its website a list of all |
21 | manufacturers participating in a drug take back program approved by the department. At least |
22 | every three (3) years, a manufacturer, jointly or individually, or a drug take back organization |
23 | shall update its drug take back program and submit an updated proposal to the department for |
24 | approval. A manufacturer who begins to offer a covered drug in the state after the effective date |
25 | of this chapter, shall provide evidence of joining an existing approved drug take back program or |
26 | submit a proposal for a drug take back program within ninety (90) days following the initial offer |
27 | for sale of a covered drug. Any proposed change to a drug take back program shall be submitted |
28 | in writing and approved by the department prior to any change. Each approved drug take back |
29 | program shall report to the department at a date and manner set by the department. The |
30 | department shall submit an annual report to the governor, speaker of the house of representatives |
31 | and president of the senate by January 1 detailing all program activities, the weight collected by |
32 | each program, a description of collection activities, the name and location of all collection sites, |
33 | public education and outreach activities, an evaluation of the efficacy of the program and each |
34 | collection method, and any manufacturer out of compliance or subject to penalties pursuant to § |
| LC003065 - Page 4 of 6 |
1 | 21-38-4. |
2 | 21-38-3. Collection. |
3 | (a) All pharmacies shall provide for the safe collection of drugs, which shall include: |
4 | (1) Offering drug collection by one or more of the following methods: |
5 | (i) On-site collection, dropbox, or receptacle meeting federal standards; |
6 | (ii) Mail-back collection by prepaid envelopes as authorized by federal law and |
7 | regulation; or |
8 | (iii) Other federal drug enforcement agency approved methods of collection; |
9 | (2) Signage prominently displayed advertising such drug collection to consumers. |
10 | (b) All drug take back program operators shall notify other potential authorized collectors |
11 | of the opportunity to serve as an authorized collector for the drug take back program. |
12 | Participation of authorized collectors besides pharmacies shall be voluntary. |
13 | (c) All costs of pharmacies and other authorized collectors shall be paid or reimbursed by |
14 | the manufacturer, jointly or individually, as part of the drug take back programs required by this |
15 | chapter. |
16 | (d) Pharmacies providing for mail-back collection as part of the drug take back program |
17 | shall provide a voucher for a prepaid envelope upon dispensing a covered drug. Such voucher |
18 | shall include information on drug take back and safe drug disposal methods. |
19 | 21-38-4. Violations. |
20 | Violation of this chapter shall be subject to a schedule of fines to be established by the |
21 | department. Each day in which the violation continues shall constitute a separate violation. |
22 | 21-38-5. Jurisdiction. |
23 | Jurisdiction of all matters pertaining to drug disposal by this chapter is vested exclusively |
24 | in the state. Any provision of any local law or ordinance, or any rule or regulation promulgated |
25 | prior to, or upon the effective date of this section, shall be preempted. |
26 | SECTION 2. This act shall take effect on January 1, 2021. |
======== | |
LC003065 | |
======== | |
| LC003065 - Page 5 of 6 |
EXPLANATION | |
BY THE LEGISLATIVE COUNCIL | |
OF | |
A N A C T | |
RELATING TO FOOD AND DRUGS | |
*** | |
1 | This act would mandate drug manufacturers to establish, fund, and manage a state- |
2 | approved drug take back program for the safe collection and disposal of unused covered drugs. It |
3 | would also provide consumers with pre-approved methods of collection and disposal, free of |
4 | charge to the consumer and pharmacy. |
5 | This act would take effect on January 1, 2021. |
======== | |
LC003065 | |
======== | |
| LC003065 - Page 6 of 6 |