Exhibit E 6 CCR 1010-23 Take-Back Program Regulation.pdf

DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT

Division of Environmental Health and Sustainability

RULES AND REGULATIONS GOVERNING THE COLORADO HOUSEHOLD MEDICATION AND

HOUSEHOLD SHARPS TAKE-BACK PROGRAM

6 CCR 1010-23

[Editor’s Notes follow the text of the rules at the end of this CCR Document.]

23.1 Authority

This regulation is adopted pursuant to the authority in Section 25-15-328(7), C.R.S., and is intended to be consistent with the requirements of the State Administrative Procedures Act, Section 24-4-101, et seq., C.R.S. Where there is a conflict between the requirements of the State Administrative Procedures Act and Section 25-15-328, C.R.S., the provisions of Section 25-15-328, C.R.S. shall prevail.

23.2 Scope and Purpose

A. This regulation governs the Colorado Household Medication and Household Sharps Take-Back Program (program) established in Section 25-15-328, C.R.S. This regulation establishes:

1. Rules pertaining to department-approved program participants voluntarily engaging in the collection of household medications or household sharps;

2. Rules for department-approved collectors of household medications;

3. Rules for the acquisition and transportation of household medications from department-approved collectors to department-approved disposal locations;

4. Rules for the destruction of household medications at approved disposal locations;

5. Rules for department-approved collectors of household sharps;

6. Rules for the acquisition of household sharps from department-approved collectors and individuals by department-approved transporters; and

7. Rules for the treatment and disposal of household sharps.

B. This regulation does not apply to:

1. The authority to collect and reuse medications pursuant to Section 12-42.5-133, C.R.S.;

2. Wastes generated by non-household waste generators subject to Section 13 of the Regulations Pertaining to Solid Waste Sites and Facilities, 6 CCR 1007-2;

3. Wastes generated by non-household waste generators subject to the Hazardous Waste Regulations, 6 CCR 1007-3;

4. The operation of other household medication and household sharps take-back and disposal programs regulated by the department;

CODE OF COLORADO REGULATIONS 6 CCR 1010-23

Division of Environmental Health and Sustainability

5. Generators of household medications and household sharps; or

6. Schedule I controlled substances as defined in U.S. Department of Justice, Drug Enforcement Administration, 21 Code of Federal Regulations (CFR) § 1308.11, Schedule of Controlled Substances, Schedule I; revised as of April 1, 2019, and hereby incorporated by reference.

C. Persons who comply with this regulation may participate in the program. Department-contracted participants who incur costs associated with the collection, transportation, treatment, disposal, or destruction of household medications and household sharps pursuant to the program may apply to the department for reimbursement.

23.3 Applicability

A. The provisions of this section shall be applicable to the Colorado Household Medication and Household Sharps Take-Back Program as created by Section 25-15-328, C.R.S.

B. Participation in the Colorado Household Medication and Household Sharps Take-Back Program is voluntary.

C. Participants in the Colorado Household Medication and Household Sharps Take-Back Program include: department-approved collectors, transporters, treatment facilities, and disposal locations.

D. These regulations shall not limit the powers and duties of local governments to issue such orders and adopt regulations as stringent or more stringent than the provisions contained herein.

23.4 Definitions

A. For the purpose of these rules and regulations:

1. Collection means to receive household medications from individuals for the purpose of destruction. If a household medication is a controlled substance, collection means to receive a controlled substance for the purpose of destruction from an ultimate user or an individual lawfully entitled to dispose of an ultimate user decedent’s property; and means to receive household sharps from individuals for the purpose of treatment and disposal.

2. Collector means a DEA-registrant or law enforcement agency approved by the department for the collection of household medications; and an entity approved by the department for the collection of household sharps.

3. Colorado Household Medication and Household Sharps Take-Back Program or program means the program established in Section 25-15-328, C.R.S to facilitate the safe and effective collection, transportation, destruction, and disposal of household medications;

and to facilitate the safe and effective collection, transportation, treatment and disposal of household sharps.

4. Commission means the Solid and Hazardous Waste Commission created pursuant to Section 25-15-302, C.R.S.

5. Common Carrier means a for-hire carrier that holds itself out to serve the general public at reasonable rates and without discrimination.

6. Contract Carrier means a for-hire interstate operator which offers transportation services to certain shippers under contracts.

7. Controlled Substance means a drug or other substance, or immediate precursor, included in schedule II - V and listed in U.S. Department of Justice, Drug Enforcement Administration, 21 CFR §§ 1308.12 through 1308.15, Schedules of Controlled Substances; revised as of April 1, 2019, and hereby incorporated by reference.

8. DEA means the Drug Enforcement Administration and its authorized agents and employees.

9. DEA Registrant or Registrant means any person who is registered pursuant to U.S.

Department of Justice, Drug Enforcement Administration, 21 CFR § 1301.11(a), Persons required to register; revised as of April 1, 2019, and hereby incorporated by reference.

