40 CFR Part 266 Subpart P
Regulatory Relief - Ahhhh
The following regulations are considered regulatory relief from the current regulations found in 40 CFR Part 262.
NICOTINE EXEMPTION - P075 - 40 CFR 261.33(e)
- FDA-approved OTC nicotine replacement therapies (NTR’s) are exempted from the P075 listing.
- The exemption only applies to patches, gums and lozenges.
- The exemption does not apply to nicotine containing e-cigarettes, e-liquids or prescription NRT’s.
- Since this regulation is less stringent than what is currently enforced, individual states must adopt it. Check with your state.
DEA/HWP - 40 CFR 266.506
(DEA controlled substances that are also Hazardous Waste Pharmaceuticals)
DEA controls are not hazardous waste if:
- DEA regulations are followed;
- DEA controls are disposed of through incineration at a permitted combustor (5 types allowed) or other DEA publicly approved method.
- IMPORTANT - This regulation does not override the sewer ban of HW Pharmaceuticals. Even for pharmaceuticals that are considered "Pharmaceutical Wastage" by the DEA (DEA letter to Practitioners - 10/17/2014). If a pharmaceutical is both DEA controlled and hazardous waste, even the left over waste after administration is prohibited from being drain disposed.
- None of the 3rd party disposal technologies for pharmaceutical wastage disposal that are designed to be placed in the regular trash have received DEA public approval to render DEA controls non-retrievable. Therefore, do not use these devices for DEA/HWP disposal as described in this scenario. Medicine Disposal Products Review
EMPTY CONTAINERS
- 40 CFR 266.507(a)
A container (including residue) that contained a hazardous waste pharmaceutical is considered RCRA empty when:
- all contents of the container are removed by practices commonly employed (normal means).
- Containers include: stock and dispensing bottles, vials, ampules and unit dose containers.
- Unit dose container include: unit dose packet, cup, wrapper, blister pack, or delivery device.
- This applies to drug containers up to 10,000 tabs or 1 liter if a liquid.
- Regulatory relief on containers and residue does not apply to: aerosols, tubes, gels, creams, ointments and nebulizers. However, it is still possible for these other containers to be RCRA empty if contents are non-acute HW and meet the requirements under § 261.7(b)(1).
EMPTY SYRINGES - 40 CFR 266.507(b)
A syringe (including residue) that contained a hazardous waste pharmaceutical is considered RCRA empty when:
- the contents have been removed by "fully depressing the plunger" of the syringe.
- Hazardous waste pharmaceuticals in used syringes without fully depressed plungers need to be treated as non-creditable hazardous waste pharmaceuticals.
- State and local sharps/medical waste regulations may apply.
EMPTY IV BAGS - 40 CFR 266.507(c)
An Intravenous bag (including residue) that contained a hazardous waste pharmaceutical is considered RCRA empty when:
- the contents have been fully administered to the patient (including tubing).
- HW pharmaceuticals in used IV bags that have not been fully administered are to be treated as non-creditable hazardous waste pharmaceuticals, unless they are non-acute HW and RCRA empty under § 261.7(b)(1).
HWP GENERATED WEIGHT - does not count towards generator status
- You must be operating under Subpart P for this relief.
- This may impact your facility's generator status.
- The lower your generator status, the less stringent the regulations that apply.
- Determine your Generator Status
NO SAA OR CAA REQUIREMENTS
- Previously there were regulations regarding the amount of hazardous waste pharmaceuticals that were able to be stored and for how long in the SAA (Satellite Accumulation Areas) and CAA (Centralized Accumulation Areas) for LQGs (Large Quantity Generators) and SQGs (Small Quantity Generators).
HAZARDOUS WASTE - special circumstances
- EPA does not consider pharmaceuticals being RCRA hazardous waste until such decision is made to dispose of them in the instances of: recalls, preservation orders, investigations, judicial proceedings.
NO BIENNIAL REPORTING OF HWPs - 40 CFR 266.503(d)
- Your healthcare facility is not subject to biennial reporting requirements for the potentially creditable and non-creditable hazardous waste pharmaceuticals generated at your facility.
- Check with your state as they may have stricter reporting requirements.
DEA AUTHORIZED ONSITE COLLECTION RECEPTACLES
- LTCF Only
- Hazardous waste (including non-pharmaceuticals) from LTCF's are not considered exempt as household hazardous waste.
- Most LTCF's are not DEA registrants.
- LTCF's that are VSQG's can dispose of HW Pharmaceuticals (excludes PPE and cleanup residue) through the use of an onsite DEA authorized collection receptacle..
- LTCF & Retail Kiosks
- Per DEA regulations, only household (Ultimate User) pharmaceuticals can be placed in container.
- A facility that is a DEA registrant, CANNOT put their HW Pharmaceuticals in the receptacle as this would be a violation of DEA regulations.
- Check with your state to see if they have additional solid waste licensing or permitting regulations.
HOUSEHOLD HAZARDOUS WASTE EXCLUSION - 40 CFR 261.4 (b)(1)
- Hazardous wastes generated by households that are not regulated by RCRA. No change in EPA's definition of household, but important to point out criteria used to determine what constitutes household HW.
- Household hazardous waste criteria
- Generated by individuals on the premise of a temporary or permanent residence
- Waste stream primarily composed of materials found in wastes generated by consumers in their homes.
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