(DEA, EPA) as well as state-specific rules governed by the California Department of Public Health (CDPH) and the California Department of Toxic Substances Control (DTSC).
The requirements differ depending on whether the generator is a healthcare facility or an individual (patient) at home.
🔹 Healthcare Facilities in California
Healthcare facilities in California—such as hospitals, clinics, pharmacies, long-term care, and veterinary clinics—must comply with multiple overlapping requirements for pharmaceutical waste disposal. Here's a breakdown:
1. Hazardous Waste Pharmaceuticals (RCRA and California-RCRA)
Federal RCRA hazardous waste pharmaceuticals must be managed under the EPA Subpart P (40 CFR 266).
California-designated hazardous wastes (called “non-RCRA hazardous waste”) are also regulated under Title 22 of the California Code of Regulations.
California uses a broader list of hazardous pharmaceuticals compared to federal standards.
🛠️ Action: Use a waste profile to determine if a pharmaceutical is federally hazardous, California-only hazardous, or non-hazardous.
2. Subpart P – EPA Regulations for Healthcare Facilities
Must comply with Subpart P for managing hazardous waste pharmaceuticals (if a Large Quantity Generator or Reverse Distributor).
Sewering (flushing) of hazardous waste pharmaceuticals is prohibited under both federal and state rules.
Maintain a pharmaceutical waste management plan and employee training.
3. Non-Hazardous Pharmaceutical Waste
Includes over-the-counter (OTC), non-RCRA hazardous, and expired non-controlled meds.
Must be managed as medical waste per California’s Medical Waste Management Act.
Disposal through medical waste haulers or approved mail-back programs.
4. Controlled Substances (DEA Schedule II–V)
Must be destroyed per DEA requirements (21 CFR 1317).
Destruction must render substances non-retrievable.
Destruction must be witnessed and documented.
🛠️ Action: Partner with a DEA-registered reverse distributor or use on-site destruction technology that meets DEA’s non-retrievable standard.
5. Labeling, Storage, and Transportation
Clearly label containers as "Pharmaceutical Waste – Incineration Only" (for hazardous/non-hazardous Rx).
Store separately from regulated medical waste and sharps.
Use licensed hazardous or medical waste transporters.
✅ PureWay Solutions for Healthcare Facilities in California
PureWay provides:
Pharmaceutical waste mail-back systems (DEA-compliant, CA-licensed)
Hazardous waste profiling and disposal (including CA-only hazardous)
Reverse distribution support
On-site staff training for Subpart P, DEA compliance, and CA rules
Access to PureWay's state-by-state compliance guide: 👉 PureWay California Compliance Guide
🔹 Patients (At-Home Pharmaceutical Waste Disposal)
Patients at home face a different set of rules. While they are not considered "generators" under hazardous waste laws, they must still follow safe disposal practices:
1. Prescription Medications (Non-Controlled)
Preferred: Use authorized drug take-back programs or DEA-registered collection receptacles.
Alternative: Use a pharmaceutical mail-back envelope (offered by some pharmacies or PureWay partners).
Last resort: Dispose in household trash only after:
Mixing meds with an unpalatable substance (e.g., used coffee grounds)
Sealing in a plastic bag
Marking “DO NOT RECYCLE”
2. Controlled Substances (Schedule II–V)
Must go to a DEA-authorized collection site (e.g., pharmacy or police station).
Cannot be mailed back unless using a DEA-compliant mail-back envelope.
3. Sharps with Residual Pharmaceuticals (e.g., insulin pens)
Must be disposed of in approved sharps containers.
Sharps must not go into household trash in California.
Disposal options:
Mail-back sharps containers (PureWay offers CA-compliant kits)
Local drop-off sites (check city/county programs)
✅ PureWay Solutions for Patients at Home
Mail-back pharmaceutical disposal envelopes (DEA-compliant)
Sharps mail-back containers
Resources for locating take-back options or ordering mail-back kits online
⚠️ Penalties for Noncompliance
Pharmaceutical waste disposal procedure violations can result in:
Fines from DTSC or CDPH
DEA enforcement actions for improper controlled substance disposal
OSHA citations for unsafe workplace practices (in healthcare settings)