Bill Text: AZ HB2824 | 2020 | Fifty-fourth Legislature 2nd Regular | Engrossed
Bill Title: Pharmacy board; nonprescription drugs; diversion
Spectrum: Partisan Bill (Republican 1-0)
Status: (Engrossed - Dead) 2020-03-03 - Senate read second time [HB2824 Detail]
Download: Arizona-2020-HB2824-Engrossed.html
|
House Engrossed |
|
State of Arizona House of Representatives Fifty-fourth Legislature Second Regular Session 2020
|
|
HOUSE BILL 2824 |
|
|
|
|
AN ACT
amending section 32‑1904, Arizona Revised Statutes, as amended by laws 2019, chapter 257, section 1; repealing section 32-1904, Arizona Revised Statutes, as amended by laws 2019, chapter 320, section 1; amending sections 32‑1921, 32‑3208, 32‑3214, 32‑3224 and 32‑4801, Arizona Revised Statutes; relating to the Arizona state board of pharmacy.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Section 32-1904, Arizona Revised Statutes, as amended by Laws 2019, chapter 257, section 1, is amended to read:
32-1904. Powers and duties of board; immunity
A. The board shall:
1. Make bylaws and adopt rules that are necessary to protect the public and that pertain to the practice of pharmacy, the manufacturing, wholesaling or supplying of drugs, devices, poisons or hazardous substances, the use of pharmacy technicians and support personnel and the lawful performance of its duties.
2. Fix standards and requirements to register and reregister pharmacies, except as otherwise specified.
3. Investigate compliance as to the quality, label and labeling of all drugs, devices, poisons or hazardous substances and take action necessary to prevent the sale of these if they do not conform to the standards prescribed in this chapter, the official compendium or the federal act.
4. Enforce its rules. In so doing, the board or its agents have free access, during the hours reported with the board or the posted hours at the facility, to any pharmacy, manufacturer, wholesaler, third‑party logistics provider, nonprescription drug permittee or other establishment in which drugs, devices, poisons or hazardous substances are manufactured, processed, packed or held, or to enter any vehicle being used to transport or hold such drugs, devices, poisons or hazardous substances for the purpose of:
(a) Inspecting the establishment or vehicle to determine whether any provisions of this chapter or the federal act are being violated.
(b) Securing samples or specimens of any drug, device, poison or hazardous substance after paying or offering to pay for the sample.
(c) Detaining or embargoing a drug, device, poison or hazardous substance in accordance with section 32‑1994.
5. Examine and license as pharmacists and pharmacy interns all qualified applicants as provided by this chapter.
6. Require each applicant for an initial license to apply for a fingerprint clearance card pursuant to section 41‑1758.03. If an applicant is issued a valid fingerprint clearance card, the applicant shall submit the valid fingerprint clearance card to the board with the completed application. If an applicant applies for a fingerprint clearance card and is denied, the applicant may request that the board consider the application for licensure notwithstanding the absence of a valid fingerprint clearance card. The board, in its discretion, may approve an application for licensure despite the denial of a valid fingerprint clearance card if the board determines that the applicant's criminal history information on which the denial was based does not alone disqualify the applicant from licensure.
7. Issue duplicates of lost or destroyed permits on the payment of a fee as prescribed by the board.
8. Adopt rules to rehabilitate pharmacists and pharmacy interns as provided by this chapter.
9. At least once every three months, notify pharmacies regulated pursuant to this chapter of any modifications on prescription writing privileges of podiatrists, dentists, doctors of medicine, registered nurse practitioners, osteopathic physicians, veterinarians, physician assistants, optometrists and homeopathic physicians of which it receives notification from the state board of podiatry examiners, state board of dental examiners, Arizona medical board, Arizona state board of nursing, Arizona board of osteopathic examiners in medicine and surgery, Arizona state veterinary medical examining board, Arizona regulatory board of physician assistants, state board of optometry or board of homeopathic and integrated medicine examiners.
10. Charge a permittee a fee, as determined by the board, for an inspection if the permittee requests the inspection.
11. Issue only one active or open license per individual.
12. Allow a licensee to regress to a lower level license on written explanation and review by the board for discussion, determination and possible action.
B. The board may:
1. Employ chemists, compliance officers, clerical help and other employees subject to title 41, chapter 4, article 4 and provide laboratory facilities for the proper conduct of its business.
2. Provide, by educating and informing the licensees and the public, assistance in curtailing abuse in the use of drugs, devices, poisons and hazardous substances.
3. Approve or reject the manner of storage and security of drugs, devices, poisons and hazardous substances.
4. Accept monies and services to assist in enforcing this chapter from other than licensees:
(a) For performing inspections and other board functions.
