Bill Text: AZ HB2730 | 2012 | Fiftieth Legislature 2nd Regular | Introduced
Bill Title: Prescriptions; foreign pharmacies
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2012-02-02 - Referred to House HHS Committee [HB2730 Detail]
Download: Arizona-2012-HB2730-Introduced.html
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REFERENCE TITLE: prescriptions; foreign pharmacies |
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State of Arizona House of Representatives Fiftieth Legislature Second Regular Session 2012
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HB 2730 |
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Introduced by Representative Crandell
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AN ACT
Amending section 32-1907, Arizona Revised Statutes; amending title 32, chapter 18, Arizona Revised Statutes, by adding article 5; relating to imported prescription medication.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Section 32-1907, Arizona Revised Statutes, is amended to read:
32-1907. Arizona state board of pharmacy fund
A. Except as provided in section 32‑1939, the executive director shall receive and receipt for all fees and other monies provided for in this chapter and shall deposit, pursuant to sections 35‑146 and 35‑147, ten per cent of such monies in the state general fund and ninety per cent in the Arizona state board of pharmacy fund. All monies derived from civil penalties collected pursuant to this chapter shall be deposited, pursuant to sections 35‑146 and 35‑147, in the general fund.
B. Except as provided in subsection subsections C and D of this section, monies deposited in the Arizona state board of pharmacy fund shall be are subject to section 35‑143.01.
C. From monies deposited in the Arizona state board of pharmacy fund pursuant to subsection A of this section, the executive director may transfer up to three hundred ninety-five thousand seven hundred ninety-five dollars annually to the controlled substances prescription monitoring program fund established by section 36‑2605 for expenses related to the controlled substances prescription monitoring program as required by title 36, chapter 28.
D. The board shall establish a separate account in the fund for monies transferred to the fund pursuant to article 5 of this chapter. The board shall use monies in the account for costs associated with the administration of the office of pharmaceutical importation.
Sec. 2. Title 32, chapter 18, Arizona Revised Statutes, is amended by adding article 5, to read:
ARTICLE 5. IMPORTED PRESCRIPTION MEDICATION
32-1999.01. Definitions
In this article, unless the context otherwise requires:
1. "Approved foreign pharmacy" means a pharmacy that is approved by the office to import prescription medication to this state pursuant to this article and that is a member of the European Union or is located in Australia, Canada, Japan, New Zealand, Singapore, Turkey or any other country approved by the office.
2. "Good manufacturing practices" means those practices that a country requires in the manufacturing of pharmaceuticals to ensure quality control.
3. "Office" means the office of pharmaceutical importation.
4. "Website director" means a doctor who is licensed pursuant to chapter 13 or 17 of this title or a pharmacist who is licensed pursuant to this chapter and who is responsible for facilitating the transfer of prescription medication between an approved foreign pharmacy and the prescribing doctor in this state by maintaining a website pursuant to this article.
32-1999.02. Office of pharmaceutical importation; duties
A. The office of pharmaceutical importation is established in the Arizona state board of pharmacy to facilitate the safe importation of prescription medication from approved foreign pharmacies for personal use to residents of this state who have a prescription order issued by a doctor who is licensed pursuant to this title.
B. The office shall:
1. Register website directors and establish a registry of website directors.
2. Establish a registry of approved foreign pharmacies.
3. Establish standards for approving foreign pharmacies. The standards adopted by the office may be based on standards adopted by the national association of boards of pharmacy or another association or organization that provides standards for certifying internet or foreign pharmacies.
4. Establish a website that provides:
(a) Information regarding the office's purpose, operation and contact information.
(b) The name and contact information of each registered website director.
(c) A list of each approved foreign pharmacy.
5. Assign an independent agency to annually inspect each approved foreign pharmacy for compliance with the requirements of this article and to inspect common prescription medications to ensure compliance with the quality control requirements prescribed by the United States food and drug administration. The approved foreign pharmacy shall pay for the costs of each inspection as a condition of continued approval.
6. Establish a list of approved foreign pharmacy websites.
7. Establish a list of prescription medications that are approved for importation.
C. Before registering a pharmacy as an approved foreign pharmacy pursuant to this article, the office shall consider:
1. The qualifications and credentials of the applicant.
2. Any suspension or revocation of a license or restriction on a license held by the applicant.
32-1999.03. Approved foreign pharmacies; requirements; fees
A. An approved foreign pharmacy must:
1. Be approved by the office.
2. Submit an application for approval in a form prescribed by the office. The application shall include an application fee as prescribed by the office by rule.
3. Submit an application for renewal of approval each year as prescribed by the office. The application for renewal shall include a renewal fee as prescribed by the office by rule.
