January 5, 2006
CALIFORNIA LAW ON RECYCLING UNUSED PRESCRIPTION MEDICATIONS
By: John Kasprak, Senior Attorney
You asked for information on a new California law allowing for the “recycling” of unused prescription drugs.
California Senate Bill 798, signed into law by Governor Schwarzenegger in September 2005, authorizes a county to establish a program to collect unused prescription medications from nursing homes, wholesalers, and manufacturers and redistribute them to low-income, uninsured people. (A copy of the law is attached.)
The law authorizes a county to establish, by ordinance, a repository and distribution program to provide surplus unused medications to people in need of financial assistance to ensure access to necessary pharmaceutical therapies. A county choosing to participate in the program must, at a minimum, establish procedures:
1. concerning eligibility for indigent patients who may participate;
2. ensuring that eligible patients are not charged for any medications provided under the program;
3. developing a formulary of appropriate medications for the program;
4. ensuring proper safety and management of any medications collected by and maintained under the authority of a licensed pharmacy; and
5. ensuring the privacy of the individuals for whom the medication was originally prescribed.
The law authorizes any manufacturer legally authorized under federal law to manufacture or sell pharmaceutical drugs or a licensed nursing facility, pharmacy wholesaler, or pharmacy to donate medications pursuant to law. Only county-owned pharmacies or those that contract with the county according to the law can participate in the program to dispense donated medications.
Medication donated to a county's program must not:
1. be a controlled substance;
2. have been adulterated, misbranded, or stored under conditions contrary to standards set by the U.S. Pharmacopoeia (USP) or the product manufacturer; or
3. have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a nursing home, must have been under the control of the facility's staff.
Only medication donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards can be donated to the program, provided that lot numbers and expiration dates are affixed. Medication donated in opened containers cannot be dispensed by the program.
PHARMACISTS' RESPONSIBILITIES AND PROCEDURES
The law specifies that a pharmacist must use his professional judgment in determining whether donated medication meets the law's standards before accepting or dispensing any medication under the program. A pharmacist must follow standard pharmacy practices, as required by state and federal law, when dispensing the medications. Donated medication that does not meet the law's requirements must not be distributed and must be either destroyed or returned to a reverse distributor. The medication cannot be sold, dispensed, or otherwise transferred to any other entity.
Medication donated under the program must be physically segregated from the pharmacy's other drug stock for purposes of inventory, accounting, and inspection.
The pharmacy must keep complete records of the acquisition and disposition of medications donated to and dispensed under the program. These records must be kept separate from its other acquisition and disposition records and be readily retrievable.
Drug manufacturers, wholesalers, governmental entities, county-owned or county-contracted licensed pharmacies, or nursing homes are not subject to criminal or civil liability for injury caused when donating, accepting, or dispensing prescription drugs in compliance with the law. The immunity does not apply in cases of noncompliance with the law, bad faith, or gross negligence.