10. Department means the Colorado Department of Public Health and Environment and its authorized agents and employees.

11. Disposal Location means a site approved by the department where household medications are destroyed in compliance with applicable laws and rendered non-retrievable and cannot be diverted for illicit purposes; and means a site approved by the department where treated household sharps are disposed in compliance with applicable laws.

12. Distribute means to deliver (other than by administering or dispensing) a controlled substance or to deliver (other than by administering or dispensing) a listed chemical designated in U.S. Department of Justice, Drug Enforcement Administration, 21 CFR § 1310.02, Substances covered; revised as of April 1, 2019, and hereby incorporated by reference.

13. Distributor means a person who delivers (other than by administering or dispensing) a controlled substance or delivers (other than by administering or dispensing) a listed chemical designated in U.S. Department of Justice, Drug Enforcement Administration, 21 CFR § 1310.02, Substances covered, revised as of April 1, 2019, and hereby incorporated by reference.

14. Employee means an individual directly paid by a program participant; subject to direct oversight by a program participant; required, as a condition of employment, to follow a program participant’s procedures and guidelines pertaining to the handling of household medications, including controlled substances, or pertaining to the handling of household sharps; subject to receive a performance rating or performance evaluation on a regular/routine basis from a program participant; subject to disciplinary action by a program participant; and required to render services at the site of a program participant’s covered activities. At a law enforcement agency collector an employee may, at the agency’s discretion, be a paid or unpaid reserve officer as defined pursuant to 16-2.5- 110, C.R.S.

15. Household Medications means controlled substances approved for collection by federal law, prescription drugs, and over-the-counter medications in the possession of an individual, not generated by a commercial or industrial entity.

16. Household Medication Take-Back Event means a scheduled, organized occasion of limited duration, managed by a law enforcement agency for the collection of household medications, including controlled substances collected from ultimate users and individuals lawfully entitled to dispose of an ultimate user decedent’s property.

17. Household Sharps means blood-sampling lancets, needles, and needle-containing devices used to inject medications including syringes, auto injectors, and injection cartridges in the possession of an individual, not generated by a commercial or industrial entity.

18. Law Enforcement Agency means, but is not limited to, a municipal, tribal, university, or college police department; a county sheriff’s office; a district attorney’s office; a county coroner’s office; a town marshal’s office; the Colorado Department of Public Safety; and the Colorado Department of Corrections.

19. Law Enforcement Officer means an individual who:

a. Is an employee of either a law enforcement agency or law enforcement component of a federal agency;

b. Is under the direction and control of a federal, state, tribal, or local government;

c. Acts in the course of the law enforcement officer’s official duty; and

d. Is duly sworn and given the authority by a federal, state, tribal, or local government to carry firearms, execute and serve warrants, make arrests without warrant, and make seizures of property.

20. Non-retrievable means, for the purpose of destruction, the condition or state to which household medications shall be rendered following a process that permanently alters the household medications’ physical or chemical condition or state through irreversible means and thereby renders the household medications unavailable and unusable for all practical purposes, thus preventing their diversion to illicit purposes. The process to achieve a non-retrievable condition or state may be unique to a household medication’s chemical or physical properties. A controlled substance is considered non-retrievable when permanently altered in such manner and it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue.

21. On-site means located on or at the physical premises of the registrant’s registered location. A controlled substance is destroyed on-site when destruction occurs on the physical premises of the destroying registrant’s registered location. A hospital/clinic has an on-site pharmacy when it has a pharmacy located on the physical premises of the registrant’s registered location.

22. Reverse Distribute means to acquire controlled substances from another registrant or law enforcement for the purpose of:

a. Return to the registered manufacturer or another registrant authorized by manufacturer to accept returns on the manufacturer’s behalf; or

b. Destruction.

23. Reverse Distributor means a person registered with the Drug Enforcement Administration to reverse distribute controlled substances.

24. Transporter means any entity approved by the department to acquire household medications from approved collectors for disposal; and means any entity approved by the department to acquire household sharps from approved collectors or individuals for treatment and disposal.

25. Treatment Facility means a department-approved location where household sharps are rendered non-infectious.

26. Ultimate User means an individual who has lawfully obtained, and who possesses, a controlled substance for the individual’s own use or for the use of a member of the individual’s household or for an animal owned by the individual or by a member of the individual’s household.

23.5 Standards for Department-Approved Program Participants

A. All program participants shall comply with requirements of federal, state, tribal, and local laws and regulations.

Part I Household Medications

23.6 Specific Standards for Household Medication Department-Approved Collectors, Transporters, and Disposal Locations

23.6.1 Household Medication Collectors

A. In order to collect household medications as a department-approved participant in the program, a collector shall:

1. Be a law enforcement agency; or a DEA-registered location of a retail pharmacy or a hospital/clinic with an on-site pharmacy, whose registrations have been modified consistent with DEA requirements described in U.S. Department of Justice, Drug Enforcement Administration, 21 CFR § 1301.51, Modification in registration; revised as of April 1, 2019, and hereby incorporated by reference, to authorize collection of controlled substances.

