BILL ANALYSIS �
AB 1442
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB 1442 (Wieckowski)
As Amended August 21, 2012
Majority vote
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|ASSEMBLY: |78-0 |(May 30, 2012) |SENATE: |37-0 |(August 27, |
| | | | | |2012) |
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Original Committee Reference: E.S. & T.M.
SUMMARY : Authorizes the transportation of pharmaceutical waste,
as defined, by a common carrier.
The Senate amendments:
1)Clarified that pharmaceutical waste sent to out of the state
must be sent to facilities licensed by the California the
Board of Pharmacy (BOP), but they are not required to be
licensed as a transfer facility by the Department of Public
Health.
2)Required pharmaceutical waste generators to notify the
enforcement agencies in the event that there is a discrepancy
in tracking document for the shipment of pharmaceutical waste.
3)Required that the pharmaceutical waste that is separated from
medical waste by the generator be maintained in a manner to
secure the pharmaceutical waste contents from unauthorized
individuals.
EXISTING LAW:
1)Regulates, under the federal Resource Conservation and
Recovery Act (RCRA), the management of solid and hazardous
wastes.
2)Regulates, under the Radiation Control Law (Health and Safety
Code Section 114960 et seq.) and controls sources of ionizing
radiation.
3)Specifies, under the Medical Waste Management Act (MWMA)
(Section 117600 et seq.):
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a) Defines "pharmaceuticals" as a prescription or
over-the-counter human or veterinary drug including, but
not limited to, a drug as defined in the Sherman Food, Drug
and Cosmetic Law or the Federal Food, Drug, and Cosmetic
Act. "Pharmaceutical" does not include any pharmaceutical
that is regulated pursuant to either RCRA or the Radiation
Control Law.
b) Specifies that waste comprised only of pharmaceuticals
is hazardous, and is considered "medical waste," although
it is not subject to hazardous waste laws, as specified.
c) Requires medical waste generators to maintain on file,
or file with the enforcement agency, specified documents
relating to the maintenance, treatment and transport of
medical waste.
d) Requires all medical waste be transported to an offsite
medical waste treatment facility to be transported by a
registered hazardous waste transporter.
e) Requires that medical waste treatment facilities
maintain specified records for three years, including
copies of the tracking documents for all medical waste it
receives for treatment from offsite generators or hazardous
waste haulers.
AS PASSED BY THE ASSEMBLY , this bill was substantially similar
to the version passed by the Senate.
FISCAL EFFECT : According to the Senate Appropriations
Committee, enactment of this act would result in a cost of
$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. The bill
will result in $160,000 annually thereafter 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
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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,
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 California Department of Public
Health (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 (Health and Safety Code
(HSC) Section 117690). For purposes of the MWMA, the term
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"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
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 : Bob Fredenburg / E.S. & T.M. / (916)
319-3965
FN: 0005731