1. A. A healthcare facility or a reverse distributor that transports off site or offers for transport off site potentially creditable hazardous waste pharmaceuticals to a reverse distributor shall comply with all applicable U.S. Department of Transportation regulations in 49 CFR Parts 171—180 for any potentially creditable hazardous waste pharmaceutical that meets the definition of hazardous material in 49 CFR § 171.8. Agency Note: For the purposes of the U.S. Department of Transportation’s regulations, a material is considered a hazardous waste if it is subject to the hazardous waste manifest requirements of the U.S. Environmental Protection Agency specified in 40 CFR Part 262. Because a potentially creditable hazardous waste pharmaceutical does not require a hazardous waste manifest, it is not considered a hazardous waste under the U.S. Department of Transportation’s regulations.

2. B. Delivery Confirmation. A reverse distributor that receives a shipment of potentially creditable hazardous waste pharmaceuticals:

   1. (1) Shall, upon receipt of the shipment, provide confirmation of receipt to the healthcare facility or reverse distributor that initiated the shipment;
   2. (2) Shall indicate in the confirmation of receipt that the shipment of potentially creditable hazardous waste pharmaceuticals has arrived at its destination and is under the control of the reverse distributor; and
   3. (3) May provide the confirmation of receipt in a paper format or an electronic format.

3. C. Required Actions if a Timely Confirmation of Delivery is not Received. If 35 days have elapsed since a healthcare facility or reverse distributor initiated a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor, and the initiating shipper has not received confirmation of delivery, the initiating shipper shall promptly contact the carrier and the reverse distributor that was the intended recipient of the shipment to:

   1. (1) Report that the delivery confirmation has not been received; and
   2. (2) Determine the status of the potentially creditable hazardous waste pharmaceuticals that were shipped.

4. D. Exports. A healthcare facility or reverse distributor that sends a potentially creditable hazardous waste pharmaceutical to a foreign destination:

   1. (1) Is not required to comply with the manifesting requirements of 40 CFR § 262.83(c);

   2. (2) Shall comply with:

      1. (a) The applicable sections of 40 CFR Part 262, Subpart H, as qualified by COMAR 26.13.03.07B(2); and
      2. (b) §§A—C of this regulation.

5. E. Imports.

   1. (1) A person that imports potentially creditable hazardous waste pharmaceuticals into the United States is subject to §§A—C of this regulation instead of 40 CFR Part 262, Subpart H.
   2. (2) Immediately after a potentially creditable hazardous waste pharmaceutical enters the United States, the potentially creditable hazardous waste pharmaceutical is subject to all applicable requirements of Regulations .32—.49 of this chapter.

6. F. Transporter Requirements. A person that transports potentially creditable hazardous waste pharmaceuticals to a reverse distributor:

   1. (1) May do so without meeting the requirements of COMAR 26.13.04 that apply to persons who transport hazardous waste; and
   2. (2) Shall comply with all applicable requirements of the U.S. Department of Transportation for the transport of hazardous materials.

Authority: Environment Article, §6-905.3 and Title 7, Subtitle 2, Annotated Code of Maryland

Effective date: April 18, 1988 (15:8 Md. R. 1009)

Chapter recodified from COMAR 10.51.11 to 26.13.10

Regulation .01A, C amended effective May 24, 1993 (20:10 Md. R. 853)

Regulation .01A, D amended effective May 1, 2008 (35:8 Md. R. 809); October 1, 2025 (52:17 Md. R. 876)

Regulation .01C, D amended effective October 16, 2000 (27:20 Md. R. 1843)

Regulation .02A amended effective December 23, 1991 (18:25 Md. R. 2759); October 16, 2000 (27:20 Md. R. 1843); November 1, 2002 (29:21 Md. R. 1647)

Regulation .02E, F amended effective May 3, 2021 (48:9 Md. R. 359)

Regulation .03A, B amended effective November 1, 2002 (29:21 Md. R. 1647)

Regulation .03B, D amended effective October 16, 2000 (27:20 Md. R. 1843); January 13, 2022 (49:1 Md. R. 14)

Regulation .04 amended effective November 1, 2002 (29:21 Md. R. 1647); January 13, 2022 (49:1 Md. R. 14)

Regulation .04B, C amended effective October 16, 2000 (27:20 Md. R. 1843)

Regulation .04J amended effective October 1, 2025 (52:17 Md. R. 876)

Regulation .05 adopted effective September 7, 1998 (25:18 Md. R. 1438)

Regulations .06—.25 adopted effective November 1, 2002 (29:21 Md. R. 1647)

Regulation .06B amended effective May 1, 2008 (35:8 Md. R. 809); October 1, 2025 (52:17 Md. R. 876)

Regulation .08A, B amended effective October 1, 2025 (52:17 Md. R. 876)

Regulation .09 amended effective May 1, 2008 (35:8 Md. R. 809)

Regulation .09-1 adopted effective October 1, 2025 (52:17 Md. R. 876)

Regulation .10A amended effective May 3, 2021 (48:9 Md. R. 359)

Regulation .11C amended effective January 18, 2016 (43:1 Md. R. 14)

Regulation .14 amended effective May 1, 2008 (35:8 Md. R. 809)

Regulation .14B amended effective May 3, 2021 (48:9 Md. R. 359); October 1, 2025 (52:17 Md. R. 876)

Regulation .16-1 adopted effective October 1, 2025 (52:17 Md. R. 876)

Regulation .17A amended effective May 1, 2008 (35:8 Md. R. 809); October 1, 2025 (52:17 Md. R. 876)

Regulation .18C amended effective January 13, 2022 (49:1 Md. R. 14)

Regulation .19C amended effective May 1, 2008 (35:8 Md. R. 809); October 1, 2025 (52:17 Md. R. 876)

Regulation .20C amended effective May 1, 2008 (35:8 Md. R. 809)

Regulation .20F adopted effective October 1, 2025 (52:17 Md. R. 876)

Regulation .21F amended effective January 13, 2022 (49:1 Md. R. 14)

Regulation .22G amended effective January 13, 2022 (49:1 Md. R. 14)

Regulation .23C amended effective January 13, 2022 (49:1 Md. R. 14)

Regulation .24 amended effective January 13, 2022 (49:1 Md. R. 14)

Regulation .25A amended effective October 1, 2025 (52:17 Md. R. 876)

Regulation .25B amended effective May 3, 2021 (48:9 Md. R. 359)

Regulation .25C adopted effective October 1, 2025 (52:17 Md. R. 876)

Regulation .26 adopted effective January 1, 2007 (33:26 Md. R. 1999)

Regulation .27 adopted effective May 1, 2008 (35:8 Md. R. 809)

Regulation .28 adopted effective May 1, 2008 (35:8 Md. R. 809)

Regulation .29 adopted effective May 1, 2008 (35:8 Md. R. 809)

Regulation .30 adopted effective May 1, 2008 (35:8 Md. R. 809)

Regulation .31 adopted effective May 1, 2008 (35:8 Md. R. 809)

Regulations .32—.49 adopted effective October 1, 2025 (52:17 Md. R. 876)