SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Steven Glazer, Chair

2019 - 2020 Regular

Bill No: SB 476 Hearing Date: April 22, 2019

Author:	Stone
Version:	April 22, 2019
Urgency:	No	Fiscal:	Yes
Consultant:	Sarah Mason

Subject: Pharmacist-in-charge: disciplinary proceedings

SUMMARY: Authorizes the Board of Pharmacy (Board) to issue a fine of up to $50,000 to a person (with 10 percent or more ownership interest in the pharmacy or person with management or control of a licensee) for usurping a pharmacist-in-charge’s (PIC) authority or otherwise hindering a PIC’s ability to carry out their duties.

Existing law:

Establishes the Board within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) § 4001)
Requires every pharmacy to designate a PIC (a pharmacist proposed by a pharmacy and approved by the Board as the supervisor or manager) who is responsible for the pharmacy’s compliance with all state and federal laws.
(BPC §§ 4036.5 and 4113)
States that a PIC shall not be criminally responsible for acts of a pharmacy owner, officer, partner, or employee that constitute a violation of Pharmacy Law if the PIC did not have knowledge or did not knowingly participate in the acts. (BPC 4081 (c))
Authorizes the Board to take disciplinary action against a person who owns
10 percent or more of a licensed pharmacy if the individual engaged in acts that would constitute grounds for disciplinary action against a licenses. (BPC § 4302)

Authorizes the Board, if a PIC is disciplined for a violation committed by another person, and the PIC reported that violation to the Board, to use the report as a mitigating factor if certain conditions are met. (BPC § 4306.6)

This bill authorizes the Board to issue a fine of up to $50,000 to a person (with 10 percent or more ownership interest in the pharmacy or person with management or control of a licensee) for usurping a PIC’s authority or otherwise hindering a PIC’s ability to carry out their duties.

FISCAL EFFECT:

Unknown. This bill is keyed fiscal by Legislative Counsel.

COMMENTS:

Purpose. The Author is the Sponsor of this bill. According to the Author, the Board has the ability to discipline a PIC for violations they commit but also for violations committed by others and the only way for a PIC to avoid discipline is to meet all specified conditions. The Author states that a PIC may sometimes be found in violation of the law “because of something that was not in their authority”, or something they were instructed to do by a pharmacy owner. According to the Author, this bill places responsibility on a license holder/owner of the pharmacy for usurping a PIC’s authority and thus hindering the PIC from carrying out their duties.
Background. Every pharmacy must have a PIC, an individual licensed by the

Board who is specially designated to oversee pharmacy operations. Each pharmacy reports the name of the PIC, and the PIC’s name is printed on the pharmacy's license. California Code of Regulations, title 16, section 10709.1 provides in part, “(a) The pharmacist-in-charge of a pharmacy shall be employed at that location and shall have responsibility for the daily operation of the pharmacy.” The Board believes, as noted in its Disciplinary Guidelines, “When a pharmacist takes on the responsibility of a [PIC], the pharmacist also ensures the pharmacy’s compliance with state and federal law, quality assurance responsibilities, and inventory controls.

The Board’s enforcement activities are the core of its program, with the majority of its staff and resources dedicated to enforcement functions. The Board aims to prevent events that could result in patient harm and ensure that there are consequences to deter events from occurring in other pharmacies. According to the Board, its greatest tool in performing the broad range of investigations and inspections required to regulate such a diverse licensing population are licensed pharmacist inspectors. These investigators work from home offices throughout the state and perform random, unannounced inspections to detect violations, investigate complaints, monitor licensees on probation, educate licensees about Pharmacy Law requirements, serve as expert witnesses in disciplinary hearings and identify violations and issues that non-pharmacists may not be able to identify.

Among the enforcement tools used by the Board following an investigation are the issuance of a citation, citation and fine, or letter of admonishment. These actions are pursued when the violations are not serious enough to warrant referral to the Office of the Attorney General or formal discipline. Citations and fines are used as a means to educate the licensee about Pharmacy Law, ensure compliance, and to note that a violation has occurred. Letters of admonishment are lesser penalties issued by the Board to acknowledge a minor violation that does not warrant issuance of a citation and fine or referral for disciplinary action.

The Board is authorized through regulation to issue citations of up to $5,000 for violations of Pharmacy Law and regulations. The Board reports that for most violations, fines are capped at $5,000 to each licensee investigated in a specific investigation. For example the Board could issue fines of up to $5,000 to a pharmacy, pharmacist, and PIC involved in the same violations of Pharmacy Law discovered through an investigation. If the violation involves multiple licensees, the relative degree of culpability of each licensee is considered. The Board recognizes there may be situations where an individual licensee deserves a stronger penalty than the pharmacy for which he or she works. Similarly, the Board recognizes that in some cases, a licensed premises may well be more culpable than any individual licensed by or registered with the Board. Typically, the Board also believes in holding a pharmacy owner, manager, and/or PIC responsible for the acts of pharmacy personnel. The Board has specific statutory authority to issue higher fines for specific violations, including up to $25,000 per prescription for internet sales of drugs where no underlying appropriate examination occurred.

The Board has the final authority over the disposition of disciplinary cases, for which it consults its Disciplinary Guidelines in reaching a decision. The Board notes that these Guidelines are used by board staff, board members, deputy attorneys general, administrative law judges, and attorneys to set penalties in disciplinary cases for various categories of violations. The Board states that its guidelines also ensure that consistent penalty language is incorporated, and that appropriate terms and conditions of probation are included in all decisions.

SUPPORT AND OPPOSITION:

Support:

None on file as of April 17, 2019.

Opposition:

None on file as of April 17, 2019.

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SB 476: Pharmacy: Pharmacist Employer Advisory Task Force.

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