Maryland’s Hazardous Waste Pharmaceutical Rule Now in Effect
Understanding COMAR 26.13.10.32–.49 (Subpart P Adoption)
As of October 1, 2025, the Maryland Department of the Environment (MDE) officially adopted the EPA’s Subpart P (40 CFR 266) standards for hazardous waste pharmaceuticals. These new Maryland regulations represent one of the most significant revisions to pharmaceutical waste management in years, modernizing how healthcare facilities, pharmacies, and reverse distributors handle discarded or expired pharmaceuticals. The updated rules are designed to bring Maryland’s framework in line with federal standards while also offering important compliance relief for generators and healthcare organizations.
What Changed
Maryland’s updated hazardous waste regulations — codified in COMAR 26.13.10.32 – .49 — establish healthcare-specific standards that replace the older hazardous-waste framework. These 2025 regulatory revisions affect nearly every stage of pharmaceutical waste management, from storage and labeling to transportation and disposal.
Key provisions include:
- No sewering of hazardous waste pharmaceuticals.
- Up to 365 days of accumulation time for non-creditable waste.
- Clear “empty container” definitions for IV bags, syringes, and unit-dose packaging.
- Optional simplified rules for Very Small Quantity Generators (VSQGs) and long-term-care facilities.
- Consolidation allowed for multi-site healthcare systems under common ownership.
These new Maryland regulatory changes under COMAR 26.13 give healthcare providers a more consistent and environmentally responsible way to manage hazardous pharmaceutical waste, ensuring proper disposal while reducing regulatory burden.
Compliance Relief
Under Subpart P, hazardous waste pharmaceuticals no longer count toward a facility’s hazardous-waste generator status. This regulatory change means Maryland hospitals, pharmacies, clinics, and veterinary providers can manage these wastes under the new standards without affecting their generator classification or biennial reporting thresholds — reducing both risk and administrative burden.
Who’s Covered
The term “healthcare facility” under Maryland’s hazardous waste pharmaceutical regulations extends far beyond hospitals. It includes pharmacies, long-term-care facilities, clinics, veterinary offices, dental providers, optical practices, wholesalers, and ambulance services — virtually any entity authorized to distribute, dispense, or use pharmaceuticals.
This broad coverage ensures that Maryland’s healthcare and pharmaceutical sectors are held to consistent COMAR 26.13 standards, strengthening environmental protection while simplifying compliance across the entire state.
Required Actions
- File or update EPA Form 8700-12 to notify MDE that your facility operates under Subpart P.
- Update your labeling, storage, and training programs to reflect the new requirements.
- Review how empty containers, controlled substances, and reverse-distribution shipments are managed.
- Retain required records and manifests for at least 3 years.
Need Help Navigating the New Rule?
Advant-Edge Solutions of Middle Atlantic, Inc. (ASMAI) specializes in compliant, sustainable pharmaceutical and medical-waste programs. We help healthcare organizations across Maryland and the Mid-Atlantic region:
- Conduct compliance audits and staff training
- Design container and consolidation systems
- Manage pharmaceutical, medical, and hazardous waste under state and federal standards.
See more about our pharmaceutical waste disposal services.
Subpart P is now in effect in Maryland.
If your facility hasn’t completed its compliance review or notification filing, it’s not too late to get on track. Our team can help you understand and implement the latest COMAR 26.13 revisions and Subpart P of 40 CFR Part 266, so you can remain compliant.
Contact ASMAI today for guidance, documentation assistance, or a customized pharmaceutical waste compliance quote. We’re here to help Maryland’s healthcare community navigate these important new pharmaceutical regulations with confidence.