BILL ANALYSIS Ó AB 1442 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 1442 (Wieckowski) As Amended August 21, 2012 Majority vote ----------------------------------------------------------------- |ASSEMBLY: |78-0 |(May 30, 2012) |SENATE: |37-0 |(August 27, | | | | | | |2012) | ----------------------------------------------------------------- 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.): AB 1442 Page 2 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 AB 1442 Page 3 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 AB 1442 Page 4 "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