(b) For the cost of copies of the pharmacy and controlled substances laws, the annual report of the board and other information from the board.
5. Adopt rules for professional conduct appropriate to the establishment and maintenance of a high standard of integrity and dignity in the profession of pharmacy.
6. Grant permission to deviate from a state requirement for modernization of pharmacy practice, experimentation and or technological advances.
7. Adopt rules for the training and practice of pharmacy interns, pharmacy technicians and support personnel.
8. Investigate alleged violations of this chapter, conduct hearings in respect to violations, subpoena witnesses and take such action as it deems necessary to revoke or suspend a license or a permit, place a licensee or permittee on probation or warn a licensee or permittee under this chapter or to bring notice of violations to the county attorney of the county in which a violation took place or to the attorney general.
9. By rule, approve colleges or schools of pharmacy.
10. By rule, approve programs of practical experience, clinical programs, internship training programs, programs of remedial academic work and preliminary equivalency examinations as provided by this chapter.
11. Assist in the continuing education of pharmacists and pharmacy interns.
12. Issue inactive status licenses as provided by this chapter.
13. Accept monies and services from the federal government or others for educational, research or other purposes pertaining to the enforcement of this chapter.
14. By rule, except from the application of all or any part of this chapter any material, compound, mixture or preparation containing any stimulant or depressant substance included in section 13‑3401, paragraph 6, subdivision (c) or (d) from the definition of dangerous drug if the material, compound, mixture or preparation contains one or more active medicinal ingredients not having a stimulant or depressant effect on the central nervous system, provided that such admixtures are included in such combinations, quantity, proportion or concentration as to vitiate the potential for abuse of the substances that do have a stimulant or depressant effect on the central nervous system.
15. Adopt rules for the revocation, suspension or reinstatement of licenses or permits or the probation of licensees or permittees as provided by this chapter.
16. Issue a certificate of free sale to any person that is licensed by the board as a manufacturer for the purpose of manufacturing or distributing food supplements or dietary supplements as defined in rule by the board and that wants to sell food supplements or dietary supplements domestically or internationally. The application shall contain all of the following:
(a) The applicant's name, address, e-mail email address, telephone and fax number.
(b) The product's full, common or usual name.
(c) A copy of the label for each product listed. If the product is to be exported in bulk and a label is not available, the applicant shall include a certificate of composition.
(d) The country of export, if applicable.
(e) The number of certificates of free sale requested.
17. Establish an inspection process to issue certificates of free sale or good manufacturing practice certifications. The board shall establish in rule:
(a) A fee to issue certificates of free sale.
(b) A fee to issue good manufacturing practice certifications.
(c) An annual inspection fee.
18. Delegate to the executive director the authority to:
(a) Void a license or permit application and deem all fees forfeited by the applicant if the applicant provided inaccurate information on the application. Except for inaccurate information provided regarding education or criminal history, The applicant shall have the opportunity to correct the inaccurate information within thirty days after the initial application was voided. If the applicant provides inaccurate information regarding education or criminal history and the application is voided, the applicant may submit a new application with all associated fees reviewed by board staff and the applicant was informed of the inaccuracy.
(b) If the president or vice president of the board concurs after reviewing the case, enter into an interim consent agreement with a licensee or permittee if there is evidence that a restriction against the license or permit is needed to mitigate danger to the public health and safety. The board shall may subsequently formally adopt the interim consent agreement with any modifications the board deems necessary for the agreement to be fully enforceable.
(c) Take no action or dismiss a complaint that has insufficient evidence that a violation of statute or rule governing the practice of pharmacy occurred.
(d) Request an applicant or licensee to provide court documents and police reports if the applicant or licensee has been charged with or convicted of a criminal offense. The executive director may do either of the following if the applicant or licensee fails to provide the requested documents to the board within fourteen thirty business days after the request:
(i) Close the application, deem the application fee forfeited and not consider a new application complete unless the requested documents are submitted with the application.
(ii) Suspend the licensee and open a complaint for unprofessional conduct.
(ii) Notify the licensee of an opportunity for a hearing in accordance with section 41‑1061 to consider suspension of the licensee.
(e) Pursuant to section 36‑2604, subsection B, review prescription information collected pursuant to title 36, chapter 28, article 1.
C. At each regularly scheduled board meeting, the executive director shall provide to the board a list of the executive director's actions taken pursuant to subsection B, paragraph 18, subdivisions (a), (c) and (d) of this section since the last board meeting.
D. The board shall develop substantive policy statements pursuant to section 41‑1091 for each specific licensing and regulatory authority the board delegates to the executive director.
D. E. The executive director and other personnel or agents of the board are not subject to civil liability for any act done or proceeding undertaken or performed in good faith and in furtherance of the purposes of this chapter.
