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Reverse Distributors and Reverse Logistics

A Reverse Distributor (RD), as defined in 40 CFR § 266.510, 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 on the Definitions web page and 40 CFR § 266.500.

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

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Virginia Department of
Environmental Quality
P.O. Box 1105
Richmond, VA 23218
(804) 698-4000


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