Californians for Safe Prescriptions v. California State Board of Pharmacy

19 Cal. App. 4th 1136, 23 Cal. Rptr. 2d 755, 93 Daily Journal DAR 13589, 93 Cal. Daily Op. Serv. 7966, 1993 Cal. App. LEXIS 1068
CourtCalifornia Court of Appeal
DecidedOctober 27, 1993
DocketB073104
StatusPublished
Cited by7 cases

This text of 19 Cal. App. 4th 1136 (Californians for Safe Prescriptions v. California State Board of Pharmacy) is published on Counsel Stack Legal Research, covering California Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Californians for Safe Prescriptions v. California State Board of Pharmacy, 19 Cal. App. 4th 1136, 23 Cal. Rptr. 2d 755, 93 Daily Journal DAR 13589, 93 Cal. Daily Op. Serv. 7966, 1993 Cal. App. LEXIS 1068 (Cal. Ct. App. 1993).

Opinion

Opinion

LILLIE, P. J.

Plaintiff, a nonprofit corporation comprised of pharmacists throughout California, appeals from a judgment denying its petition for writ of mandamus and for injunctive relief wherein plaintiff challenged various *1141 regulations promulgated by defendant California State Board of Pharmacy (Board) pertaining to pharmacy technicians. Plaintiff contends that the regulations are invalid because the Board amended them on June 17, 1992 without a public hearing; it also challenges the validity of several regulations on the ground that they are inconsistent with enabling legislation (Bus. & Prof. Code, § 4008.5), or other statutes, or on the ground that they lack the consistency or clarity required of administrative regulations.

Factual and Procedural Background

In 1991, the Legislature passed Assembly Bill No. 1244, which enacted Business and Professions Code section 4008.5, to authorize the use of pharmacy technicians in the prescription dispensing process. 1 As explained in the Legislative Counsel’s Digest to the bill, “Existing law, with specified *1142 exceptions, makes it unlawful for any person to manufacture, compound, sell, or dispense, as defined, any dangerous drug or devices, or to dispense or compound any prescription of a medical practitioner unless he or she is a registered pharmacist, as defined, [fl] This bill would, with specified exceptions, permit a pharmacy technician, as defined, to perform packaging, manipulative, repetitive, or other nondiscretionary tasks while assisting, and while under the direct supervision of, a registered pharmacist. [1J] The bill would also impose specific requirements on pharmacy technicians, including being registered with, and certified by, the California State Board of Pharmacy, except that these requirements would not apply to persons employed or utilized as pharmacy technicians in the filling of prescriptions for an inpatient of a hospital or for an inmate of a correctional facility. . . . [fl] The bill would also require the board to adopt regulations to implement the provisions of the bill.” (Legis. Counsel’s Digest of Assem. Bill No. 1244 (1991-1992 Reg. Sess.).)

On December 6, 1991, the Board caused to be published notice of public hearing on proposed action adopting sections 1793 to 1793.7 and amending section 1717 of title 16 of the California Code of Regulations (all further references to rules are to this source). A public hearing was held on January 21, 1992, on the Board’s proposed regulations of pharmacy technicians; on January 29, 1992, the Board noticed certain amendments to the regulations in response to comments received in connection with the public hearing; the notice stated that written comments regarding the latest proposed amendments to the regulations must be sent to the Board by February 14, 1992.

On April 17, 1992, the Board submitted the proposed regulations to the Office of Administrative Law (OAL) for review; on June 1, 1992, the OAL disapproved the proposed regulations, and issued on June 5 a detailed decision explaining the reasons for disapproval.

*1143 On June 17, 1992, the Board noticed amendments to the regulations “[i]n response to the clarity and consistency issues cited by the [OAL],” and stated in its notice that written comments regarding the latest proposed amendments to rules 1793 to 1793.7 must be sent to the Board no later than July 3, 1992.

By letter of June 24, 1992, counsel for plaintiff sent to the Board plaintiff’s comments on the proposed regulations and also requested that the latest proposed amendments be subject to public hearing.

The Board rejected the request for another public hearing and submitted the amended regulations to OAL on July 10, 1992; OAL approved them on August 12, 1992; the regulations became effective on September 11, 1992.

On September 17, 1992, plaintiff filed petition for writ of mandamus and complaint for declaratory and injunctive relief. The first cause of action for administrative mandamus sought a writ to command the Board to hold public hearings before implementing the amended regulations; the second cause of action for declaratory relief sought a declaration that certain regulations were invalid for failure to comply with standards of consistency and clarity; a third cause of action for injunctive relief sought to enjoin the implementation of the regulations based on the alleged lack of a public hearing prior to their enactment and on the ground the regulations were inconsistent with legislative intent and lacked clarity.

The Board filed a return and opposition to the petition for writ of mandate. After hearing on November 2, 1992, the court issued a statement of decision wherein it determined that the Board “followed and complied with the provisions of the Administrative Procedure Act (Government Code section 11340 et seq.) and the requirements of the Office of Administrative Law in promulgating and adopting the regulations. [][]... Specifically, [the Board] was not legally compelled to hold a second public hearing after the rejection of the regulations by the Office of Administrative Law and their revision by [the Board.] Pursuant to Government Code sections 11346.8 and 11349.4(a), taken together, such an additional public hearing was only required if there was a substantive change to the regulation which was not so sufficiently related to the original text of the regulation that the public was adequately placed on notice the change could result from the originally proposed regulatory action. Each change to the regulation which petitioner claimed required a new hearing was sufficiently related, within the meaning of Government Code section 11346.8(c). . . . [f| Nothing in the regulations as adopted was inconsistent with the language or intent of Business and Professions Code section 4008.5. ...[]]] The regulations do not lack clarity. . . .”

*1144 The judgment, filed December 15, 1992, denied the petition for writ of mandate, the request for preliminary injunction, and all other relief requested by plaintiff. Plaintiff filed timely notice of appeal from the judgment.

I

No Additional Public Hearing Was Required

Appellant contends that the Board’s June 17, 1992, amendments to the regulations, proposed after the OAL rejected former versions of the regulations on June 1, 1992, required a public hearing before their adoption because they contained significant changes within the meaning of Government Code section 11349.4, subdivision (a).

Government Code section 11349.4 provides in pertinent part: “(a) A regulation returned to an agency because of failure to meet the standards of Section 11349.1, because of an agency’s failure to comply with this chapter may be rewritten and resubmitted within 120 days of the agency’s receipt of the written opinion . . . without complying with the notice and public hearing requirements of Sections 11346.4, 11346.5, and 11346.8 unless the substantive provisions of the regulation have been significantly changed. If the regulation has been significantly changed ...

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19 Cal. App. 4th 1136, 23 Cal. Rptr. 2d 755, 93 Daily Journal DAR 13589, 93 Cal. Daily Op. Serv. 7966, 1993 Cal. App. LEXIS 1068, Counsel Stack Legal Research, https://law.counselstack.com/opinion/californians-for-safe-prescriptions-v-california-state-board-of-pharmacy-calctapp-1993.