Sec. 2. Repeal
Section 32-1904, Arizona Revised Statutes, as amended by Laws 2019, chapter 320, section 1, is repealed.
Sec. 3. Section 32-1921, Arizona Revised Statutes, is amended to read:
32-1921. Exempted acts; exemption from registration fees; definition
A. This chapter does not prevent:
1. The prescription and dispensing of drugs or prescription medications by a registered nurse practitioner or clinical nurse specialist pursuant to rules adopted by the Arizona state board of nursing in consultation with the Arizona medical board, the Arizona board of osteopathic examiners in medicine and surgery and the Arizona state board of pharmacy.
2. The sale of nonprescription drugs that are sold at retail in original packages by a person holding a permit issued by the board under this chapter. This chapter does not require a person to hold a board‑issued permit to sell only nonprescription drugs at retail in original packages.
3. The sale of drugs at wholesale by a wholesaler or manufacturer that holds the required permit issued by the board to a person who holds the required permit issued under this chapter.
4. The manufacturing of drugs by a person who is not a pharmacist and who holds the required permit issued by the board under this chapter.
5. The following health professionals from dispensing or personally administering drugs or devices to a patient for a condition being treated by the health professional:
(a) A doctor of medicine licensed pursuant to chapter 13 of this title.
(b) An osteopathic physician licensed pursuant to chapter 17 of this title.
(c) A homeopathic physician licensed pursuant to chapter 29 of this title.
(d) A podiatrist licensed pursuant to chapter 7 of this title.
(e) A dentist licensed pursuant to chapter 11 of this title.
(f) A doctor of naturopathic medicine who is authorized to prescribe natural substances, drugs or devices and who is licensed pursuant to chapter 14 of this title.
(g) An optometrist who is licensed pursuant to chapter 16 of this title and who is certified for topical or oral pharmaceutical agents.
6. A veterinarian licensed pursuant to chapter 21 of this title from dispensing or administering drugs to an animal or from dispensing or administering devices to an animal being treated by the veterinarian.
7. The use of any pesticide chemical, soil or plant nutrient or other agricultural chemical that is a color additive solely because of its effect in aiding, retarding or otherwise affecting directly or indirectly the growth or other natural physiological process of produce of the soil and thereby affecting its color whether before or after harvest.
8. A licensed practical or registered nurse employed by a person licensed pursuant to chapter 7, 11, 13, 14, 17 or 29 of this title from assisting in the delivery of drugs and devices to patients, in accordance with chapter 7, 11, 13, 14, 17 or 29 of this title.
9. The use of any mechanical device or vending machine in connection with the sale of any nonprescription drug, including proprietary and patent medicine. The board may adopt rules to prescribe conditions under which nonprescription drugs may be dispensed pursuant to this paragraph.
B. A person who is licensed pursuant to chapter 7, 11, 13, 14, 17 or 29 of this title and who employs a licensed practical or registered nurse who in the course of employment assists in the delivery of drugs and devices is responsible for the dispensing process.
C. Pursuant to a prescription order written by a physician for the physician's patients and dispensed by a licensed pharmacist, a physical therapist licensed pursuant to chapter 19 of this title, an occupational therapist licensed pursuant to chapter 34 of this title or an athletic trainer licensed pursuant to chapter 41 of this title may procure, store and administer nonscheduled legend and topical anti‑inflammatories and topical anesthetics for use in phonophoresis and iontophoresis procedures and within the scope of practice of physical or occupational therapy or athletic training.
D. A public health facility operated by this state or a county and a qualifying community health center may dispense medication or devices to patients at no cost without providing a written prescription if the public health facility or the qualifying community health center meets all storage, labeling, safety and record keeping rules adopted by the board of pharmacy.
E. A person who is licensed pursuant to chapter 7, 11, 13, 14, 17 or 29 of this title, who is practicing at a public health facility or a qualifying community health center and who is involved in the dispensing of medication or devices only at a facility or center, whether for a charge or at no cost, shall register to dispense with the appropriate licensing board but is exempt from paying registration fees.
F. For the purposes of this section, "qualifying community health center" means a primary care clinic that is recognized as nonprofit under section 501(c)(3) of the United States internal revenue code and whose board of directors includes patients of the center and residents of the center's service area.
Sec. 4. Section 32-3208, Arizona Revised Statutes, is amended to read:
32-3208. Criminal charges; mandatory reporting requirements; civil penalty; exceptions
A. A health professional who has been charged with a misdemeanor involving conduct that may affect patient safety or a felony after receiving or renewing a license or certificate must notify the health professional's regulatory board in writing within ten working days after the charge is filed.