2. Have an application form approved by the department.

3. Designate an individual responsible for oversight of household medication collection activities.

4. Develop, implement, and maintain on site in an easily retrievable format a Medical Waste Management Plan containing, at a minimum, the following elements:

a. Procedures for household medication identification, collection, packaging, storage, transport and disposal;

b. A contingency plan for spills and releases;

c. Employee and volunteer training procedures;

d. Designation of an individual or individuals responsible for implementing the plan;

and

e. Recordkeeping methods.

23.6.2 Household Medication Transporters

A. In order to acquire household medications from collectors as a department-approved participant in the program and transport them to disposal locations for destruction, or transfer them to another registrant for subsequent destruction, a transporter shall be:

1. A reverse distributor or distributor under contract or other written, signed service agreement with the department if acquiring household medications from a DEA-registered collector by on-site pick-up or by common carrier or contract carrier delivery; or

2. A reverse distributor under contract or other written, signed service agreement with the department if acquiring household medications from a law enforcement agency collector by on-site pick-up or by common carrier or contract carrier delivery.

23.6.3 Household Medication Disposal Locations

A. In order to destroy collected household medications as a department-approved participant in the program, a disposal location shall:

1. Utilize a method of destruction that renders household medications non-retrievable; and

2. Comply with applicable federal, state, tribal, and local laws and regulations.

23.7 Allowable Household Medication Collection Methods

23.7.1 DEA-Registered Household Medication Collectors

A. DEA-registered collectors participating in the program may collect household medications, including controlled substances collected from ultimate users, utilizing the following collection method:

1. Collection receptacles and inner liners in accordance with Sections 23.8 and 23.9.

23.7.2 Law Enforcement Agency Household Medication Collectors

A. Law enforcement agency collectors participating in the program may collect household medications in the course of official duties, including controlled substances collected from ultimate users, utilizing the following collection methods:

1. Collection receptacles and inner liners in accordance with Sections 23.8 and 23.9; and/or

2. Take-back events in accordance with Section 23.10.

23.8 Household Medication Collection Receptacle Requirements

A. Collection receptacles shall be securely placed and maintained either (1) inside a DEA-registered collector’s location, or (2) inside a law enforcement agency collector’s physical location.

B. For collection receptacles located inside a DEA-registered collector’s location:

1. At a retail pharmacy, receptacles shall be located in an area accessible to the public and in the immediate proximity of a designated area where controlled substances are stored, and at which an employee is present (e.g., can be seen from the pharmacy counter); and

2. At a hospital/clinic, receptacles shall be located in an area accessible to the public and regularly monitored by employees, and shall not be located in the proximity of any area where emergency or urgent care is provided.

C. For collection receptacles located inside a law enforcement agency collector’s location, receptacles shall be located in an area monitored by employees or law enforcement officers.

D. A collection receptacle shall meet the following design specifications:

1. At a DEA-registered collector’s location, be securely fastened to a permanent structure so that it cannot be removed;

2. Be a securely locked, substantially constructed container with a permanent outer container and a removable inner liner as specified in Section 23.9;

3. Include a small opening in the outer container that allows contents to be added to the inner liner, but does not allow removal of the inner liner's contents;

4. Prominently display a sign on the outer container indicating that only Schedule II-V controlled and non-controlled substances are acceptable substances. Schedule I controlled substances, controlled substances that are not lawfully possessed by the ultimate user, and other illicit or dangerous substances are not permitted; and

5. Except at a law enforcement agency location, the small opening in the outer container of the collection receptacle shall be locked or made otherwise inaccessible to the public when an employee is not present (e.g., when a pharmacy is closed).

E. Except at a law enforcement agency location specifically authorized by the department, once household medications have been deposited into a collection receptacle, the household medications shall not be counted, sorted, inventoried, or otherwise individually handled.

F. Only those controlled substances listed in Schedule II, III, IV, or V that are lawfully possessed by an ultimate user or other authorized non-registrant individual may be collected along with other household medications that are non-controlled substances. Controlled and non-controlled substances may be collected together and be comingled.

G. Law enforcement agency collectors may allow ultimate users and other authorized non-registrant individuals in lawful possession of a controlled substance in Schedule II, III, IV, or V to transfer such substances and other household medications to a law enforcement officer or law enforcement agency employee for immediate deposit in a collection receptacle, if the collection receptacle is located in an area not accessible to the public.

