BILL ANALYSIS �
Senate Appropriations Committee Fiscal Summary
Senator Christine Kehoe, Chair
AB 1442 (Wieckowski) - Pharmaceutical waste.
Amended: August 6, 2012 Policy Vote: EQ 7-0
Urgency: No Mandate: Yes
Hearing Date: August 16, 2012 Consultant:
Bob Franzoia
SUSPENSE FILE. AS PROPOSED TO BE AMENDED.
Bill Summary: AB 1442 would exempt a pharmaceutical waste
generator or parent organization from medical waste hauling
requirements if the generator or parent organization meets
documentation and other requirements. This bill would authorize
pharmaceutical waste to be transported by the generator or
parent organization
Fiscal Impact: $280,000 from the Medical Waste Management Fund
in 2013-14 and 2014-15 for two full time and one limited term
Department of Public Health staff to coordinate with
stakeholders statewide, oversee rulemaking process and develop
regulations.
$160,000 annually thereafter to review exemption requests
and ensure compliance with documentation requirements.
Background: As noted by the policy committee, some
pharmaceutical wastes are classified as hazardous wastes.
Others are medical waste, and still others are nonhazardous
wastes. Which category a discarded pharmaceutical falls into
depends on its chemical, physical, and toxicological properties
and who generates the waste. The California Code of Regulations
dictates that the generator of the waste is ultimately
responsible for proper classification of waste streams and
subsequently managing and disposing of the waste according to
the appropriate rule governing each waste classification.
The Department of Toxic Substances Control (DTSC) regulates
pharmaceutical wastes that are considered hazardous under
federal Resource Conservation and Recovery Act (RCRA) law. Some
pharmaceutical waste that is not identified under the RCRA may
be deemed hazardous under California standards, and subsequently
classified as medical waste and therefore subject to the Medical
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Waste Management Act (MWMA). The department oversees the MWMA
and regulates medical waste.
The MWMA specifies that medical waste, including pharmaceutical
waste comprised of nonsalable and outdated prescription and
over-the-counter drugs must be transported by a licensed
hazardous waste hauler. If they meet certain requirements,
medical waste generators can apply for a limited-quantity waste
hauling exemption, and the generator of the medical waste may
transfer the waste themselves to a medical waste treatment
facility. These exemptions last one year, and do not allow the
medical waste transporter to contract with a common carrier.
Proposed Law: This bill would define pharmaceutical waste for
the purposes of the MWMA and would exempt a pharmaceutical waste
generator or parent organization that employs health care
professionals who generate pharmaceutical waste from some waste
hauling requirements if (1) the generator, health care
professional, or parent organization retains tracking
documentation and meets requirements intended to ensure secure
transportation and shipping and (2) if the facility receiving
the medical waste retains notification and tracking
documentation and meets records maintenance and reporting
requirements.
This bill would authorize pharmaceutical waste to be transported
by the generator or health care professional who generated the
pharmaceutical waste, a staff member of the generator or health
care professional, or common carrier.
By expanding the definition of a crime, this bill imposes a
state mandated local program. No reimbursement is required.
Staff Comments: Haulers transporting medical waste must first
apply to DTSC to obtain a hazardous waste transporter
registration, including submitting the required transporter fees
to DTSC. After the haulers obtain the hazardous waste
transporter registration, the department will issue a medical
waste transporter registration.
The proposed amendment would revise Health and Safety Code
117748, as added by this bill, to read:
117748. (a) "Pharmaceutical waste" means any pharmaceutical,
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as defined in Section 117747, that for any reason may no longer
be sold or dispensed for use as a drug is a waste, as defined in
Section 25124.
(b) For purposes of this part, "pharmaceutical waste" does not
include any pharmaceutical that meets either of the following
criteria: is outdated or nonsalable and is being returned to a
reverse distributor, as defined in Section 4040.5 of the
Business and Professions Code, that is licensed both as a
wholesaler of dangerous drugs by the California State Board of
Pharmacy pursuant to Section 4160 of the Business and
Professions Code and as a permitted transfer station pursuant to
Section 117775, for possible manufacturer credit.
(1) The pharmaceutical is being sent out of the state of
California to a reverse distributor, as defined in Section
4040.5 of the Business and Professions Code, that is licensed as
a wholesaler of dangerous drugs by the California State Board of
Pharmacy pursuant to Section 4161 of the Business and
Professions Code.
(2) The pharmaceutical is being sent by a reverse
distributor, as defined in Section 4040.5 of the Business and
Professions Code, offsite for treatment and disposal, or to
reserve distributor that is licensed as a wholesaler of
dangerous drugs by the California State Board of Pharmacy
pursuant to Section 4160 of the Business and Professions Code
and as a permitted transfer station if such reverse distributor
is located within the state of California.
(c) Notwithstanding any other provision of law,
pharmaceuticals transferred as described in paragraph (b), are
exempt from the requirements of this part and Chapter 6.5
(commencing with Section 25100) of Division 20.