USP <800>, and Pending California Board of Pharmacy Hazardous Drug Regulations
Updated: September 2016
We are providing this updated notice as part of CPhA’s continued efforts to clarify the pending California Board of Pharmacy Compounding and Hazardous Drugs Regulations. Please note the new information highlighted below.
As many pharmacists are aware, the California Board of Pharmacy (BOP) has been working on updated compounding regulations for several years. CPhA, through its Academy of Compounding Pharmacists, has been heavily involved in advocating for compounding pharmacists throughout this regulatory process, which has resulted in a number of positive changes to the proposed regulations. The goal of the BOP is to create regulations intended to protect consumers through greater detail and increased consistency with USP Chapter <797>. CPhA is ensuring that this goal can be met while protecting a pharmacy’s ability to compound where appropriate.
In addition to establishing various requirements for sterile compounding, the proposed regulations establish some standards for the compounding of hazardous drugs. CPhA is aware that there is some confusion regarding whether the BOP will enforce the entirety of USP Chapter <800> relating to handling of hazardous drugs in a healthcare settings, or whether the proposed regulations adopt USP <800> into state law. This question has been particularly concerning for compounding pharmacies because the proposed BOP regulations have an effective date of January 1, 2017. As explained in further detail below, pharmacies compounding hazardous drugs will not be required to comply with the USP <800> provisions on January 1, 2017. However, all compounding pharmacies will be required to comply with the pending general regulatory updates in 16 CCR 1735 and 16 CCR 1751 on January 1, 2017. The California compounding regulations have since been finalized, and can be found here: http://www.pharmacy.ca.gov/laws_regs/1735_ooa_clean.pdf.
Since 2014, USP has been finalizing revisions to the entirety of Chapter <800>. The revised chapter generally holds that there is no acceptable level of exposure to hazardous drugs, and this zero tolerance must be achieved by compounding pharmacies through the use of engineering controls, personal protective equipment, and proper handling technique. The standards are stringent enough that pharmacies may need physical upgrades to their facilities and/or engineering controls.
The proposed California BOP regulations adopt certain requirements for engineering controls consistent with USP <800>, but the regulations do not adopt USP<800> in its entirety. Specifically, the new regulations only apply to antineoplastic agents identified by NIOSH as hazardous. It is important to note that this does not include non-antineoplastic ingredients used in compounding (e.g., progesterone, testosterone, estrogen, phenytoin, finasteride, fluconazole, oxytocin, etc.).
Specifically, the new regulations only apply to antineoplastic agents identified by NIOSH as hazardous and/or those materials identified as hazardous by the pharmacist-in-charge. It is important to note that this does not include non-antineoplastic ingredients (e.g., progesterone, testosterone, estrogen, phenytoin, finasteride, fluconazole, oxytocin, etc.) except to the extent that the PIC determines through their professional judgement those materials are hazardous. During the August 31, 2016 Board of Pharmacy meeting, Supervising Inspector with the BOP, Christine Acosta, clarified that not all hormones should be considered hazardous, but further stated that it will depend on individual circumstances and whether a pharmacist can justify that such compounded hormones are not determined to be hazardous. If the pharmacy utilizes proper equipment (powder containment hood) and PPEs (gloves, gowns, etc.) and determines that their processes ensure there are no health hazards, then the non-antineoplastic ingredients are not deemed hazardous and you will not have to comply with the hazardous drug sections of the regulations effective January 1, 2017.
Despite this clarification, CPhA understands that there is still some confusion among pharmacists in how to identify which ingredients are hazardous or not. We encourage compounders to contact the BOP’s “Ask the Inspector” hotline at 916-574-7900 or email@example.com for any compliance or specific hazardous drug questions.
In addition, all hazardous compounding, of antineoplastic agents identified by NIOSH as hazardous, must be completed in an externally ventilated, physically separate room in compliance with all of the following requirements:
- Minimum of 30 air changes per hour except that 12 air changes per hour are acceptable for segregated compounding areas with a BSC or CACI when products are assigned a BUD of 12 hours or less or when non sterile products are compounded;
- Maintained at a negative pressure of 0.01 to 0.03 inches of water column relative to all adjacent spaces (rooms, above ceiling, and corridors);
- Each PEC in the room shall also be externally vented; and
- All surfaces within the room shall be smooth, seamless, impervious, and non-shedding.
The BOP regulations have a proposed effective date of January 1, 2017, but at CPhA’s insistence, the BOP included a process for pharmacies to apply for a waiver from the above requirements when compliance requires physical construction or alteration and the pharmacy needs additional time beyond the implementation date to complete the upgrades. The BOP will require that good cause be demonstrated and it is recommended that pharmacies compounding antineoplastic agents, identified by NIOSH as hazardous, or any other hazardous non-antineoplastic ingredients, should develop a plan and begin implementing steps necessary to comply with the above BOP requirements.
At the August 31st BOP meeting, Executive Officer, Virginia Herold, presented the Board’s proposal for how the waiver application would work. Although the waiver has not been officially approved yet, the Board proposed that pharmacists in good faith trying to comply with the new construction requirements will need to:
- Provide a written reason for why the waiver is needed.
- Write a description on the status of the construction process that is in place for the pharmacy (i.e. vetting and contracting, acquiring city and county permits, purchase of facility elements).
- If review by OSHPD is required, provide a copy of the Project Completion Timeline and the General OSHPD project number.
- Provide a written description of how the pharmacy will perform compounding while the construction waiver is in effect.
CPhA will send additional communications to members when the waiver application process is finalized by the Board. In addition, CPhA is working on providing members a step by step toolkit to guide you through the waiver application requirements.
CPhA will continue to represent pharmacists in the process and will keep members updated of any new developments. Please watch for future e-communications from CPhA on this matter.