23.9 Household Medication Collection Receptacle Inner Liner Requirements

A. The inner liner used in a collection receptacle shall meet the following requirements:

1. The inner liner shall be opaque, waterproof, tamper-evident, and tear-resistant;

2. The inner liner shall be removable and sealable immediately upon removal without emptying or touching the contents;

3. The contents of the inner liner shall not be viewable from the outside when sealed;

4. The size of the inner liner shall be clearly marked on the outside of the liner (e.g., 5-gallon, 10-gallon, etc.); and

5. The inner liner shall bear a permanent, unique identification number that enables the inner liner to be tracked in accordance with Section 23.16.2(A) and (B).

B. Access to the inner liner shall be restricted to employees of a DEA-registered collector or employees of a law enforcement agency collector.

C. Installation and removal of the inner liner shall be performed by:

1. Two employees of a DEA-registered collector; or

2. Unless otherwise approved by the department, two employees of a law enforcement agency collector.

D. The inner liner shall be sealed immediately upon removal from the permanent outer container of the collection receptacle and the sealed inner liner shall not be opened, x-rayed, analyzed, or otherwise penetrated. The inner liner shall be sealed by:

1. Two employees of a DEA-registered collector; or

2. Unless otherwise approved by the department, two employees of a law enforcement agency collector.

23.10 Household Medication Take-Back Events

A. A law enforcement agency may conduct a take-back event and collect household medications, including controlled substances collected from ultimate users and individuals lawfully entitled to dispose of an ultimate user decedent's property. A law enforcement agency may partner with other persons or entities to hold a collection take-back event in accordance with this Section.

B. A law enforcement agency shall appoint at a minimum one law enforcement officer employed by the agency to oversee the collection. Law enforcement officers employed by the law enforcement agency conducting a take-back event shall maintain control and custody of the household medications from the time they are collected until secure transfer, storage, or destruction has occurred.

C. A law enforcement agency may conduct a take-back event at its physical location or at another location, provided the law enforcement officer(s) overseeing the collection are able to maintain custody and control of the household medications in accordance with this Section.

D. A collection receptacle, as described in Section 23.8 and Section 23.9, may be used at a take-back event for the collection of household medications.

E. If a collection receptacle is not used at a take-back event, collected household medications shall be placed in an opaque, waterproof, tamper-evident, and tear-resistant bag bearing the markings required for inner liners as described in Sections 23.9(A)(4) and (5).

F. Only those controlled substances listed in Schedule II, III, IV, or V that are lawfully possessed by an ultimate user or individual entitled to dispose of an ultimate user decedent's property may be collected. Controlled and non-controlled substances may be collected together and be comingled.

G. Only ultimate users and individuals entitled to dispose of an ultimate user decedent's property in lawful possession of a controlled substance in Schedule II, III, IV, or V may transfer such substances to the law enforcement officer described in Section 23.10(B) during the take-back event. No other individual may handle the controlled substances at any time.

23.11 Disposal of Collected Household Medications

23.11.1 DEA-Registered Household Medication Collectors

A. DEA-registered collectors shall dispose of collected household medications in the following manner:

1. Upon inner liner removal from the permanent outer container of a collection receptacle, the sealed inner liner and its contents shall be:

a. Sent by two employees to a transporter’s registered location by common carrier or contract carrier delivery; or

b. Transferred by two employees to a transporter by on-site pick-up at the DEA-registered collector’s location for transport to the transporter’s registered location or transport to a disposal location.

2. A sealed inner liner and its contents shall be placed into secure storage by two employees at the DEA-registered collector’s location, in accordance with Section 23.15.2., until prompt delivery or transfer to a transporter can occur. In no case shall a sealed inner liner be stored at the DEA-registered collector’s location for more than 90-days.

23.11.2 Law Enforcement Agency Household Medication Collectors

A. Law enforcement agency collectors shall dispose of household medications collected at their physical locations in the following manner:

1. Sealed inner liners and their contents removed from collection receptacles and opaque, waterproof, tamper-evident, and tear-resistant bags containing household medications collected at take-back events through means other than a collection receptacle shall be:

a. Sent by two, unless otherwise approved by the department, law enforcement agency employees, to a transporter’s registered location by common carrier or contract carrier delivery; or

b. Transferred by two, unless otherwise approved by the department, law enforcement agency employees to a transporter by on-site pick-up at the law enforcement agency collector’s location for transport to the transporter’s registered location or transport to a disposal location.

2. Sealed inner liners and their contents and opaque, waterproof, tamper evident and tear resistant bags and their contents shall be placed into secure storage at the law enforcement agency by two, unless otherwise approved by the department, law enforcement agency employees, in accordance with Section 23.15.3, until prompt delivery or transfer to a transporter can occur. In no case shall sealed inner liners or opaque, waterproof, tamper-evident, and tear-resistant bags be stored at the law enforcement agency collector’s location for more than 90-days.

