Regulatory Compliance
Our take-back programs are designed to meet regulatory standards, ensuring that all materials are collected, processed, and documented responsibly. Our compliance framework provides partners and customers with confidence that their participation aligns with legal and environmental requirements that protect the environment, uphold safety standards, and ensure accountability at every stage.
Inner Liner Requirements
Title 21 CFR 1317.60
According to the Drug Enforcement Administration, when operating a take-back program, the inner liner used in an approved collection receptacle shall meet the following requirements:
- The inner liner shall be waterproof, tamper-evident, and tear-resistant;
- The inner liner shall be removable and sealable immediately upon removal without emptying or touching the contents;
- The contents of the inner liner shall not be viewable from the outside when sealed;
- The size of the inner liner shall be clearly marked on the outside of the liner (e.g., 5-gallon, 10-gallon, etc.); and
- The inner liner shall bear a permanent, unique identification number that enables the inner liner to be tracked.
For complete information on the disposal of controlled substances collected from ultimate users and other non-registrants, see Title 21 CFR Part 1317, Subpart B (§§ 1317.30–1317.85).
Access to the inner liner shall be restricted to employees of the collector. The inner liner shall be sealed by two employees immediately upon removal from the permanent outer container and the sealed inner liner shall not be opened, x-rayed, analyzed, or otherwise penetrated.
Packaging Compliance
DOT Special Permits
ARXG works with DEA-authorized registrants including federal, state, tribal, and local law enforcement to collect post-consumer pharmaceutical waste for proper end-of-life management, fully compliant with federal Hazardous Materials Regulations across all approved transport modes.
We are authorized by the Department of Transportation to transport approved materials permitted to be disposed of under 21 CFR Part 1317, Subpart B.
Our packaging meets strict federal requirements, including:
- Inner Packaging: An inner liner bag meeting the requirements of 21 CFR 1317.60. Additionally, inner liner bags must meet the requirements of 49 CFR 173.197(e)(1)(i) and (ii) or be further packaged in film bags meeting these requirements.
- Outer Packaging: Strong outer packaging (i.e., fiberboard, plastic, or metal). Completed packages must be capable of meeting the PG II performance level. Multiple inner packagings may be placed in the outer packaging.
- The total weight of the packaging plus its contents shall not exceed 66 pounds.
For complete information on outer packaging and performance standards under DOT regulations, including 49 CFR 173.197(e) and PG II requirements, please consult Title 49, CFR Part 173, Subpart E (§§173.158–173.232).
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1010 Summit Ave N
Sauk Rapids,
MN 56379
Call Sales +1 (855) 269-1750
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