B. An applicant for licensure or certification as a health professional who has been charged with a misdemeanor involving conduct that may affect patient safety or a felony after submitting the application must notify the regulatory board in writing within ten working days after the charge is filed.
C. On receipt of this information the regulatory board may conduct an investigation.
D. A health professional who does not comply with the notification requirements of this section commits an act of unprofessional conduct. The health professional's regulatory board may impose a civil penalty of not more than one thousand dollars $1,000 in addition to other disciplinary action it takes.
E. The regulatory board may deny the application of an applicant who does not comply with the notification requirements of this section.
F. On request, a health profession regulatory board shall provide an applicant or health professional with a list of misdemeanors that the applicant or health professional must report.
G. Notwithstanding any other provision of this section, a person who is licensed or permitted pursuant to chapter 18 of this title is not subject to:
1. An investigation, a civil penalty or any other disciplinary action for failing to disclose a criminal charge if the criminal charge is more than four years old and does not involve sexual misconduct, an incident or occurrence involving a felony, diversion of a controlled substance or impairment while practicing. Diversion of a controlled substance does not include administrative errors or recordkeeping violations when there is not evidence of an actual loss of a controlled substance.
2. A civil penalty or any other disciplinary action for failing to report a criminal charge if the licensee or permittee has disclosed the charge in any manner, including a renewal application, even if the disclosure occurred after the ten-working-day period specified in subsection A of this section.
Sec. 5. Section 32-3214, Arizona Revised Statutes, is amended to read:
32-3214. Board actions; public access to records; website
A. If a health profession regulatory board dismisses a complaint, the record of that complaint is available to that regulatory board and the public pursuant to section 39‑121 but may not appear on the board's website. For the purposes of this subsection, "dismisses a complaint" means that a board does not issue a disciplinary or nondisciplinary order or action against a licensee or certificate holder. A pending complaint or investigation may not be disclosed to the public.
B. All disciplinary actions against a licensee or certificate holder shall be available on the health profession regulatory board's website for not more than five years. After January 1, 2018, If a health profession regulatory board issues a final nondisciplinary order or action, the record of the final nondisciplinary order or action shall be made available on the board's website for not more than five years. Letters of concern and advisory letters may not be made available on the website but a copy of such letters are available to the public pursuant to section 39‑121 and shall be provided to any person on request.
C. If a health profession regulatory board maintains a website, the board must display on its website a statement that a person may obtain additional public records related to any licensee or certificate holder, including dismissed complaints and nondisciplinary actions and orders, by contacting the board directly.
D. This section does not prohibit a health profession regulatory board from conducting its authorized duties in a public meeting.
E. Subsections A and B of this section do not apply to meeting minutes and notices kept by the board in accordance with the public meeting requirements of title 38, chapter 3, article 3.1.
F. A health profession regulatory board must comply with the requirements of this section on or before January 1, 2018.
Sec. 6. Section 32-3224, Arizona Revised Statutes, is amended to read:
32-3224. Complaints; time limit on filing; exceptions
A. Notwithstanding any time limitation limit to the contrary in this title, a health profession regulatory board may not act on its own motion or on any complaint received by the board in which an allegation of unprofessional conduct or any other violation of the chapter that applies to a professional who holds an Arizona license or certificate occurred more than four years before the complaint is received by the board. This time limitation limit does not apply to:
1. Medical malpractice settlements or judgments, or allegations of sexual misconduct or if such an incident or occurrence that involved a felony, diversion of a controlled substance or impairment while practicing by the licensee or certificate holder.
2. A The board's consideration of the specific unprofessional conduct related to a the licensee's or certificate holder's failure to disclose conduct or a violation as required by law. This paragraph does not apply to a person who is licensed or permitted pursuant to chapter 18 of this title unless the conduct or violation is related to sexual misconduct, an incident or occurrence involving a felony, diversion of a controlled substance or impairment while practicing.
B. Diversion of a controlled substance does not include administrative errors or recordkeeping violations when there is not evidence of an actual loss of a controlled substance.
Sec. 7. Section 32-4801, Arizona Revised Statutes, is amended to read:
32-4801. Public meetings; digital recordings; posting; definition
A. Each licensing authority shall:
1. In addition to the requirements prescribed in title 38, chapter 3, article 3.1, provide for a digital recording of each licensing authority meeting, except for executive sessions.
2. Post on its website the digital recording of the meeting not later than five days after the meeting and retain the recording on its website for at least three years.
3. Except as prescribed by sections 32‑3214 and 41‑1092.09, post on its website all final decisions, orders and actions the licensing authority takes not later than five days after the meeting and retain this information on its website for at least three years but not more than five years.
B. For the purposes of this section, "licensing authority" has the same meaning prescribed in section 32‑4701.
