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 ----------------------------------------------------------------- |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 | | | | | | ----------------------------------------------------------------- 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 AB 1442 Page 2 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 AB 1442 Page 3 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, AB 1442 Page 4 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 AB 1442 Page 5 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