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CLSA Wire

Governor Brown Signs SB 212 to Establish a Statewide Drugs & Sharps Take-Back Program

October 23, 2018
By Brett Johnson

On the final day for signing or vetoing bills, California Gov. Jerry Brown signed into law SB 212 (Jackson), which establishes a comprehensive statewide take-back system for sharps and medications. California is first in the nation to establish a comprehensive, producer-funded take-back program to provide safe and convenient disposal options for both home-generated pharmaceutical drugs and sharps waste.

In a statement, Sara Radcliffe, President and CEO of CLSA, said, “SB 212 represents a hard-negotiated compromise among numerous stakeholders that haven’t always seen eye-to-eye on the matter. CLSA has always worked to reach a consensus on finding a workable, statewide solution that puts patients first. As compromises often work, nobody got everything they wanted, but the alternative to this bill is something nearly all stakeholders involved wanted to avoid: years of a growing patchwork of local take-back programs potentially differing across as many as 58 counties and even more cities. We thank Governor Brown for signing SB 212 into law.”

Of interest to the life sciences sector, SB 212 included the following with regards to the statewide drugs and sharps take-back program:

  • Provides a number of key exemptions from the products covered by stewardship plans:

o    Biological drug products;

o    Combination products that include biologics;

o    Saline solutions used in kidney dialysis;

o    Medicines intended for animals; and

o    Insulin pump therapy systems and continuous glucose monitors, including all components.

  • Excludes drugs or sharps discarded by needle exchange programs or medical waste generators (e.g., healthcare facilities or home healthcare agencies).
  • Preempts all local drugs or sharps stewardship programs enacted by ordinances effective on or after April 18, 2018 and does not require compliance where such an ordinance is in effect.
  • Prohibits any local drugs or sharps stewardship programs enacted prior to April 18, 2018 from receiving funds available under this statewide program unless the local program is dissolved.

The Governor’s signing message stated that “last minute amendments created ambiguity that might impact the effectiveness of this program” and urged the legislature to ensure CalRecycle has the “appropriate enforcement tools to ensure compliance and that the program offers the level of collection the author envisioned.” The message refers to concerns that the definition of which entities can be held responsible for noncompliance with the law’s requirements may contain gaps making its enforcement difficult. CalRecycle does, however, have explicit rulemaking authority under the law to further define such entities, so CLSA will be closely monitoring all potential SB 212-related rulemaking going forward.

Click here for the final bill language and legislative analyses. For additional information, please contact Oliver Rocroi, CLSA’s Senior Director of State Government Relations (orocroi@califesciences.org).