CHAPTER Jus 1600  PROCEDURES FOR PHARMACEUTICAL DRUG COLLECTION AND DISPOSAL PROGRAMS

 

Statutory Authority: RSA 318-E:1

 

PART Jus 1601  PURPOSE AND SCOPE

 

          Jus 1601.01  Purpose.

 

          (a)  The purpose of these rules is to establish uniform procedures and standards for collecting and disposing of expired or unwanted pharmaceutical drugs from individuals in order to:

 

(1)  Provide the public with an environmentally safe, accessible and convenient alternative to disposing of pharmaceutical drugs in the landfill or sewer systems that may later negatively affect the environment; and

 

(2) Encourage individuals to remove expired or unwanted pharmaceutical drugs from their households and residences to reduce access to addictive drugs for accidental or intentional misuse by individuals, especially children, in the home.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

          Jus 1601.02  Scope.  Controlled and non-controlled pharmaceutical drugs collected in accordance with this chapter shall be exempt from the disposal requirements for controlled drugs stipulated in RSA 318-B:17.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

PART Jus 1602  DEFINITIONS

 

          Jus 1602.01  “Collection box” means a secured receptacle with an inner lining, into which pharmaceutical drugs can be deposited and which remains in possession of designated law enforcement officers for the purposes of a collection event.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

          Jus 1602.02  "Collection event" means a one-day program through which the public can safely dispose of unused or expired  pharmaceutical drugs from a household or residence that are no longer wanted or needed by the consumer, at a secure collection site.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

          Jus 1602.03  ”Controlled drugs'' means “controlled drugs” as defined in RSA 318-B:1, VI.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

          Jus 1602.04  “Department” means the department of justice.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

          Jus 1602.05  “Drop box” means a double-locked receptacle with an inner lining into which pharmaceutical drugs are deposited, situated in a police station and constructed in a manner that prevents tampering or access by non-authorized persons.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

          Jus 1602.06  “Inner lining” means a water proof, tamper-evident, and tear resistant lining that shall be capable of sealing immediately upon removal from a receptacle.

 

Source.  #13551, eff 2-2-23

 

         Jus 1602.07  “Law enforcement officer” means any officer of the state or political subdivision of the state whom is empowered by law to conduct investigations of or to make arrests for offenses enumerated in RSA 318-B:2.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23 (formerly Jus 1602.06)

 

          Jus 1602.08 “Pharmaceutical drug” means “pharmaceutical drug” as defined in RSA 318-E:1, I.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23 (formerly Jus 1602.07)

 

          Jus 1602.09  “Sharps” means needles, syringes, or lancets, individually or collectively.

 

Source.  #13551, eff 2-2-23

 

PART Jus 1603  PERMANENT DROP BOXES

 

          Jus 1603.01  Police Station Permanent Drop Boxes.

 

          (a)  The chief law enforcement officer of an agency seeking to place a permanent drop box in a police station shall first request and obtain written authorization, pursuant to 21 C.F.R. § 1317, from the:

 

Drug Enforcement Administration – Office of Diversion Control

NEW ENGLAND DIVISION

JFK Federal Building

15 New Sudbury Street, Room E-400

Boston, MA 02203

(617) 557-2191

 

          (b)  A permanent drop box shall only be located in a police station and shall remain in the custody of law enforcement at all times.

 

          (c)  The drop box shall be placed in a location that is accessible to the public and under constant video recording surveillance.

 

          (d)  The drop box shall be securely mounted to a wall or floor to prohibit removal of the box or retrieval of the contents from within the box without a key.

 

          (e)  The drop box shall be clearly marked with the following information:

 

“Pharmaceutical drugs, to include controlled, non-controlled, and over-the-counter drugs from households and residences only;

 

Pharmaceutical drugs may be disposed of in the original containers or in a sealed plastic bag;

 

Liquid pharmaceuticals shall remain in the original container; and

 

No needles, syringes, or lancets shall be placed in the dropbox”.

 

          (f)  Individuals shall place unused pharmaceutical drugs directly into the collection box.

 

          (g) Individuals utilizing the drop box in accordance with this chapter shall not be questioned or required to disclose personal identification.

 

          (h)  The chief law enforcement officer of an agency maintaining a permanent drop box shall designate 2 law enforcement officers who shall be the sole possessors of keys to the drop box.  Each shall have a separate and distinct key, with both keys required in order to access the drop box.

 

          (i)  The designated law enforcement officers in (h) above shall both be present when removing the contents of the drop box. In the event that one or both officers are unavailable to be present when removing the contents of the drop box, the chief law enforcement officer may designate one or more replacement officers to be present.

 

          (j)  The contents of the drop box shall remain in a secured area of the law enforcement agency until they are disposed of in accordance with the procedures outlined in Jus 1605.

 

          (k)  The chief law enforcement officer of an agency maintaining a permanent drop box shall provide written notification to the attorney general that the agency has established a program in accordance with these rules.  The written notification shall be sent to:

 

Department of Justice

Criminal Bureau

33 Capitol Street

Concord, NH  03301

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

          Jus 1603.02  Pharmaceutical Drugs Collected in Permanent Drop Box.