B. Law enforcement agency collectors shall dispose of household medications collected at take-back events held at sites other than the agencies’ physical locations in the following manner:

1. Sealed inner liners and their contents removed from collection receptacles and opaque, waterproof, tamper-evident, and tear-resistant bags containing household medications collected at take-back events through means other than a collection receptacle shall be:

a. Transferred by the law enforcement officer described in Section 23.10(B) to a transporter by pick-up at the take-back event site for transport to the transporter’s registered location or transport to a disposal location; or

b. Transported by the law enforcement officer described in Section 23.10(B) to the law enforcement agency’s physical location for disposal in accordance with Section 23.11.2(A).

23.12 Transporter Acquisition of Household Medications from Collectors

23.12.1 Authorized Household Medication Acquisition by Reverse Distributors

A. Reverse distributors participating in the program as transporters are authorized to acquire household medications, including controlled substances collected from ultimate users, from DEA-registered collectors, law enforcement collectors, and law enforcement take-back event locations.

23.12.2 Authorized Household Medication Acquisition by Distributors

A. Distributors participating in the program as transporters are authorized to acquire household medications, including controlled substances collected from ultimate users, from DEA-registered collectors.

23.12.3 Household Medication Acquisition Methods

A. Transporters that acquire household medications in accordance with Sections 23.12.1(A) and 23.12.2(A) are authorized to utilize only the following methods:

1. On-site pick-up.

a. Household medications acquired by on-site pick-up shall be transported to the transporter’s registered location, to a disposal location, or to another registrant for subsequent destruction. Transportation shall be directly to the transporter’s registered location, to a disposal location, or to another registrant for subsequent destruction (the substances shall be constantly moving towards their destination and unnecessary or unrelated stops and stops of an extended duration shall not occur).

b. Upon transfer of household medications acquired by on-site pick-up to the transporter’s registered location, household medications shall be immediately stored in a manner consistent with the security requirements for Schedule II controlled substances and in accordance with the security controls in Section 23.15.4(A) until timely destruction occurs.

2. Delivery by common carrier or contract carrier.

a. Delivery to the transporter by common carrier or contract carrier may only be made to the transporter at the transporter’s registered location. Once in route, such deliveries may not be re-routed to any other location or person, regardless of registration status.

b. All common carrier or contract carrier deliveries of household medications to a transporter shall be personally received by an employee of the transporter at the registered location.

c. Upon acquisition of household medications by common carrier or contract carrier delivery, the transporter shall immediately store the household medications in a manner consistent with the security requirements for Schedule II controlled substances, in accordance with the physical security controls in Section 23.15.4(A) until timely destruction occurs.

23.12.4 Timely Destruction of Acquired Household Medications

A. A transporter shall destroy or cause the destruction of acquired household medications no later than 30 calendar days after acquisition.

23.13 Transporter Procedures for Destruction of Acquired Household Medications

23.13.1 Destruction at Transporter’s Registered Location Acquiring Household Medications

A. If a transporter’s registered location acquiring household medications by on-site pick-up or delivery by common or contract carrier is a disposal location, the following procedures shall be used if household medications are destroyed on-site:

1. Two employees of the transporter shall handle or observe the handling of the household medications until destruction has occurred; and

2. Two employees of the transporter shall personally witness the destruction of the household medications until all are rendered non-retrievable.

23.13.2 Household Medication Transport to a Registered Disposal Location for Destruction

A. If a transporter does not destroy acquired medications at their registered location as described in Section 23.13.1(A), another registered location with destruction capabilities may serve as the disposal location. Household medications shall be transported to the registered disposal location either from a transporter’s registered location that acquired medications by on-site pick-up or delivery by common or contract carrier, or directly from a collector if acquired by on-site pick-up, using the following procedures:

1. Transportation shall be directly to the registered disposal location (the household medications shall be constantly moving towards their final location and unnecessary or unrelated stops and stops of an extended duration shall not occur);

2. Two employees of the transporter shall accompany the household medications to the registered disposal location; and

3. Two employees of the transporter shall load and unload or observe the loading and unloading of the household medications until transfer is complete.

23.13.3 Household Medication Transport to a Non-Registered Disposal Location for Destruction

A. If a transporter does not destroy acquired medications at their registered location as described in Section 23.13.1(A), a non-registered disposal location may be used for destruction. Household medications shall be transported to the non-registered disposal location either from a transporter’s registered location that acquired medications through on-site pick-up or delivery by common or contract carrier, or directly from a collector if acquired by on-site pick-up, using the following procedures:

1. Transportation shall be directly to the non-registered disposal location (the household medications shall be constantly moving towards their final disposal location and unnecessary or unrelated stops and stops of an extended duration shall not occur);

2. Two employees of the transporter shall accompany the household medications to the non-registered disposal location;

3. Two employees of the transporter shall load and unload or observe the loading and unloading of the household medications;

4. Two employees of the transporter shall handle or observe the handling of any household medications until all are rendered non-retrievable; and

5. Two employees of the transporter shall personally witness the destruction of the household medications until all are rendered non-retrievable.

