Regulated Waste Disposal for 503A and 503B Compounding Pharmacies

Why Proper Waste Disposal Is Critical for Compounders

Whether you're preparing patient-specific compounds or sterile injectables in bulk, your facility is responsible for the safe and compliant handling of:

• Expired raw materials and finished products

• Schedule II–V controlled substances (e.g., compounded opioids, benzodiazepines)

• Hazardous pharmaceuticals (e.g., estradiol, warfarin, fluorouracil, cyclophosphamide)

• Contaminated PPE, filters, gowns, and sharps from sterile rooms

• Wastewater or solvent residues from cleanroom operations

Failure to follow federal and state regulations can result in:

• DEA and EPA violations

• State Board of Pharmacy citations

• USP <800> and <797> noncompliance

• OSHA BBP penalties

• Civil liability for environmental or public health impact

Easy RX Cycle offers complete, compliant services backed by documentation for inspections, audits, and licensure.

What We Help Compounding Pharmacies Dispose Of

DEA-Controlled Substances (Schedule I–V)

• Expired compounded narcotics and sedatives

• Partial vials, contaminated or spilled formulations

• DEA Form 41 destruction support

• DEA Form 222 for reverse distribution (Schedule I–II)

Non-Controlled Pharmaceuticals

• Expired creams, suspensions, troches, and injectables

• Unit-dose and bulk compounded medications

• Returned or discontinued compounds

Hazardous Pharmaceutical Waste (RCRA)

• P-listed drugs (warfarin, nicotine)

• U-listed drugs (chloral hydrate, cyclophosphamide)

• Chemotherapy agents and trace hazardous residues

• Contaminated wipes, pads, PPE, and sharps

Regulated Medical Waste (RMW)

• Sharps used in sterile compounding

• Bloodborne pathogen-contaminated waste

• Gloves, gowns, and hoods from cleanroom environments

Waste Disposal Options Tailored for Compounding Pharmacies

Mail-Back Kits

• DEA- and DOT-compliant kits (1–5 gallons)

• Accepts expired compounds, controlled substances, and sharps

• Ideal for community pharmacies and low-to-moderate waste generators

• Prepaid shipping, full tracking, DEA Form 41 support

• Certificate of Destruction included

Scheduled On-Site Pickup

• Suited for 503B outsourcing facilities and high-volume compounders

• Licensed transport of RMW, pharmaceutical, and hazardous waste

• DEA Form 41/222 assistance and witnessed destruction support

• Chain-of-custody documentation and regulatory reporting

• Flexible pickup frequency based on production volume

Who We Serve

Our services are designed for:

• 503A traditional compounding pharmacies

• 503B FDA-registered outsourcing facilities

• Sterile and non-sterile compounders

• Hospital and health system compounding labs

• Veterinary compounders

• Mobile and mail-order compounders

• Clinics and infusion centers with in-house compounding

Whether you're managing individualized patient formulations or large-scale sterile production, Easy RX Cycle offers scalable solutions tailored to your compliance requirements.

Full Compliance with DEA, RCRA, EPA, OSHA, and State Pharmacy Boards

Easy RX Cycle ensures complete alignment with:

• DEA 21 CFR Part 1317 – Non-recoverable controlled substance destruction

• DEA Form 41 & Form 222 – Witnessed destruction and secure transfer

• EPA RCRA Subtitle C – Hazardous pharmaceutical waste

• USP <800> & <797> – Hazardous drug handling and compounding standards

• OSHA 29 CFR 1910.1030 – Sharps and bloodborne pathogen compliance

• DOT 49 CFR Part 173 – Medical and pharmaceutical waste transport

• State Board of Pharmacy & Department of Health requirements

We provide Certificates of Destruction, manifest tracking, and compliance logs suitable for FDA, state, and Board of Pharmacy inspections

Request a Quote Today!