 

          (a)  Collected pharmaceutical drugs shall remain secured until ready for disposal.

 

          (b)  An inventory of collected pharmaceutical drugs shall not be required by these rules.

 

          (c)  Collected pharmaceutical drugs shall not be resold or reused.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

PART Jus 1604  PERIODIC OR ONE-TIME PHARMACEUTICAL DRUG TAKE-BACK EVENTS

 

          Jus 1604.01  Participation.

 

          (a)  A pharmaceutical drug take-back collection event established by any government or private entity, pursuant to RSA 318-E shall be voluntary.

 

          (b)  If a government or private entity establishes a pharmaceutical drug take back collection event, it shall be done in accordance with these rules and in conjunction with a participating chief law enforcement officer of a law enforcement agency.

 

          (c)  The chief law enforcement officer of the law enforcement agency seeking to establish a collection event in conjunction with a government entity or private entity, shall first request and obtain written authorization, pursuant to 21 C.F.R. § 1317, from the:

 

Drug Enforcement Administration – Office of Diversion Control

NEW ENGLAND DIVISION

JFK Federal Building

15 New Sudbury Street, Room E-400

Boston, MA 02203

(617) 557-2191

 

          (d)  The chief law enforcement officer of a law enforcement agency establishing  a pharmaceutical drug take-back collection event in conjunction with a government entity or private entity, shall provide written notification to the attorney general that the agency has established an event in accordance with these rules. Written notification shall be sent to:

 

Department of Justice

Criminal Bureau

33 Capitol Street

Concord, NH  03301

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

          Jus 1604.02  Standards and Procedures for the Collection Event.

 

          (a)  At least 2 law enforcement officers designated by the chief law enforcement officer of an agency participating in a collection event shall, at all times, be present and responsible for supervising the collection event.

 

          (b)  The law enforcement officers referred to in paragraph (a) shall, at all times, have sole control over, and sole possession of, all pharmaceutical drugs collected, and the collection box(es) in which the collected pharmaceutical drugs are stored.

 

          (c)  Individuals disposing of unused pharmaceutical drugs shall place them directly into the collection box.  Law enforcement officers shall not directly handle the surrendered pharmaceutical drugs at any time.

 

          (d)  Individuals utilizing the collection event in accordance with this chapter shall not be questioned or required to disclose personal identification.

 

          (e)  Only controlled and non-controlled pharmaceutical drugs, and over-the-counter drugs from a household or residence shall be collected.

 

          (f)  No sharps shall be placed in the collection box. A bulk sharps disposal container may be provided at each collection event for the disposal of sharps.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

          Jus 1604.03  Removal of Collection Boxes.

 

          (a)  At the conclusion of the collection event, law enforcement officers referred to in Jus 1604.02(a) shall be responsible for removing the collection box(es) and bulk sharps disposal container, if any, the same day from the event location for disposal in accordance with the procedures outlined in Jus 1605. 

 

          (b)  Collected pharmaceutical drugs shall remain secured until ready for disposal. 

 

          (c)  An inventory of collected pharmaceutical drugs shall not be required.

 

          (d)  Collected pharmaceutical drugs shall not be resold or reused.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

PART Jus 1605  DISPOSAL OF PHARMACEUTICAL DRUGS

 

          Jus 1605.01  Procedure for Disposal of  Pharmaceutical Drugs.

 

          (a)  Pharmaceutical drugs collected pursuant to Jus 1603 or Jus 1604 shall be destroyed via incineration at a solid waste disposal facility that is authorized to accept the waste under the destination state's laws and rules.

 

          (b)  Pharmaceutical drugs collected pursuant to Jus 1603 or Jus 1604 shall remain in a secured area of the designated law enforcement area until the destruction of the material is witnessed by a designated law enforcement officer. 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

          Jus 1605.02  Documentation of Disposal of Pharmaceutical Drugs.

 

          (a)  The designated law enforcement officer in Jus 1605.01(b) above shall document the following:

 

(1)  The date and location of the collection event or location of the permanent drop box;

 

(2)  The weight of the collected pharmaceutical drugs;

 

(3)  The date and location where the collected pharmaceutical drugs were destroyed; and

 

(4)  The name(s) of the designated participating law enforcement officers, including the name of the law enforcement officer that witnessed the destruction pursuant to Jus 1605.01 (b) and either:

 

a. The names of the 2 law enforcement officers identified under Jus 1604.02(a) for collection events; or

 

b. The names of the 2 law enforcement officers designated pursuant to Jus 1603.01(i) who are present for the removal of the contents of a drop box, whichever is applicable.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

PART Jus 1606  RECORDKEEPING

 

          Jus 1606.01  Records.

 

          (a)  The law enforcement agency participating in a program under Jus 1603 or Jus 1604 shall retain a copy of the documentation of the disposal of pharmaceutical drugs, as required by Jus 1605, for a period not less than 5 years.

 

          (b)  Each agency participating in a program under this chapter shall develop and maintain a written manual of policies and procedures consistent with these rules.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

PART Jus 1607  WAIVERS

 

          Jus 1607.01  Waiver Request.

