Compliance center
A fully compliant pharmaceutical reverse distributor
Ecopharm is a DEA‑registered pharmaceutical reverse distributor with NABP Drug Distributor Accreditation. Here is every framework that governs our work, and what each one requires of our process.
DEA 21 CFR 1301 & 1317
EPA 40 CFR 266 Subpart PRCRA 40 CFR 261 & 262
DSCSA 21 USC 360eeeFDA GMP 21 CFR 211 & 314
Florida Statute §499 & 61N‑1Licensing
Which regulations govern pharmaceutical reverse distribution?
Four frameworks: DEA registration and recordkeeping, including DEA Form 222 for controlled substances; EPA and RCRA rules for hazardous waste pharmaceuticals; the Drug Supply Chain Security Act (DSCSA); and state licensing.
DEA registration & Form 222
- 21 CFR 1301
- 21 CFR 1305
- 21 CFR 1317
- What it requires
- Any company that reverse distributes controlled substances must hold a DEA registration as a reverse distributor (21 CFR 1317.15). Schedule I and II products move on a DEA Form 222 or its electronic equivalent. The form is valid for 60 days after it is executed and must be kept available for inspection for two years (21 CFR 1305).
- How we meet it
- Ecopharm is registered with the DEA as a reverse distributor. Our software prompts controlled substances as a separate inventory. For Schedule II, we send you a C2 Kit with your DEA Form 222 and a return label; Schedules III to V are bagged separately and labeled with your return number.
EPA & RCRA
- 40 CFR 261
- 40 CFR 262
- 40 CFR 266 Subpart P
- What it requires
- Pharmaceuticals that qualify as hazardous waste must be identified under RCRA (40 CFR 261). EPA's Subpart P sets how healthcare facilities and reverse distributors manage them, with standards specific to reverse distributors (40 CFR 266.510) and a ban on sewering hazardous waste pharmaceuticals (40 CFR 266.505).
- How we meet it
- Our waste teams sort and classify non‑creditable product, identify hazardous waste pharmaceuticals and send each stream to destruction with DEA- and EPA‑approved methods, with records kept for your audits.
DSCSA
- 21 USC 360eee
- What it requires
- The Drug Supply Chain Security Act sets up electronic, interoperable tracing of prescription drugs at the package level. Trading partners, pharmacies included, must exchange transaction information, verify product, investigate suspect product and keep transaction records for at least six years.
- How we meet it
- We help pharmacies understand what DSCSA asks of them and put compliant, audit‑ready tracking workflows in place. See how DSCSA affects your pharmacy.
State licensing
- Florida Statute §499
- Fla. Admin. Code 61N‑1
- What it requires
- States license reverse distributors under rules that vary from one state to the next. In Florida, that means the Florida Drug and Cosmetic Act (Chapter 499) and the rules of the Division of Drugs, Devices and Cosmetics.
- How we meet it
- Ecopharm is licensed in Florida by the Department of Business and Professional Regulation, with state licenses where we operate. We also verify every customer's State License and DEA certification before the first return.
Accreditation, transport and records
NABP accreditation
Drug Distributor Accreditation from the National Association of Boards of Pharmacy. Verify the badge.
Department of Transportation
Shipments packaged and transported in line with U.S. Department of Transportation requirements.
Audit‑ready records
Documentation for every return and every destruction, kept ready for your audits and surveys.
Regulatory reference
Which regulations does Ecopharm comply with?
DEA, EPA, RCRA, DSCSA and FDA regulations at the federal level, and Florida's drug laws alongside the board of pharmacy rules of each state we serve.
DEA compliance
- 21 CFR 1301
- 21 CFR 1305
- 21 CFR 1317
Registration of controlled substance handlers, DEA Form 222 for Schedule I and II orders, and the rules for disposing of controlled substances, including through a reverse distributor.
EPA compliance
- 40 CFR 261.33
- 40 CFR Part 266 Subpart P
- 40 CFR 273
Listed commercial chemical products, the management standards for hazardous waste pharmaceuticals, and universal waste.
RCRA compliance
- 40 CFR 261
- 40 CFR 262
How hazardous waste is identified and listed, and the standards that apply to the facilities that generate it.
DSCSA compliance
- 21 USC 360eee
The Drug Supply Chain Security Act: product tracing, verification and the requirements placed on trading partners.
FDA GMP compliance
- 21 CFR 211
- 21 CFR 314
Current good manufacturing practice for finished pharmaceuticals, and the rules for applications to market a drug.
State regulation
- Florida Statute §499
- Florida Administrative Code 61N‑1
The Florida Drug and Cosmetic Act and the rules of the Division of Drugs, Devices and Cosmetics, alongside the board of pharmacy rules of each state we serve.
Controlled substances
How does DEA Form 222 work?
Schedule II products travel on a DEA Form 222. Ecopharm sends you a C2 Kit with the form and a return label, and you ship the product against it, with a copy of the form and your inventory.
