1. A. This regulation establishes requirements for a facility identified in Regulation .37A of this chapter to notify the Department that the facility:

   1. (1) Is operating under the standards of this chapter relating to the management of hazardous waste pharmaceuticals; and
   2. (2) Will no longer be operating under the standards of this chapter relating to the management of hazardous waste pharmaceuticals.

2. B. Notification of Operation.

   1. (1) A healthcare facility shall notify the Department that the healthcare facility is operating under the standards of this chapter relating to the management of hazardous waste pharmaceuticals by:

      1. (a) Submitting an initial or revised Site Identification Form (EPA Form 8700-12) to the Department; and
      2. (b) Completing the questions on “Pharmaceutical Activities” in the “Additional Regulated Waste Activities” section of the Site Identification Form, checking the “yes” box on the form to indicate that the facility is operating under 40 CFR Part 266, Subpart P for the management of hazardous waste pharmaceuticals.
   2. (2) A healthcare facility submitting a notification under this section is not required to list waste codes for the facility’s hazardous waste pharmaceuticals in Box 10B of the Site Identification Form, but shall list waste codes in Box 10B for non-pharmaceutical hazardous wastes that are generated or managed at the facility.
   3. (3) A person that is the owner or operator of multiple sites or locations that are operating under the standards of this chapter relating to the management of hazardous waste pharmaceuticals shall submit a separate notification for each site or existing EPA identification number, except that a single notification is required for a location with multiple sites that are considered to be on the site of a single facility.

   4. (4) Deadlines for the Notification Required by §B(1) of this Regulation.

      1. (a) A healthcare facility that already has an EPA identification number shall make the notification:

         1. (i) As part of the healthcare facility’s next biennial report of hazardous waste activity, if the healthcare facility’s generator status under federal regulations is “large quantity generator”, or if federal regulations otherwise require the healthcare facility to submit a biennial report of hazardous waste activity; or
         2. (ii) If the healthcare facility does not meet the criteria of §B(4)(a)(i) of this regulation, within 60 days after the effective date of §B of this regulation, or within 60 days after the date the healthcare facility becomes subject to the standards of this chapter relating to the management of hazardous waste pharmaceuticals, whichever is later.
      2. (b) A healthcare facility that does not have an EPA identification number shall make the notification within 60 days after the effective date of §B of this regulation, or within 60 days after the date the healthcare facility becomes subject to the standards of this chapter relating to the management of hazardous waste pharmaceuticals, whichever is later.
   5. (5) A healthcare facility shall keep a copy of its notification on file for as long as the healthcare facility is operating under the standards of this chapter relating to the management of hazardous waste pharmaceuticals.

3. C. Notification of Withdrawal.

   1. (1) Applicability. This section applies to a healthcare facility that:

      1. (a) Either:

         1. (i) Had been required to manage hazardous waste pharmaceuticals in accordance with the regulations identified in Regulation .32E(3) of this chapter, but is no longer required to do so because the facility is now classified as a very small quantity generator under federal regulations, as described in COMAR 26.13.03.01-1B, when counting all of the hazardous waste it generates in a calendar month, including both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste; and
         2. (ii) Will not be voluntarily complying with the requirements of Regulation .32E(3) of this chapter for the management of the facility’s hazardous waste pharmaceuticals, as an alternative to managing the hazardous waste pharmaceuticals in accordance with COMAR 26.13.02.05 and the optional provisions of Regulation .36 of this chapter; or
      2. (b) Had voluntarily elected to comply with the requirements of Regulation .32E(3) of this chapter for the management of the facility’s hazardous waste pharmaceuticals, but no longer will be doing so, and will instead be managing the hazardous waste pharmaceuticals in accordance with COMAR 26.13.02.05 and the optional provisions of Regulation .36 of this chapter.

   2. (2) A healthcare facility identified in §C(1) of this regulation shall:

      1. (a) Before beginning to manage hazardous waste pharmaceuticals in accordance with COMAR 26.13.02.05, notify the Department that the healthcare facility will no longer be operating under the standards of this chapter relating to the management of hazardous waste pharmaceuticals;

      2. (b) Make the notification required by §C(2)a) of this regulation by:

         1. (i) Submitting a Site Identification Form (EPA Form 8700-12) to the Department; and
         2. (ii) Completing the questions on “Pharmaceutical Activities” in the “Additional Regulated Waste Activities” section of the Site Identification Form, as directed in the instructions for the form; and
      3. (c) Keep a copy of its withdrawal notification on file for at least 3 years from the date of signature on the notification of withdrawal.
   3. (3) A healthcare facility submitting a notification under this section is not required to list waste codes for the facility’s hazardous waste pharmaceuticals in Box 10B of the Site Identification Form.
   4. (4) A person that is the owner or operator of multiple sites or locations that are required to submit notification under this section shall submit a separate notification of withdrawal for each affected site or existing EPA identification number, except that a single notification is required for a location with multiple sites that are considered to be on the site of a single facility.

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)