23.13.4 Household Medication Transport to Another Registered Location for Subsequent Destruction

A. If a transporter does not destroy acquired medications at their registered location as described in Section 23.13.1(A), the medications may be transferred to another registered location that is not a disposal location, for subsequent destruction at a registered or non-registered disposal location.

Household medications shall be transported to the registered location either from a transporter’s registered location that acquired medications by on-site pick-up or delivery by common or contract carrier, or directly from a collector if acquired by on-site pick-up, using the following procedures:

1. Transportation shall be directly to the registered location (the household medications shall be constantly moving towards their final location and unnecessary or unrelated stops and stops of an extended duration shall not occur);

2. Two employees of the transporter shall accompany the household medications to the registered location; and

3. Two employees of the transporter shall load and unload or observe the loading and unloading of the household medications until transfer is complete.

23.14 Methods of Household Medication Destruction

A. All household medications to be destroyed pursuant to Section 23.13 shall be destroyed in compliance with applicable federal, state, tribal, and local laws and regulations.

B. The method of destruction shall be sufficient to render household medications, including all controlled substances that may be present, non-retrievable in order to prevent diversion to illicit purposes and to protect the public health and safety.

23.15 Security Requirements

23.15.1 Employee Status

A. Participants in the program shall not employ, as an agent or employee who has access to or influence over household medications acquired by collection, any individual who has been convicted of any felony offense relating to controlled substances; and in the case of DEA-registered participants, any individual who, at any time, had an application for registration with DEA denied, had a DEA registration revoked or suspended, or has surrendered a DEA registration for cause. For purposes of this subsection, “for cause” means in lieu of, or as a consequence of, any federal or State administrative, civil, or criminal action resulting from an investigation of the individual's handling of controlled substances.

23.15.2 Physical Security Controls for DEA-Registered Household Medication Collectors

A. DEA-registered collectors shall store sealed inner liners containing household medications in a securely locked, substantially constructed cabinet or a securely locked room with controlled access.

23.15.3 Physical Security Controls for Law Enforcement Agency Household Medication Collectors

A. Law enforcement agency collectors shall store sealed inner liners and opaque, waterproof, tamper-evident, and tear-resistant bags containing household medications at the law enforcement agency in a securely locked storage area in a manner consistent with that agency’s standard procedures for storing illicit controlled substances.

23.15.4 Physical Security Controls for Transporters

A. Sealed inner liners and opaque, waterproof, tamper-evident, and tear-resistant bags containing household medications acquired by transporters shall be securely stored in accordance with U.S.

Department of Justice, Drug Enforcement Administration, 21 CFR § 1301.72(a), Physical security controls for non-practitioners; (a) Schedules I and II, revised as of April 1, 2019, and hereby incorporated by reference.

23.16 Registrant Household Medication Records and Inventories

23.16.1 General Household Medication Recordkeeping Requirements for Registrants

A. Every registrant required to keep records pursuant to U.S. Department of Justice, Drug Enforcement Administration, 21 CFR § 1304, Records and Reports of Registrants, revised as of April 1, 2019, and hereby incorporated by reference, shall maintain, on a current basis, a complete and accurate record of each inner liner and sealed inner liner, except that no registrant shall be required to maintain a perpetual inventory.

B. Registrants shall maintain separate records for each independent activity and collection activity for which they are registered or authorized.

C. In recording dates of receipt, transfer, or destruction, the date on which the household medications are actually received, transferred, or destroyed shall be used as the date of receipt, transfer, or destruction (e.g., invoices, packing slips, manifests or DEA Form 41).

D. In addition to any other recordkeeping requirements, any DEA-registrant that destroys a sealed inner liner or sealed bag containing household medications, or causes the destruction of sealed inner liner or sealed bag containing household medications, shall maintain a record of destruction on a DEA Form 41. The records shall be complete and accurate, and include the name and signature of the two employees who witnessed the destruction.

E. Registrants shall maintain the records required in Section 23.16.2 and inventories required in Section 23.16.3 in an easily retrievable format, on-site for three (3) years from the date the waste was acquired by a transporter.

23.16.2 Required Registrant Household Medication Records

A. Transporters shall maintain the following records:

1. For sealed inner liners acquired from collectors by transporters pursuant to Section 23.12.3:

a. The number of sealed inner liners acquired to inventory, including the dates of acquisition; the size (e.g., five 10-gallon liners, etc.) of all sealed inner liners acquired; the weight of each sealed inner liner acquired; the unique identification number of each sealed inner liner acquired; and the name, address, and, for DEA-registrant collectors, the registration number of the collector from whom the sealed inner liners were acquired; and

b. The number of sealed inner liners destroyed; the date, place, and method of destruction; the size (e.g., five 10-gallon liners, etc.) of all sealed inner liners destroyed; the unique identification number of each sealed inner liner destroyed;

the name, address, and, for DEA-registrant collectors, the registration number of the collector from whom the sealed inner liners were acquired; and the name and signatures of the two employees of the transporter that witnessed the destruction.

