1. A. Hazardous Waste Determination for Potentially Creditable Pharmaceuticals.

   1. (1) A healthcare facility that generates a solid waste that is a potentially creditable pharmaceutical shall determine whether that pharmaceutical is a hazardous waste pharmaceutical by determining whether the waste is listed as a hazardous waste in COMAR 26.13.02.15—.19, and whether the waste exhibits any of the characteristics of hazardous waste defined in COMAR 26.13.02.10—.14.
   2. (2) In determining whether a solid waste is a hazardous waste, a healthcare facility shall follow the procedures in COMAR 26.13.03.02-1.
   3. (3) A healthcare facility shall use the hazardous waste determination conducted in accordance with this section to determine the applicability of Regulations .32—.49 of this chapter to the waste, except that the healthcare facility may choose to manage its potentially creditable non-hazardous waste pharmaceuticals as potentially creditable hazardous waste pharmaceuticals under Regulations .32—.49 of this chapter.

2. B. Acceptance of Potentially Creditable Hazardous Waste Pharmaceuticals from Off Site.

   1. (1) This section establishes conditions under which a healthcare facility may accept potentially creditable hazardous waste pharmaceuticals from an off-site healthcare facility that qualifies, under federal regulations, as a very small quantity generator (VSQG) of hazardous waste.
   2. (2) Regulation .32F of this chapter specifies criteria that determine whether a generator of hazardous waste pharmaceuticals qualifies as a very small quantity generator of hazardous waste under federal regulations.

   3. (3) . For the purposes of this regulation:

      1. (a) “Person” has the meaning given by the definition in COMAR 26.13.01.03B; and

      2. (b) “Control”:

         1. (i) Means the power to direct the policies of the healthcare facility, whether by the ownership of stock, voting rights, or otherwise; and
         2. (ii) Does not include the situation when a contractor operates healthcare facilities on behalf of a different person.

   4. (4) A healthcare facility that does not have a permit or interim status that allows the facility to accept hazardous waste from off site may accept potentially creditable hazardous waste pharmaceuticals from an off-site healthcare facility if:

      1. (a) The off-site facility qualifies, under federal regulations, as a very small quantity generator (VSQG) of hazardous waste;

      2. (b) Either:

         1. (i) The receiving facility and the VSQG healthcare facility that is sending the potentially creditable hazardous waste pharmaceuticals off site are under the control of the same person, as specified in §B(3) of this regulation; or
         2. (ii) The receiving facility has a contractual or other documented business relationship whereby the receiving healthcare facility supplies pharmaceuticals to the VSQG healthcare facility; and

      3. (c) The receiving facility:

         1. (i) Is operating under the provisions of Regulations .32—.49 of this chapter for the management of the receiving facility’s potentially creditable hazardous waste pharmaceuticals;
         2. (ii) Manages the potentially creditable hazardous waste pharmaceuticals that it receives from off site in compliance with the requirements of Regulations .32—.49 of this chapter; and
         3. (iii) Keeps records of the potentially creditable hazardous waste pharmaceuticals that the facility receives from off site for 3 years from the date that the shipment is received, except that the periods of retention of these records is extended automatically during the course of any unresolved enforcement action regarding the regulated activity;
3. C. Prohibition of Shipment. Except for potentially creditable hazardous waste pharmaceuticals, a healthcare facility may not send hazardous waste to a reverse distributor.
4. D. Biennial Reporting. A healthcare facility is not subject to biennial reporting requirements under COMAR 26.13.03.06B with respect to potentially creditable hazardous waste pharmaceuticals managed under Regulations .32—.49 of this chapter.

5. E. Record Keeping. A healthcare facility that initiates a shipment of a potentially creditable hazardous waste pharmaceutical to a reverse distributor shall:

   1. (1) Keep the following records, in either a paper or electronic format, for each shipment of a potentially creditable hazardous waste pharmaceutical:

      1. (a) The confirmation of delivery; and
      2. (b) The shipping paper or papers prepared in accordance with 49 CFR Part 172 Subpart C, if applicable;
   2. (2) Unless the period of retention is extended in accordance with §E(3) of this regulation, retain the records identified in §E(1) of this regulation for at least 3 years from the date of shipment;

   3. (3) Maintain a record beyond the period specified in §E(2) of this regulation:

      1. (a) During the course of any unresolved enforcement action regarding the regulated activity; or
      2. (b) As requested by the Department or the Regional Administrator of Region 3 of the EPA; and
   4. (4) Ensure that any record required to be kept by this regulation is made readily available upon the request of an inspector representing the Department or the EPA.

6. F. Response to Spills. A healthcare facility shall:

   1. (1) Immediately contain a spill of a potentially creditable hazardous waste pharmaceutical; and
   2. (2) Manage clean-up materials from a spill of a potentially creditable hazardous waste pharmaceutical as non-creditable hazardous waste pharmaceuticals in accordance with Regulations .32—.48 of this chapter.

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)