Reference Title: contact lenses; pharmacies; prescription sales

AN ACT
AMENDING SECTIONS 32-1691, 32-1963.01, 32-1964 AND 32-1968, ARIZONA REVISED STATUTES; AMENDING TITLE 32, CHAPTER 16, ARIZONA REVISED STATUTES, BY ADDING ARTICLE 5; AMENDING TITLE 32, CHAPTER 18, ARTICLE 3, ARIZONA REVISED STATUTES, BY ADDING SECTION 32-1968.01; RELATING TO PHARMACY.

Be it enacted by the Legislature of the State of Arizona:

Section 1. Section 32-1691, Arizona Revised Statutes, is amended to read:

32-1691 . Exemptions of persons and sales

This chapter shall DOES not apply to:

1. Any physician or optometrist duly licensed to practice under the laws of this state.

2. Any person working under the direct supervision of a physician, optometrist or dispensing optician duly licensed to practice in this state, so AS long as the person is working exclusively for the licensed physician, optometrist or dispensing optician and does not hold himself out to the public as CLAIM TO BE a dispensing optician.

3. The sale of goggles, sunglasses, colored glasses or occupational protective eye devices, if they do not have refractive values.

4. The sale of complete ready-to-wear eyeglasses, toys, binoculars or scientific instruments as merchandise.

5. The sale and fitting of ocular prosthetic appliances if they do not have refractive values.

6. THE SALE OF REPLACEMENT OF SOFT CONTACT LENSES AS PROVIDED IN CHAPTER 16, ARTICLE 5 AND CHAPTER 18 OF THIS TITLE.

Sec. 2. Title 32, chapter 16, Arizona Revised Statutes, is amended by adding article 5, to read:

article 5. Replacement soft contact lenses

32-1771 . Definitions

FOR PURPOSES OF THIS ARTICLE, EXCEPT AS THE CONTEXT OTHERWISE REQUIRES:

1. "NONRESIDENT DISPENSER" MEANS A PERSON NOT DOMICILED IN THIS STATE WHO IS LICENSED IN THE PERSON'S STATE OF DOMICILE TO DISPENSE REPLACEMENT SOFT CONTACT LENSES AND WHO DISPENSES REPLACEMENT CONTACT LENSES TO PATIENTS IN THIS STATE.

2. "QUALIFIED DISPENSER" MEANS A NONRESIDENT DISPENSER HOLDING A CURRENT REGISTRATION WITH THE BOARD.

3. "REPLACEMENT SOFT CONTACT LENSES" MEANS HYDROPHILIC LENSES REQUIRING NO FITTING OR ADJUSTMENT THAT ARE DISPENSED AS PACKAGED AND SEALED BY THE MANUFACTURER.

32-1772 . Exemptions

THIS ARTICLE DOES NOT APPLY TO:

1. PHYSICIANS LICENSED UNDER CHAPTER 13 OR 17 OF THIS TITLE.

2. DOCTORS OF OPTOMETRY LICENSED UNDER CHAPTER 16 OF THIS TITLE.

3. DISPENSING OPTICIANS LICENSED UNDER CHAPTER 15.1 OF THIS TITLE.

4. A PHARMACIST AND A PHARMACY LICENSED UNDER CHAPTER 18 OF THIS TITLE.

32-1773 . Registration of nonresident dispensers replacement soft contact lenses; qualifications; fee

A. A NONRESIDENT DISPENSER MAY REGISTER WITH THE BOARD TO DISPENSE REPLACEMENT SOFT CONTACT LENSES. REGISTRATION SHALL BE EFFECTIVE FOR TWO YEARS AND SUBJECT TO RENEWAL.

B. THE BOARD SHALL SET A FEE FOR REGISTRATION AND FOR RENEWAL OF REGISTRATION.

C. APPLICANTS FOR REGISTRATION OR RENEWAL SHALL PROVIDE TO THE BOARD AT THE TIME FOR REGISTRATION OR RENEWAL ON A FORM PRESCRIBED BY THE BOARD THEIR NAME, ADDRESS, NAME OF PRINCIPAL CORPORATE OFFICERS, IF ANY, AND NAME OF ALL GENERAL PARTNERS, IF ANY. THE REGISTRATION SHALL BE ACCOMPANIED BY THE REQUIRED FEE AND A CERTIFIED COPY OF THE APPLICANT'S LICENSE FROM THE LICENSING AUTHORITY IN THEIR STATE OF DOMICILE AND OTHER INFORMATION THE BOARD REQUIRES.

D. REGISTERED DISPENSERS SHALL SUBMIT A REPORT TO THE BOARD WITHIN THIRTY DAYS OF THE CHANGE OF ITS ADDRESS, ANY OFFICER, PARTNER OR PHARMACIST OR OF THE STATUS OF ITS LICENSE IN THE STATE OF DOMICILE.