2. For opaque, waterproof, tamper-evident, and tear-resistant bags containing household medications acquired from law enforcement agency collectors by transporters pursuant to Section 23.12.3:

a. The number of bags acquired to inventory, including the dates of acquisition; the size (e.g., five 10-gallon liners, etc.) of all bags acquired; the weight of each bag acquired; the unique identification number of each bag acquired; and the name and address of the law enforcement agency collector from whom the bags were acquired; and

b. The number of bags destroyed; the date, place, and method of destruction; the size (e.g., five 10-gallon liners, etc.) of all bags destroyed; the unique identification number of each bag destroyed; the name and address of the law enforcement agency collector from whom the bags were acquired; and the name and signatures of the two employees of the transporter that witnessed the destruction.

3. For all records, the record of acquisition shall be maintained together with the corresponding record of destruction on a DEA Form 41.

B. DEA-registered household medication collectors shall maintain the following records:

1. Collection receptacle inner liners:

a. Date each unused inner liner is acquired and its unique identification number and size (e.g., 5-gallon, 10-gallon, etc.);

b. Date each inner liner is installed, the address of the location where each inner liner is installed, the unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each installed inner liner, the registration number of the collector, and the names and signatures of the two employees that performed each installation as described in Section 23.9(C)(1);

c. Date each inner liner is removed and sealed, the address of the location from which each inner liner is removed, the unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each inner liner removed, the registration number of the collector, and the names and signatures of the two employees that performed each removal as described in Section 23.9(C)(1);

d. Date each sealed inner liner is transferred to storage, the unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each sealed inner liner stored, and the names and signatures of the two employees that transferred each sealed inner liner to storage as described in Section 23.11.1(A)(2); and

e. Date each sealed inner liner is transferred for destruction, the address and registration number of the transporter to whom each sealed inner liner was transferred, the unique identification number and the size (e.g., 5-gallon, 10-gallon, etc.) of each sealed inner liner transferred, and the names and signatures of the two employees that transferred each sealed inner liner to the transporter as described in Section 23.11.1(A)(1).

23.16.3 Required Registrant Controlled Substance Inventories

A. Transporters participating in the program and required to keep inventories of controlled substances pursuant to U.S. Department of Justice, Drug Enforcement Administration, 21 CFR § 1304, Records and Reports of Registrants; revised as of April 1, 2019, and hereby incorporated by reference, shall include the following information in their inventories:

1. For household medications, including controlled substances collected from ultimate users, acquired from DEA-registered collectors and law enforcement agency collectors:

The number and size (e.g., five 10-gallon liners, etc.) of sealed inner liners on hand.

B. DEA-registered collectors participating in the program and required to keep inventories of controlled substances pursuant to U.S. Department of Justice, Drug Enforcement Administration, 21 CFR § 1304, Records and Reports of Registrants; revised as of April 1, 2019, and hereby incorporated by reference, shall include the following information in their inventories:

1. The date of the inventory;

2. The number and size of sealed inner liners in storage (e.g., five 10-gallon liners, etc.);

and

3. The unique identification number of each inner liner.

23.17 Law Enforcement Agency Collector Household Medication Records

23.17.1 General Household Medication Recordkeeping Requirements for Law Enforcement Agency Collectors

A. Law enforcement agency collectors shall maintain the records required in Section 23.17.2 in an easily retrievable format, on-site for three (3) years from the date the waste was acquired by a transporter.

23.17.2 Required Law Enforcement Agency Collector Household Medication Records

A. Law enforcement agency collectors shall maintain the following records:

1. Collection receptacle inner liners:

a. Date each unused inner liner is obtained and its unique identification number and size (e.g., 5-gallon, 10-gallon, etc.);

b. Date each inner liner is installed, the address of the location where each inner liner is installed, the unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each installed inner liner, and the names and signatures of the employees described in Section 23.9(C)(2) or the law enforcement officer described in Section 23.10(B) that performed each installation;

c. Date each inner liner is removed and sealed, the address of the location from which each inner liner is removed, the unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each inner liner removed, and the names and signatures of the employees described in Section 23.9(C)(2) or the law enforcement officer described in Section 23.10(B) that performed each removal;

d. Date each sealed inner liner is transferred to storage, the unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each sealed inner liner stored, and the names and signatures of the employees that transferred each sealed inner liner to storage as described in Section 23.11.2(A)(2); and

e. Date each sealed inner liner is transferred for destruction, the address and registration number of the transporter to whom each sealed inner liner was transferred, the unique identification number and the size (e.g., 5-gallon, 10-gallon, etc.) of each sealed inner liner transferred, and the names and signatures of the employees that transferred each sealed inner liner to the transporter as described in Section 23.11.2(A)(1) or Section 23.11.2(B)(1).