Step 01
Separate inventory
The software prompts controlled substances as their own inventory.
Step 02
Exact counts
Each item is counted or measured to the exact amount.
Step 03
Submit the return
Your return is submitted and reviewed by our team.
Step 04
C2 Kit arrives
We send your DEA Form 222 and a return shipping label.
Step 05
Pack with copies
Include a copy of your inventory and of your DEA Form 222.
Step 06
Ship and track
The package ships to Ecopharm and is tracked to receipt.
Schedule II
Shipped separately with a DEA Form 222
Packed in the tamper‑proof bag we provide
Sent while the form is valid: 60 days from its execution
Form 222 records kept for two years (21 CFR 1305.17)
Schedules III to V
Included on the inventory list
Bagged separately within the same box
Labeled with your return number (RO#)
Non‑returnable
Routed to destruction under DEA disposal rules (21 CFR 1317)
Controlled substance waste, Schedules I to V
Records kept for your audits
Compliance officer questions
Controlled substances, answered
Does Ecopharm handle controlled substances?
Yes. When you return controlled substances, our software prompts them as a separate inventory. Count or measure each item to the exact amount. Once you submit the return, Ecopharm sends you a C2 Kit containing your DEA Form 222 and a return shipping label. Package the product carefully and include a copy of your inventory and a copy of your DEA Form 222.
How do we pack Schedule III to V items?
Non‑controlled and CIII–CV medications must include an inventory list. Bag CIII–CV items separately within the same box and label them with your return number (RO#). CII medications ship separately with a DEA Form 222, using the tamper‑proof bag, label and shipping materials we provide.
How long must DEA Form 222 records be kept?
Two years. DEA Forms 222 must be kept available for inspection for two years (21 CFR 1305.17). A form is valid for 60 days after it is executed, so ship your Schedule II return promptly once your C2 Kit arrives.
Is Ecopharm licensed?
Yes. Ecopharm is registered with the DEA as a reverse distributor, licensed in Florida by the Department of Business and Professional Regulation and accredited by NABP as a Drug Distributor. See Compliance for what each framework requires of our process.
How do we request compliance documents?
Book a call or email us. Tell us what your diligence or audit requires and we'll send the licensing and registration documents you need.
DSCSA
What is DSCSA?
The Drug Supply Chain Security Act (21 USC 360eee) sets up electronic, interoperable tracing of prescription drugs at the package level. As dispensers, pharmacies must work with authorized trading partners, keep transaction records and investigate suspect product. We help simplify the transition.
Key date
Small‑dispenser exemption ends
In August 2026, FDA extended the DSCSA exemption for small business dispensers, those with 25 or fewer full‑time pharmacists and pharmacy technicians, by one year. The requirements already apply to all other dispensers.
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Purpose
Created to prevent counterfeit, contaminated or otherwise unsafe drugs from reaching consumers.
Traceability
Every step, from the manufacturer to the pharmacy, must be documented as drugs move through the supply chain.
Verification
Companies must be able to verify their products. A suspect drug must be investigated and verified.
Licensing
Entities in the supply chain, such as wholesalers and repackagers, must be properly licensed.
Communication
Information about each shipment, its origin, handling and destination, is shared among trading partners.
Our goal
To be a resource that helps our customers understand and navigate these requirements.
How it affects your pharmacy
What does DSCSA require of pharmacies?
Seven things: verify your suppliers, keep transaction records for at least six years, trace products, handle suspect product, buy only from compliant partners, upgrade your systems and train your staff.
- Verify legitimacyMake sure drug suppliers are authorized and licensed.
- Keep recordsMaintain transaction records for at least six years.
- Trace productsStore transaction information to trace drugs to their origin.
- Handle suspect productsInvestigate and act on potentially unsafe drugs.
- Work with compliant partnersOnly purchase from DSCSA‑compliant suppliers.
- Upgrade systemsInvest in tracking, tracing and record‑keeping technology.
- Train staffEducate employees on DSCSA requirements and procedures.
- Get expert guidanceTalk to our team about DSCSA and software options.
How Ecopharm helps
Get fully compliant before your next audit
Eliminate manual tracking and documentation
Reduce the risk of compliance gaps and penalties
Maintain organized, audit‑ready records
Simplify operational changes
Who this is for
Independent pharmacies
Pharmacy chains
Clinics and healthcare providers
Dispensers handling prescription drugs
Document requests
How can compliance officers request documents?
Book a call with our team, or email us. We send the licensing, registration and accreditation documents that apply to your review, and answer your questions about our processes.
Commonly requested
DEA registration
State licenses
NABP Drug Distributor Accreditation
Destruction documentation for your returns
Summaries of our handling processes
DSCSA
Don't wait for a failed audit
Get DSCSA ready with Ecopharm and simplify your compliance process.