E. REGISTERED DISPENSERS SHALL MAINTAIN AT ALL TIMES A VALID UNEXPIRED LICENSE, PERMIT OR REGISTRATION TO CONDUCT THE BUSINESS OF A PHARMACIST OR PHARMACY IN THEIR STATE OF DOMICILE.

F. THE BOARD MAY SUSPEND, REVOKE OR REFUSE TO RENEW THE REGISTRATION OF A REGISTERED DISPENSER OR IMPOSE A CIVIL SANCTION AGAINST A REGISTERED DISPENSER OR ANY OTHER PERSON WHO:

1. VIOLATES THIS ARTICLE.

2. OBTAINED A REGISTRATION BY FRAUDULENT OR OTHER MATERIAL MISREPRESENTATION.

3. HAS BEEN CONVICTED OF A FELONY.

4. HAS HAD THEIR LICENSE SUSPENDED OR REVOKED IN ANY OTHER JURISDICTION.

5. VIOLATES ANY OTHER ARIZONA OR FEDERAL LAW REGULATING THE DISPENSING OF REPLACEMENT CONTACT LENSES.

6. COMMITS AN OFFENSE IN ANOTHER JURISDICTION WHICH WOULD BE GROUNDS FOR REVOCATION OR SUSPENSION IN THIS JURISDICTION.

G. THE BOARD SHALL ISSUE A COMPLAINT TO THE REGISTRANT AND SET A HEARING, WHICH SHALL CONFORM TO THE REQUIREMENTS OF TITLE 41, CHAPTER 6.

32-1774 . Replacement soft contact lenses; prescriptions; filling

A. A NONRESIDENT DISPENSER MAY NOT FILL A PRESCRIPTION FOR REPLACEMENT SOFT CONTACT LENSES WITHOUT FIRST HAVING REGISTERED WITH THE BOARD. A QUALIFIED DISPENSER MAY FILL A PRESCRIPTION FOR REPLACEMENT SOFT CONTACT LENSES ONLY AS PROVIDED IN THIS SECTION.

B. A QUALIFIED DISPENSER MAY FILL A PRESCRIPTION FOR REPLACEMENT SOFT CONTACT LENSES THAT MEETS ALL OF THE FOLLOWING REQUIREMENTS:

1. CONFORMS TO STATE AND FEDERAL STATUTES AND REGULATIONS GOVERNING THOSE PRESCRIPTIONS AND INCLUDES THE NAME, OFFICE ADDRESS, SIGNATURE AND STATE LICENSE NUMBER OF THE PRESCRIBING PHYSICIAN OR OPTOMETRIST.

2. EXPLICITLY STATES THE DATE OF ISSUANCE.

3. EXPLICITLY STATES THAT THE PRESCRIPTION IS FOR CONTACT LENSES AND INCLUDES THE LENS BRAND NAME, TYPE, TINT AND ALL OTHER SPECIFICATIONS NECESSARY TO ACCURATELY DISPENSE THE PRESCRIPTION.

C. THE QUALIFIED DISPENSER SHALL FILL THE PRESCRIPTION WITH THE EXACT LENSES PRESCRIBED AND NO SUBSTITUTIONS SHALL BE MADE. THE EXPIRATION DATE OF THE PRESCRIPTION SHALL BE THE EARLIER OF THE EXPIRATION DATE PROVIDED BY THE PRESCRIBING PHYSICIAN OR OPTOMETRIST OR ONE YEAR AFTER THE DATE OF ISSUANCE. THE QUALIFIED DISPENSER SHALL FILL A REFILL OF A PRESCRIPTION THAT IS WITHIN SIXTY DAYS OF ITS EXPIRATION DATE WITH NO MORE THAN THE SUFFICIENT QUANTITY OF REPLACEMENT SOFT CONTACT LENSES NEEDED THROUGH THE EXPIRATION DATE. THE QUALIFIED DISPENSER SHALL ENSURE THAT PRESCRIPTIONS ARE FILLED ACCURATELY.

D. THE QUALIFIED DISPENSER SHALL PROVIDE THE FOLLOWING OR SUBSTANTIALLY EQUIVALENT WRITTEN NOTIFICATION TO THE PATIENT WHENEVER CONTACT LENSES ARE SUPPLIED:

WARNING: IF YOU ARE HAVING ANY UNEXPLAINED EYE DISCOMFORT, WATERING, VISION CHANGE OR REDNESS, REMOVE YOUR LENSES IMMEDIATELY AND CONSULT YOUR EYE CARE PRACTITIONER BEFORE WEARING YOUR LENSES AGAIN.