2. Opaque, waterproof, tamper-evident, and tear-resistant bags with household medications collected at take-back events through means other than a collection receptacle:

a. Date each bag is sealed, the address of the location at which each bag is sealed, the unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each bag sealed, and the name and signature of the law enforcement officer described in Section 23.10(B) that sealed each bag;

b. Date each sealed bag is transferred to storage, the unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each sealed bag stored, and the name and signature of the law enforcement officer described in Section 23.10(B) that transferred each bag to storage; and

c. Date each sealed bag is transferred for destruction, the address and registration number of the transporter to whom each sealed bag was transferred, the unique identification number and the size (e.g., 5-gallon, 10-gallon, etc.) of each sealed bag transferred, and the names and signatures of the employees or law enforcement officer that transferred each sealed bag to the transporter as described in Section 23.11.2(A)(1) or Section 23.11.2(B)(1)(a).

3. If approved by the department, a law enforcement agency may utilize a method of inner liner documentation other than those described in Section 23.17.2(A)(1) and Section 23.17.2(A)(2). The alternative method must be consistent with the agency’s recordkeeping requirements for illicit controlled substances evidence.

23.18 Household Medication Collectors Ceasing Collection Activities

A. DEA-registered collectors ceasing participation in the program and ceasing collection of household medications shall:

1. Notify the department;

2. Dispose of household medications on hand in accordance with Section 23.11.1; and

3. Notify the DEA of their intent to cease collection of controlled substances from ultimate users in accordance with U.S. Department of Justice, Drug Enforcement Administration, 21 CFR § 1301.52(f), Termination of registration; revised as of April 1, 2019, and hereby incorporated by reference.

B. Law enforcement agency collectors ceasing participation in the program and ceasing collection of household medications, including controlled substances collected from ultimate users shall:

1. Notify the department; and

2. Dispose of household medication on hand in accordance with Section 23.11.2.

Part II. Household Sharps

23.19 Specific Standards for Department-Approved Household Sharps Collectors, Transporters, and Disposal Locations

23.19.1 Household Sharps Collectors

A. Application to Become a Department-Approved Collector: In order to collect household sharps as a department-approved participant in the program, a collector shall:

1. Submit a department-approved application form.

2 Designate an individual responsible for oversight of household sharps collection activities.

3. Install a department-provided collection receptacle at the collector’s physical location in an area regularly monitored by employees.

4. Provide training to employees in accordance with U.S. Department of Labor, Occupational Safety and Health Administration’s (OSHA) Bloodborne Pathogens standard, 29 CFR § 1910.1030(g)(2), effective June 4, 1992, hereby incorporated by reference.

5. Develop, implement, and maintain on site, in an easily retrievable format, a Medical Waste Management Plan containing, at a minimum, the following elements:

a. Procedures for household sharps identification, collection, packaging, storage, transport and disposal designed to prevent adverse events to the public and collector, transporter, treatment facility and disposal location employees;

b. A contingency plan for spills and releases;

c. Employee training procedures;

d. Designation of an individual or individuals responsible for implementing the plan;

and

e. Recordkeeping methods.

B. Collector Recordkeeping Responsibilities

1. Household sharps collectors shall maintain a record of employee training provided in accordance with Section 23.19.1(A)(4) in an easily retrievable format, on-site, for three years from the date of training.

2. Household sharps collectors shall maintain copies of transporter-provided waste manifests, tracking documents, or chain of custody forms in an easily retrievable format, on-site for three years from the date of receipt.

C. Household Sharps Collectors Ceasing Collection Activities

1. Household sharps collectors ceasing participation in the program and ceasing collection of household sharps shall:

a. Notify the department; and

b. Transfer household sharps on hand to a department-approved transporter in accordance with Section 23.19.2(B)(1).

23.19.2 Household Sharps Transporters

A. Application to Become a Department-Approved Transporter: In order to acquire household sharps from collectors or from individuals as a department-approved participant in the program, a transporter shall:

1. Execute a contract or other written, signed service agreement with the department;

2. Provide training to its employees in accordance with Regulations Pertaining to Solid Waste Sites and Facilities, 6 CCR 1007-2, Part 1, Part B, Section 13.7.2(C)(9), that includes, but is not limited to: medical waste identification, bloodborne pathogens, waste containment and labeling; storage requirements; equipment operations including equipment startup, shutdown, maintenance, and associated procedures to assure safe operation; and roles and responsibilities when implementing a facility contingency plan;

3. Utilize a department-approved treatment facility that renders acquired household sharps non-infectious in accordance with Section 23.19.2(C); and

4. Dispose of treated household sharps in accordance with Section 23.19.2(D).

B. Transporter Procedures for the Acquisition of Household Sharps

1. Transporters that acquire household sharps from department-approved collectors are authorized to utilize only the following methods: on-site pick-up or delivery by common carrier or contract carrier.

2. Transporters that acquire household sharps from individuals are authorized to…