California Passes AB 1442, which Defines “Pharmaceutical Waste” and Authorizes its Transportation by Generators or Common Carriers under Certain Conditions

A pharmaceutical waste hauling bill, AB 1442 (Wieckowski), was chaptered into law on September 29, 2012 and went into effect on January 1, 2013. AB 1442 amends California’s Medical Waste Management Act (MWMA),[1] to define “pharmaceutical waste” and permit its transportation by generators or common carriers, provided that certain requirements are met.

Prior to AB 1442, the MWMA required that all medical waste be hauled by a registered hazardous waste handler, unless the hauler obtained an approved limited-quantity exemption. Pharmaceutical drugs could be hauled by common carrier, but pharmaceuticals designated as waste (such as expired drugs) were classified as medical waste and required to be shipped as hazardous waste. AB 1442 changes existing law to allow, if specific requirements are met, the transport of pharmaceutical waste through self-transport or common carrier in certain situations where: (1) unwanted pharmaceuticals are sent into reverse distribution, or (2) generators of pharmaceutical waste transport it for consolidation prior to treatment and disposal.

AB 1442 defines “pharmaceutical waste” as any “pharmaceutical” that is “waste,” as those terms are defined in pre-existing provisions of the MWMA.[2] The pre-existing definition of “pharmaceutical” includes prescription and over-the-counter drugs, but exempts all drugs that fall within the definition of hazardous waste by the Resource Conservation and Recovery Act (RCRA) or the California Radiation Control Law (RCL) (these statutes have their own transportation requirements for qualifying pharmaceuticals). Whether or not particular pharmaceutical waste is classified as a RCRA or RCL hazardous waste depends on a number of factors, such as ignitability, corrosivity, reactivity, and toxicity. AB 1442 does not modify the transportation requirements for pharmaceuticals that are regulated by RCRA or the RCL.

AB 1442 exempts unwanted pharmaceuticals from the definition of “pharmaceutical waste” if they are being sent to a properly-licensed reverse distributor.[3] Accordingly, unwanted pharmaceuticals now may be sent into reverse distribution by self-transport or common carrier. One caveat is that if the unwanted pharmaceuticals are sent to a reverse distributor located within California, the reverse distributor must be a permitted medical waste transfer station. Reverse distribution is the practice of pharmaceutical dispensers returning pharmaceuticals to their manufacturer, or an agent of their manufacturer. Under California law, a reverse distributor is defined as every person who acts as an agent for pharmacies, drug wholesalers, manufacturers, and other entities by receiving, inventorying, and managing the disposition of outdated or unsalable drugs.[4] The drugs may be unwanted and returned for various reasons, such as oversupply, expiration, recall, shipping error, or damage.

AB 1442 also allows pharmaceutical waste that is being transported for consolidation before treatment and disposal to be self-transported or transported by common carrier where specific requirements are met. Where the requirements are met, the generator of pharmaceutical waste may self-transport it to “a parent organization or another health care facility for the purpose of consolidation before treatment and disposal.” Or, if the requirements are met, the generator may contract with a common carrier “to transport the pharmaceutical waste to a permitted medical waste treatment facility or transfer station.”[5] The requirements for the “consolidation” classification include, but are not limited to, providing notices and confirmations among the transporting entities and reporting discrepancies to enforcement agencies. Generators are also required to be properly registered and/or have prepared medical waste management plans pursuant to various statutes depending on the status of the generator.

Advocates of the bill, including the City of San Jose and the County of Alameda, recommended passage of AB 1442, claiming the bill will make it more likely that pharmaceutical waste will be disposed of properly because use of self-transport or common carriers in reverse distribution will reduce the cost to recover the pharmaceutical waste.

[1] Cal. Health & Safety (“H&S”) Code §§ 117600 – 118360.

[2] H&S Code § 117748(a), referencing H&S Code §§ 25124 and 117747.

[3] H&S Code § 117748(b), referencing Cal. Bus. & Prof. Code §§ 4040.5, 4160 and 4161.

[4] H&S Code § 4040.5

[5] H&S Code § 118032.