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Very Small Quantity Generator - Healthcare Facilities

Provided below is a summary of the regulatory requirements for Healthcare Facilities (HFs) that are Very Small Quantity Generators (VSQGs) for the total of their hazardous waste pharmaceuticals (HWPs) and their non-pharmaceutical hazardous waste (HW) and facilities accepting potentially creditable HWPs and non-creditable HWPs from VSQGs that are not Reverse Distributor. Prior to the HW Pharmaceuticals Rule, HFs were required to manage their HWPs as hazardous waste subject to all the hazardous waste generator management requirements of the Virginia Hazardous Waste Management Regulations (VHWMR.) VSQGs have multiple options for managing HWPs under the Pharmaceuticals Rule.

Regulatory Requirements for VSQG HF

All Healthcare Facilities (HFs), including VSQGs, must comply with the Hazardous Waste Pharmaceuticals (HWPs) sewer prohibition in Part 266, Subpart P. HFs that qualify as VSQGs for their total count of HWPs plus non-pharmaceutical HW can maintain their conditional exemption by managing all of their Hazardous Waste (HW) and HWPs under the VSQG generator requirements of 40 CFR § 262.14.

A Healthcare Facility that is a VSQG for both HWPs and non-pharmaceutical HW has the following additional options for managing HWPs:

  • Send its potentially creditable HWPs to a reverse distributor (RD) while managing its non-creditable HWP as HW; or
  • Send both its potentially creditable and non-creditable HWPs off-site to another HF; provided:

Long-term Care Facilities - VSQG

Long-term Care Facilities (LTCFs) that are VSQGs for both HWPs and non-pharmaceutical HW may dispose of their HWPs (excluding contaminated personal protective equipment or clean-up materials) in an on-site collection receptacle of an authorized collector (as defined by the Drug Enforcement Administration (DEA) that is registered with the DEA, provided that the contents are collected, stored, transported, destroyed and disposed of in compliance with all applicable DEA regulations for controlled substances.

A LTCF with 20 beds or fewer is presumed to be a VSQG subject to the VSQG generator regulations for both HWPs and non-pharmaceutical HW. However, the VSQG can choose to comply with applicable portions of Part 266 Subpart P (except for the sewer prohibition and RCRA empty container definition which apply to all HFs) and the other optional provisions of Subpart P. For an LTCF with less than 20 beds that DEQ believes to be generating greater than VSQG quantities, DEQ has the responsibility to demonstrate that the LTCF generates quantities of HW that are in excess of the VSQG limits of no more than 1 kg acute hazardous waste and no more than 100 kg non-acute hazardous waste generated per calendar month. A LTCF with more than 20 beds that operates as a VSQG must demonstrate to DEQ upon request that it generates quantities of HW that are within the VSQG limits as defined above.

Facilities that Accept Potentially Creditable HWPs and Non-Creditable HWPs from VSQGs

A Healthcare Facility (HF) that is a VSQG can send both its potentially creditable Hazardous Waste Pharmaceuticals (HWPs) and non-creditable (including commingled) HWPs to an off-site HF operating under Subpart P. provided the receiving HF complies with the regulations for receiving HFs which are found in 40 CFR § 266.502(l) and as described for non-creditable HWPs and in 40 CFR § 266.503(b) for potentially creditable HWPs.

A HF may accept potentially creditable and/or non-creditable HWPs from an off-site HF that is a VSQG provided the receiving HF:

  • Is under the control of the same person, as defined in 40 CFR § 260.10, or has a contractual or other documented business relationship whereby the receiving HF supplies pharmaceuticals to the VSQG healthcare facility;
  • Is operating under Subpart P for the management of HWPs;
  • Manages the HWPs that it receives from off site in compliance with Subpart P; and
  • Keeps records of the potentially creditable HWPs shipments it receives from off site for three years from the date that the shipment is received.

It is important to note that a VSQG HF that chooses to consolidate its HWPs at an off-site HF is not considered to be operating under Subpart P, and does not need to notify as a VSQG operating under Subpart P. However, a VSQG HF that chooses to opt into Subpart P and send its potentially creditable HWPs to an RD does need to notify that they are operating under Subpart P.

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Virginia Department of
Environmental Quality
P.O. Box 1105
Richmond, VA 23218
(804) 698-4000

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