California

Health and Safety Code – HSC § 118032

A pharmaceutical waste generator or parent organization that employs health care professionals who generate pharmaceutical waste is exempt from the requirements of subdivision (a) of Section 118000 if all of the following requirements are met:

(a) The generator or parent organization has on file one of the following:

(1) If the generator or parent organization is a small quantity generator required to register pursuant to Chapter 4 (commencing with Section 117925 ), a medical waste management plan prepared pursuant to Section 117935 .

(2) If the generator or parent organization is a small quantity generator not required to register pursuant to Chapter 4 (commencing with Section 117925 ), the information document maintained pursuant to subdivision (a) of Section 117945 .

(3) If the generator or parent organization is a large quantity generator, a medical waste management plan prepared pursuant to Section 117960 .

(b) The generator or health care professional who generated the pharmaceutical waste transports the pharmaceutical waste himself or herself, or directs a member of his or her staff to transport the pharmaceutical waste to a parent organization or another health care facility for the purpose of consolidation before treatment and disposal, or contracts with a common carrier to transport the pharmaceutical waste to a permitted medical waste treatment facility or transfer station.

(c) Except as provided in subdivision (d), all of the following requirements are met:

(1) Prior to shipment of the pharmaceutical waste, the generator notifies the intended destination facility that it is shipping pharmaceutical waste to it and provides a copy of the tracking document, as specified in Section 118040 .

(2) The generator and the facility receiving the pharmaceutical waste maintain the tracking document, as specified in Section 118040 .

(3) The facility receiving the pharmaceutical waste notifies the generator of the receipt of the pharmaceutical waste shipment and any discrepancies between the items received and the tracking document, as specified in Section 118040 , evidencing diversion of the pharmaceutical waste.

(4) The generator notifies the enforcement agency of any discrepancies between the items received and the tracking document, as specified in Section 118040 , evidencing diversion of the pharmaceutical waste.

(d)(1) Notwithstanding subdivision (c), if a health care professional who generates pharmaceutical waste returns the pharmaceutical waste to the parent organization for the purpose of consolidation before treatment and disposal over a period of time, a single-page form or multiple entry log may be substituted for the tracking document, if the form or log contains all of the following information:

(A) The name of the person transporting the pharmaceutical waste.

(B) The number of containers of pharmaceutical waste.  This clause does not require any generator to maintain a separate pharmaceutical waste container for every patient or to maintain records as to the specified source of the pharmaceutical waste in any container.

(C) The date that the pharmaceutical waste was returned.

(2) The form or log described in paragraph (1) shall be maintained in the files of the health care professional who generates the pharmaceutical waste and the parent organization or another health care facility that receives the pharmaceutical waste.

(3) This subdivision does not prohibit the use of a single document to verify the return of more than one container to a parent organization or another health care facility, provided the form or log meets the requirements specified in paragraphs (1) and (2).




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