BILL ANALYSIS Ó
AB 1442
Page 1
ASSEMBLY THIRD READING
AB 1442 (Wieckowski)
As Amended March 27, 2012
Majority vote
ENVIRONMENTAL SAFETY 8-0APPROPRIATIONS 17-0
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|Ayes:|Wieckowski, Miller, |Ayes:|Fuentes, Harkey, |
| |Campos, Chesbro, Davis, | |Blumenfield, Bradford, |
| |Donnelly, Feuer, Morrell | |Charles Calderon, Campos, |
| | | |Davis, Donnelly, Gatto, |
| | | |Ammiano, Hill, Lara, |
| | | |Mitchell, Nielsen, Norby, |
| | | |Solorio, Wagner |
| | | | |
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SUMMARY : Authorizes the transportation of pharmaceutical waste,
as defined, by a common carrier. Specifically, this bill :
1)Defines "common carrier" as either of the following:
a) A person or company that has a United States Department
of Transportation number issued by the Federal Motor
Carrier Safety Administration and is registered with the
Federal Motor Carrier Safety Administration as a for-hire
property carrier.
b) A person or company that has a motor carrier of property
permit issued by the Department of Motor Vehicles pursuant
to the Motor Carriers of Property Permit Act and, if
applicable, a carrier identification number issued by the
Department of the California Highway Patrol.
2)Defines "pharmaceutical waste" as any pharmaceutical that for
any reason may no longer be sold or dispensed for use as a
drug. Excludes from this definition those pharmaceuticals
that still have potential value to the generator because they
are being returned to a reverse distributor for possible
manufacturer credit.
3)Authorizes a medical waste generator or parent organization
that employs health care professionals who generate
pharmaceutical waste to apply to the enforcement agency for a
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pharmaceutical waste hauling exemption if the generator,
health care professional, or parent organization meets all of
the following requirements:
a) The generator or parent organization has on file one of
the following:
i) If the generator or parent organization is a small
quantity generator required to register with the
enforcement agency, the required medical waste management
plan, as defined in statute.
ii) If the generator or parent organization is a small
quantity generator not required to register, the
information document, as defined in statute.
iii) If the generator or parent organization is a large
quantity generator, a medical waste management plan, as
defined in statute.
b) The generator or health care professional who generated
the pharmaceutical waste transports the pharmaceutical
waste himself or herself, or directs a member of his or her
staff to transport the pharmaceutical waste to a parent
organization or another health care facility for the
purpose of consolidation before treatment and disposal, or
contracts with a common carrier to transport the
pharmaceutical waste to a permitted medical waste treatment
facility or transfer station.
c) The generator and the facility receiving the medical
waste maintain a tracking document, as defined in statute.
d) The health care professional who generates and returns
the pharmaceutical waste to the parent organization for the
purpose of consolidation before treatment and disposal is
authorized to substitute a single-page form or multiple
entry log for the tracking document if the form or log
contains specified information.
4)Clarifies that this bill does not prohibit the use of a single
document to verify the return of more than one container to a
parent organization or another health care facility for the
purpose of consolidation before treatment and disposal over a
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period of time, if the form or log is maintained in the files
of the parent organization or another health care facility
that receives the waste once the form or log is completed.
5)Requires the form or log to be maintained in the files of the
health care professional who generates the pharmaceutical
waste and the parent organization or another health care
facility that receives the waste.
6)Makes other conforming changes.
FISCAL EFFECT : According to the Assembly Appropriations
Committee, enactment of this bill would have the following
fiscal effect:
1)Annual special fund costs of approximately $280,000
(equivalent to three positions) in 2012-13 through 2014-15 to
the California Department of Public Health (CDPH)-the state
agency that enforces medical waste transport-to coordinate
with stakeholders statewide, oversee rulemaking process and
develop regulations.
2)Annual special fund costs of approximately $159,000
(equivalent to two positions) to the department to review
exemption requests and ensure compliance with documentation
requirements.
COMMENTS :
Need for the bill : According to the author, "Under existing
law, pharmaceutical drugs can be sent to health care facilities
through standard common carriers, or standard shipping means.
Unused drugs can sometimes be returned to the manufacturer for
credit, via a common carrier. Expired and non-dispensable drugs
must be shipped as "Medical Waste," requiring expensive
hazardous waste shipping, instead of common carrier. This is
unnecessarily expensive for pharmacies, hospitals, and other
health care facilities, who are simply returning the exact same
drug that was shipped to them by common carrier."
Regulation of pharmaceutical waste under the Medical Waste
Management Act (MWMA) : Pharmaceutical wastes that must be
managed according to the MWMA are those that are classified as
"California only hazardous waste" by Chapter 11, Title 22,
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California Code of Regulations. If a pharmaceutical waste meets
the criteria of a California hazardous waste, it must be
segregated in an appropriate container, properly labeled,
stored, manifested, transported and incinerated at a regulated
medical waste incinerator or destroyed through another method
approved by the CDPH. The MWMA prohibits a person from hauling
medical waste unless the person is either a registered hazardous
waste hauler or has an approved limited-quantity exemption.
Reverse distribution and transporting pharmaceutical waste : It
is common practice for pharmacies and other health care
facilities to return unused pharmaceuticals to the manufacturer
for credit or disposal. Health care facilities have the option
of hiring reverse distributors to manage their unused and/or
expired medication that could be returned to the manufacturer or
wholesaler for credit. The reverse distributor determines which
medications may be returned to the manufacturer or wholesaler
for credit and arranges for disposal of unused medications that
are waste. Once the unused pharmaceutical is determined to be
ineligible for credit, it becomes waste and must be managed as
such.
In California, reverse distributors are regulated by both the
Board of Pharmacy (BOP) and the CDPH. The BOP regulates
activities involving "dangerous drugs," as defined in Business
and Professions Code (BPC) Section 4022, which includes
prescription medications. Reverse distributors that intend to
receive "outdated or nonsalable dangerous drugs," which could
include potentially creditable drugs, must register with the BOP
as "drug wholesalers" (BPC Sections 4040.5, 4043 and 4160).
However, once a pharmaceutical is designated as "medical waste"
pursuant to the MWMA, it is regulated by the CDPH (HSC Section
117690). For purposes of the MWMA, the term "pharmaceutical"
isn't restricted to "dangerous drugs" as set forth in the BPC,
but rather is intended to cover all pharmaceuticals, including
both prescription and over-the-counter drugs (HSC Section
117747).
The MWMA requires that medical waste pharmaceuticals be sent to
reverse distributors via a licensed hazardous waste hauler (HSC
Section 118000). However, according to DPH's Self-Assessment
Manual for Proper Management of Medical Waste, pharmaceuticals
that have "intrinsic value" (such as outdated or otherwise
unsalable pharmaceuticals that are returned for credit) are not
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considered "waste" and, thus, may be shipped to a reverse
distributor via a common carrier. Therefore, under current law,
whether or not a pharmaceutical is creditable determines whether
it must be transported via a registered waste hauler or is
authorized to be transported via common carrier. As is
authorized under current law for outdated or otherwise unsalable
creditable pharmaceuticals, this bill authorizes the
transportation of outdated or otherwise unsalable non-creditable
pharmaceuticals, which are designated as medical waste, via a
common carrier.
Analysis Prepared by : Shannon McKinney / E.S. & T.M. / (916)
319-3965
FN: 0003861