This year, the California State Board of Pharmacy (“Board”) adopted a new regulation applicable to pharmacies where pharmacists perform non-professional activities because they work alone. The regulation – Title 16, California Code of Regulations, Section 1714 – establishes criteria a pharmacy must meet to identify and ensure that a person is assigned to assist the pharmacist when the pharmacist is otherwise working alone, as required by Business and Professions Code Section 4113.5.

Prior to the enactment of Section 4113.5, pharmacists were often working alone for extended periods of time. This resulted in the pharmacist having to perform non-pharmacist related functions, including staffing the cash register and assisting customers with non-pharmacy purchases. According to the Board, performing these duties takes time away from the pharmacist’s professional responsibilities and could impact public health as the pharmacist has insufficient time to safely exercise their professional judgement while reviewing and filling prescriptions. Additionally, it impacts the pharmacist’s ability to provide appropriate patient centered care.

Therefore, Section 4113.5 was enacted to prohibit a community pharmacy from “requiring a pharmacist to engage in the practice of pharmacy while the pharmacy is open to the public unless another employee of the pharmacy or the establishment is always made available to assist the pharmacist.” The section also specifies that the prohibition shall not apply to pharmacies that meet specific criteria, including, but not limited to, a hospital pharmacy (as defined by Section 4029 or 4056), a hospital outpatient pharmacy, “a pharmacy owned by a person or persons who, collectively, control the majority of the beneficial interest in no more than four pharmacies in California,” or a government owned pharmacy.

Section 1714.3, in turn, was enacted to identify the criteria that the pharmacy must meet to comply with Sec. 4113.5.

Sec. 1714.3 now requires the following:

• the pharmacy must identify one or more persons who will be available to assist the pharmacist;
• the backup person must be able to perform the duties of non-licensed pharmacy personnel
• the pharmacy should run background checks for each backup person (this designated person should be qualified to have access to controlled substances)
• the designated person must respond and be able to assist the pharmacist within five minutes (!) after the pharmacist’s request.
• the pharmacy must have policies and procedures addressing how a designated person is identified, trained, and contacted.

If your pharmacy has a pharmacist working alone (and you are not exempt as provided by Section 4113.5), you must comply with both sections (Sec. 1414.3 and Sec. 1714.3) If you need assistance with drafting policies and procedures as required by these regulations, feel free to contact RxPolicy.