 

          (a) The chief law enforcement officer of a law enforcement agency seeking to establish a pharmaceutical drug take-back program in conjunction with a government entity or private entity, may request a waiver of specific rules outlined in this chapter in accordance with (c) below.

 

          (b)  The chief law enforcement officer requesting a waiver shall submit the information set forth in (c) in writing to the department at:

 

Department of Justice

Criminal Bureau

33 Capitol Street

Concord, NH  03301

 

          (c)  The waiver request shall set forth the following information:

 

(1)  A description of the pharmaceutical drug take-back program to which the waiver request relates;

(2)  A reference to the specific section of the rules for which a waiver is being sought;

 

(3)  A full and detailed explanation of why a waiver is necessary;

 

(4)  Whether the waiver is needed for a limited duration and, if so, an estimate of when the waiver will no longer be needed;

 

(5)  A full explanation with supporting data of the alternatives, if any, proposed to be implemented or used in lieu of the rule requirements; and

 

(6)  A full explanation of how the waiver, including any proposed alternatives:

 

a.  Would be consistent with the intent of RSA 318, RSA 318-B, and RSA 318-E; and

 

b. Would adequately protect human health and the environment and prevent the illegal diversion of collected pharmaceutical drugs.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

          Jus 1607.02  Incomplete Waiver Requests.  Any waiver request that is received by the department that does not conform with Jus 1607.01(c) shall be deemed incomplete and returned to the requestor with an explanation.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

          Jus 1607.03  Waiver Response.

 

          (a)  The department shall issue a written response to a request for a waiver within 30 days of receiving a complete request. If the waiver is denied, the denial shall specifically set forth the reason(s) for the denial.

 

          (b)  The Department, in consultation with the Pharmacy Board, Department of Environmental Services, and the department of Safety,  shall grant a waiver if it determines that the intent of RSA 318, 318-B, and 318-E will be met, human health and the environment will be protected, and the illegal diversion of collected pharmaceutical drugs will be prevented. In granting the waiver, the department shall impose such conditions, including time limitations, as the department deems necessary to ensure that the activities conducted pursuant to the waiver will be consistent with the intent of RSA 318, 318-B, and 318-E.

 

          (c)  No waiver shall be granted to any requirement specified in statute unless the statute expressly allows such requirement to be waived.

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23

 

PART Jus 1608  PROCEDURES FOR WAIVERS FROM THE DEA

 

          Jus 1608.01  Periodic or One-time Pharmaceutical Take-Back Collection Events.

 

          (a)  If a government or private entity establishes a pharmaceutical drug-take-back collection event, it shall be done in conjunction with a participating chief law enforcement officer of a law enforcement agency.

 

          (b)  A periodic or one-time pharmaceutical take-back collection event shall be exempt from these rules if within 30 days before the scheduled event:

 

(1)  The chief law enforcement officer requests a written waiver from:

 

Drug Enforcement Administration-Office of Diversion Control

NEW ENGLAND DIVISION

JFK Federal Building

15 New Sudbury Street, Room E-400

Boston, MA   02203

(617) 557-2191

 

(2)  After receipt of the waiver from the DEA, the chief law enforcement officer certifies in writing to the attorney general that the periodic or one-time pharmaceutical take-back collection event shall be compliant with the Northeast Recycling Council’s:

 

a.  “Best Management Practices Operating Unwanted Medication Collections – A Legal & Safe Approach”, November 2008 edition;

 

b.  “Holding an Unwanted Medication Collection as Part of a Household Hazardous Waste Event – A Legal and Safe Approach”, September 2006 edition; and

 

c.  Operating Unwanted Medication Collections - A Legal & Safe Approach”, September 2006 edition.

 

          (c)  The certification referred to in (b)(2) above, shall be signed by the chief law enforcement officer and shall be sent to:

 

Department of Justice

Criminal Bureau

33 Capitol Street

Concord, NH  03301

 

 

Source.  #10177, eff 8-23-12; ss by #13551, eff 2-2-23


APPENDIX

 

Rule

Specific State and Federal Statutes the Rule Implements

 

 

Jus 1600

RSA 318-E:1

 

 

 

 

 


 

APPENDIX B

 

Rule

Title

Obtain at:

Jus 1608.01 (b)(2)

“Best Management Practices for Holding Unwanted Medication Collections, A Legal & Safe Approach for Community Pharmacies, Northeast Recycling Council, November 2008”

 “Holding an Unwanted Medication Collection as Part of a Household Hazardous Waste Event – A Legal and Safe Approach, Northeast Recycling Council, September 2006”

“Operating Unwanted Medication Collections – A Legal & Safe Approach, Northeast Recycling Council, September 2006”

 

https://nerc.org/documents/unwanted_medication_collection_bmp_11_08.pdf

 

Price: Free

 

 

 

https://nerc.org/documents/holding_unwanted_medications_collection_final_2006.pdf

 

Price: Free

 

 

https://nerc.org/documents/operating_unwanted_medication_collections_final_2006.pdf

 

Price: Free