4. Be licensed as a pharmacy, or the equivalent, by the jurisdiction in which its dispensing facilities are located.
5. Comply with all applicable federal laws, regulations and standards.
6. Export only prescription medications that are manufactured in facilities that comply with good manufacturing practices and that are approved by the United States food and drug administration.
7. Export only off-patented generic pharmaceuticals to this state for use pursuant to this article.
8. Provide a maximum of a ninety‑day supply for each prescription order.
9. Provide prescription medication only in sealed blister packs or stock bottles.
10. Comply with its jurisdiction's licensure and practice requirements.
11. Be staffed by pharmacists who comply with its jurisdiction's licensure and practice requirements and who are responsible for directing the filling of prescription orders.
12. Provide a toll-free telephone number for its customers to a pharmacist who has access to the records of customers in this state. The telephone service must be available for at least five days each week and for at least forty hours each week. The telephone number must be disclosed on the label attached to each container of prescription medication dispensed to a resident of this state.
13. Maintain the privacy standards prescribed by its licensure jurisdiction.
14. Report to the office and its website director any change of information required by the office.
15. Provide the following information on an annual basis to the office and to the pharmacy's website director:
(a) The name and address of the owner or owners of the pharmacy.
(b) The location of the pharmacy.
(c) The name of each pharmacist who is a managing pharmacist.
(d) Any other information the office determines is necessary to enforce this article.
16. Submit certification satisfactory to the office that the pharmacy complies with all lawful requests and directions from the regulatory board or licensing authority of the jurisdiction in which the pharmacy is located relating to the shipment, mailing or delivery of prescription medication.
17. Provide labeling on prescription medications exported pursuant to this article that complies with United states food and drug administration guidelines and that contains at least the following information:
(a) The patient's name.
(b) The ordering doctor's name.
(c) The pharmacy's address.
(d) The medication dispensed.
(e) The medication strength.
(f) The quantity dispensed.
(g) Directions for the patient.
(h) The number of permitted refills.
(i) The date the prescription was issued.
(j) The symptom or purpose for which the drug was prescribed, if requested by the patient.
18. Make available for inspection all pertinent records, reports, documents or other material or information required by the office to enforce this article.
19. Submit documentation satisfactory to the office that the operation of the pharmacy complies with the laws and regulations of the jurisdiction in which the pharmacy is located.
20. Submit any change in information required pursuant to this section to the office within thirty days after the change.
B. An approved foreign pharmacy may not sell specific patient information and may share this information only with other health care providers to enhance patient care.
c. Notwithstanding subsection D, paragraph 5 of this section, an approved foreign pharmacy may adjust medication quantity to fifteen per cent above or below the quantity ordered in order to use stock in line with the international supply.
D. An approved foreign pharmacy may not sell, distribute or furnish to a resident of this state:
1. A controlled substance.
2. A prescription medication that has not been approved by the United States food and drug administration.
3. A generic prescription medication that has not been approved by the United States Food and Drug Administration.
4. A prescription medication for which the United States food and drug administration has withdrawn or suspended its approval.
5. Except as provided in subsection C of this section, a quantity of prescription medication at one time that includes more than a ninety‑day supply prescribed for the patient.
32-1999.04. Website directors; duties; fees
A. Each website director shall:
1. Apply for registration on a form prescribed by the office.
2. Submit an application fee as prescribed by the office by rule.
3. Renew a registration annually as prescribed by the office.
4. Submit a renewal fee as prescribed by the office by rule.
5. Keep copies of prescriptions on file as required by the Arizona state board of pharmacy pursuant to this chapter.
6. Supervise prescription medications transmitted from approved foreign pharmacies to ensure compliance with state and federal laws.
7. Contract with an independent analytical laboratory to inspect random samples of imported medications on a quarterly basis to assess potency and purity.
8. Assist the office in Ensuring compliance with the requirements of this article.
9. Establish and maintain a website located in this state to facilitate the ordering and importation of prescription medication from approved foreign pharmacies.
B. A website director shall use a website established pursuant to this section only to facilitate the dispensing of prescription medication from approved foreign pharmacies.
C. A website director shall ensure that websites use encrypted information to protect patient confidentiality.
32-1999.05. Patient privacy
The office shall prescribe standards to ensure the following:
1. That specific patient health information is used only to provide pharmaceutical services pursuant to this article.
2. That specific patient health information is shared only with other health care providers to enhance patient care.
3. That patients are informed of the total cost of the prescription medication before the order is finalized.
4. That patients are informed of the location of the approved foreign pharmacy that is filling their prescription order.
32-1999.06. Deposit of fees
All fees collected pursuant to this article shall be deposited in the Arizona state board of pharmacy fund established by section 32-1907.
