BILL ANALYSIS Ó SB 431 Page 1 Date of Hearing: August 17, 2011 ASSEMBLY COMMITTEE ON APPROPRIATIONS Felipe Fuentes, Chair SB 431 (Emmerson) - As Amended: May 10, 2011 Policy Committee: HealthVote:11-2 Business and Professions Vote: 9-0 Urgency: No State Mandated Local Program: Yes Reimbursable: No SUMMARY This bill modifies existing reporting requirements to the Board of Pharmacy (Board) regarding employee theft of drugs, prohibits a pharmacist whose license has been revoked from dispensing medication via mail, and prohibits reverse distributors (who dispose of unusable drugs) from accepting prescription drugs that have been dispensed to a patient and later returned to the pharmacy, unless certain conditions are met. FISCAL EFFECT Minor and absorbable costs to the state Board of Pharmacy for enforcement of this measure. COMMENTS 1)Rationale . According to the author, this bill contains consumer protection measures that improve the Board's oversight and enforcement activities. This bill attempts to address three separate problems: prescription drug theft, pharmacists with revoked licenses who are providing prescription drugs through the mail, and improper disposal of prescription drugs. First, the provision that requires more rapid and complete reporting of cases of drug theft will allow the Board to respond more quickly and effectively to such cases. The provision that prohibits a pharmacist whose license has been revoked in the state to distribute prescription drugs via mail closes a loophole that undermines the Board's public protection efforts. Finally, the Board contends that the provision relating to SB 431 Page 2 reverse distributors clarifies that reverse distributors are able to continue removing drugs from the drug supply chain under certain circumstances. 2)Disposal of Pharmaceutical Waste . According to the US Food and Drug Administration, proper disposal of home-generated pharmaceutical waste (HGPW) is important to address the potential for misuse, as well as contamination of water that occurs when drugs are improperly flushed down the toilet. Some other states have established drug take-back programs at pharmacies for consumers to dispose of their unused drugs. A report by the California Department of Resources Recycling (CalRecyle) submitted to the Legislature this March pursuant to SB 966 (Simitian), Chapter 542, Statutes of 2007 lays out several policy options related to improving disposal of HGPW, including establishing pharmacy take-back programs. In addition, this report indicates that recent federal legislation, the Secure and Responsible Drug Disposal Act of 2010, gives the federal government more flexibility in developing regulations that would allow public and private entities to operate a variety of effective and safe collection and disposal methods for controlled substances. Reverse distributors accept expired or otherwise unusable drugs from pharmacies and properly dispose of them, including sending the drugs back to manufacturers for credit or incinerating them. This bill prohibits a reverse distributor from accepting the return of drugs that have been dispensed to patients and returned to the pharmacy unless there is no evidence that the package was opened damaged, or tampered with. In this way, the bill limits the ability of reverse distributors to accept HGPW, and essentially limits the ability of reverse distributors to participate in pharmaceutical take-back programs for HGPW that are contemplated by the DRRR report and by pending federal regulations. 3)Opposition Concerns . Concerns about the provision related to the ability of reverse distributors to accept HGPW have been raised by the Bay Area Pollution Prevention Group, a pollution watchdog, as well as by EXP Pharmaceutical Services Corp., one of California's few reverse distributors. EXP indicates that this bill's provisions may conflict with federal regulations, among other concerns. EXP also points out that reverse SB 431 Page 3 distributors have expertise in handling pharmaceutical waste and can do so cheaply and effectively, and with stricter oversight and control than hazardous waste haulers, which is the alternative disposal route. Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081