Earlier this month, the California State Senate passed SB 212, via unanimous vote. The bill aims to establish a statewide take-back system for sharps and medications. If signed into law by Governor Jerry Brown, the law will be first in the nation to establish a comprehensive and producer-funded take-back program.
Current regulations allow pharmacies, hospitals or clinics with onsite pharmacies, distributors, and reverse distributors licensed by the California State Board of Pharmacy to offer specified prescription drug take-back services through collection receptacles or mail back envelopes or packages to provide options for the public to discard unwanted, unused, or outdated prescription drugs.
However, implementation of this bill would establish a stewardship program, under which a manufacturer or distributor of covered drugs or sharps, or other entity defined to be covered by the bill, would be required to establish and implement, either on its own or as part of a group of covered entities through membership in a stewardship organization, a stewardship program for covered drugs or for sharps, as applicable.
The bill would also impose various requirements on a covered entity or stewardship organization that operates a stewardship program, including submitting the following information to CalRecycle: a proposed stewardship plan, an initial stewardship program budget, an annual budget, and an annual report. The bill would require that all reports and records provided to CalRecycle pursuant to the bill are done so under penalty of perjury. By expanding the scope of the crime of perjury, the bill would impose a state-mandated local program. The bill would require proprietary information, as defined, submitted pursuant to the bill to be kept confidential.
The bill would require each covered entity, either individually or through the stewardship organization of which it is a part, to pay all administrative and operational costs associated with establishing and implementing the stewardship program in which it participates. The bill would also require a covered entity to pay a quarterly administrative fee in an amount adequate to cover any regulatory costs incurred by a state agency in administering and enforcing the provisions of the bill, to be deposited in the Pharmaceutical and Sharps Stewardship Fund, which the bill would create. The bill would then authorize money in the fund to be expended via appropriation by the Legislature for the regulatory activities of state agencies of administering and enforcing the bill.
The effective date of the law would be no later than January 1, 2010.
“The California Product Stewardship Council has worked tirelessly for the last eight years to get the pharmaceutical industry to work with us to put in place a statewide take-back program,” said Heidi Sanborn, senior advisor and former executive director of the California Product Stewardship Council (CPSC), in a statement. “It took passing nine county ordinances and the hard work of Senator Jackson and Assembly member’s Ting and Gray as well as many others to successfully negotiate a compromise with the pharmaceutical industry to make this happen. This is a public health and safety bill whose time has come, and we sincerely hope that Governor Brown will sign this into law.”