A Reverse Distributor (RD) is any person that receives and accumulates prescription pharmaceuticals that are potentially creditable Hazardous Waste Pharmaceuticals (HWPs) for the purpose of facilitating or verifying manufacturer credit. RDs can include any persons such as forward distributors, third-party logistics providers, and pharmaceutical manufacturers. They play a critical role in the safe management of HWPs. RDs serve as an intermediary between healthcare facilities (HF) and pharmaceutical manufacturers in determining whether a potentially creditable hazardous waste pharmaceutical (HWP) can receive manufacturer's credit for the HF.

All specific definitions related to the Pharmaceuticals Rule requirements are provided here.

Management Requirements for Reverse Distributors

The three possible management scenarios for Reverse Distributors (RDs) managing Hazardous Waste Pharmaceuticals (HWPs) include:

  • RD receives potentially creditable HWPs, the HWP are evaluated by the RD, and then are sent to a RCRA Treatment, Storage, and Disposal facility (TSDF); or
  • RD manages potentially creditable HWPs received from a HF and sends them to another RD, who may be a manufacturer, for evaluation; or
  • RD manages potentially creditable HWPs received from another RD and sends them to a third RD that must be a manufacturer for evaluation.

Management Requirements for Potentially Creditable and Evaluated HWPs

A summary and comparison of the management requirements for Reverse Distributors managing Potentially Creditable and/or Evaluated Hazardous Waste Pharmaceuticals is displayed in table below. Please use the hyperlinks within the table to navigate to other DEQ web pages or to the specific regulatory provisions for further information regarding the topic.

Table: Potentially Creditable and Evaluated HWPs Management Requirements

MANAGEMENT REQUIREMENTS

REQUIRED FOR BOTH POTENTIALLY CREDITABLE AND EVALUATED HW PHARMACEUTICALS CITATIONS

REQUIRED FOR POTENTIALLY CREDITABLE HW PHARMACEUTICALS

REQUIRED FOR EVALUATED HW PHARMACEUTICALS

Subpart P Notification

40 CFR § 266.510(a)(1)

Yes

Yes

Inventory

40 CFR § 266.510(a)(2)

Yes, Within 30 days of receipt

Yes

Evaluation

40 CFR § 266.510(a)(3) & (a)(4)

Yes, Within 30 days of receipt

NA

Maximum Accumulation Time

40 CFR § 266.510(a)(5)

Yes, 180 days or less

40 CFR § 266.510(b)(1) & (b)(2)

Yes, 180 days or less

Security

40 CFR § 266.510(a)(6)

Yes

Yes

Contingency Plan & Emergency Procedures

40 CFR § 266.510(a)(7)

Yes

Yes

Designate an On-Site Accumulation Area

NA

No

Yes

40 CFR § 266.510(c)(1)

Weekly Inspections

NA

No

Yes

40 CFR § 266.510(c)(2)

Training of Personnel

NA

No

Yes

40 CFR § 266.510(c)(3)

Container Standards

NA

No

Yes

40 CFR § 266.510(c)(4)(ii)-(vi)

Labeling of Containers

NA

No

Yes, With the words "Hazardous Waste Pharmaceuticals"

40 CFR § 266.510(c)(4)(i)

Closure Notification & Performance Standards

40 CFR § 266.510(c)(8)

Yes

Yes

Unauthorized Waste Report

40 CFR § 266.510(a)(9)(i)

Yes

Yes

Additional Reports

40 CFR § 266.510(a)(9)(ii)

Yes

Yes

Recordkeeping

NA

Yes

40 CFR § 266.510(b)(4)

Yes

40 CFR § 266.510(c)(10)

Biennial Reporting

NA

No

Yes

40 CFR § 266.510(c)(9)(i)

Mark Containers with HW Codes Prior to Shipment Off-Site

NA

No

Yes

40 CFR § 266.510(c)(5)

Land Disposal Restrictions

NA

No

Yes

40 CFR § 266.510(c)(9)

Shipping Requirements

Yes

Yes

40 CFR § 266.509

Yes

40 CFR § 266.508

Manifest

NA

No

Yes

40 CFR § 266.508(a)(2)

HW Transporter

NA

No

Yes

Exception Reporting

NA

No

Yes

40 CFR § 266.510(c)(9)(ii)

Procedures for Dealing with Rejected Shipments from TSDFs

NA

NA

Yes

40 CFR § 266.510(c)(7)

Sewer Prohibition

40 CFR §266.505

Yes

Yes