E. ANY ADVERTISEMENT BY A QUALIFIED DISPENSER FOR REPLACEMENT SOFT CONTACT LENSES SHALL INCLUDE ALL FEES, CHARGES AND COSTS ASSOCIATED WITH THE PURCHASE OF REPLACEMENT SOFT CONTACT LENSES FROM THE QUALIFIED DISPENSER.

F. DURING ITS REGULAR HOURS OF OPERATION, BUT AT LEAST SIX DAYS PER WEEK AND FOR AT LEAST FORTY HOURS PER WEEK, A QUALIFIED NONRESIDENT DISPENSER SHALL MAINTAIN A TOLL FREE TELEPHONE SERVICE TO FACILITATE COMMUNICATION BETWEEN PATIENTS IN THIS STATE AND A REGISTERED DISPENSER WHO HAS ACCESS TO THE PATIENT'S RECORDS. THIS TOLL FREE NUMBER SHALL BE DISCLOSED ON A LABEL AFFIXED TO EACH CONTAINER OF REPLACEMENT SOFT CONTACT LENSES DISPENSED TO PATIENTS IN THIS STATE.

G. QUALIFIED DISPENSERS SHALL MAINTAIN RECORDS OF REPLACEMENT SOFT CONTACT LENSES DISPENSED TO PATIENTS IN THIS STATE SEPARATE FROM RECORDS FOR PATIENTS IN OTHER STATES SUCH THAT THE RECORDS FOR PATIENTS IN THIS STATE ARE READILY RETRIEVABLE. RECORDS SHALL BE MAINTAINED FOR A PERIOD OF AT LEAST THREE YEARS. RECORDS SHALL BE AVAILABLE FOR INSPECTION AT THE BOARD'S REQUEST.

Sec. 3. Section 32-1963.01, Arizona Revised Statutes, is amended to read:

32-1963.01 . Substitution for prescription drugs; requirements; cost to patient; label; definitions

A. When a medical practitioner prescribes a brand name drug and permits substitution, a pharmacist may fill the prescription with a generic equivalent drug.

B. Before a substitution is made pursuant to this section, the pharmacist shall notify the person presenting the prescription of the amount of the price difference between the brand name drug prescribed and the generic equivalent drug.

C. When a substitution is made pursuant to this section, the pharmacist shall note on the prescription and include on the label of the container the name of the dispensed drug and the name of the manufacturer or distributor of the dispensed generic equivalent drug or abbreviations of such information approved by the board. The pharmacist may SHALL place on the container the name of the drug dispensed followed by the words "generic equivalent for" followed by a THE brand or trade name of a THE product that meets the requirements of this section IS BEING REPLACED BY THE GENERIC EQUIVALENT. THE PHARMACIST SHALL INCLUDE THE BRAND OR TRADE NAME ON THE CONTAINER OR LABEL OF ANY CONTACT LENSES DISPENSED PURSUANT TO THIS CHAPTER .

D. Every prescription form in this state shall contain two signature lines for the prescriber. The right side of the prescription form shall contain under the signature line the phrase "substitution permissible". The left side shall contain under the signature line the phrase "dispense as written". In the instance of an oral prescription, the pharmacist shall note the prescriber's instructions on the face of the prescription. A prescription from out of state or from agencies of the United States government need not have two signature lines and is required to be dispensed as written only if the prescriber has stated "do not substitute", "dispense as written" or "medically necessary" or any statement by the prescriber which clearly indicates an intent to prevent substitution on the face of the prescription form.

E. This section shall apply to all prescriptions, including those presented by or on behalf of persons receiving state or federal assistance payments.

F. An employer or agent of an employer of a pharmacist shall not require the pharmacist to dispense any specific generic equivalent drug or substitute any specific generic equivalent drug for a brand name drug against the professional judgment of the pharmacist or the order of the prescriber.

G. The liability of a pharmacist in substituting according to this section shall be no greater than that which is incurred in the filling of a generically written prescription. This subsection does not limit or diminish the responsibility for the strength, purity or quality of drugs provided in section 32-1963. The failure of a prescriber to specify that no substitution is authorized does not constitute evidence of negligence.

H. A pharmacist may not make a substitution pursuant to this section unless the manufacturer or distributor of the generic drug has shown that:

1. All products dispensed have an expiration date on the original package.

2. The manufacturer or distributor maintains recall and return capabilities for unsafe or defective drugs and a statement describing such capabilities is on file with the board of pharmacy.

3. The manufacturer or distributor has a liability statement relative to its drug products on file with the board of pharmacy.

I. The labeling and oral notification requirements of this section do not apply to pharmacies serving patients in a health care institution as defined in section 36-401. However, in order for this exemption to apply to hospitals, the hospital must have a formulary to which all medical practitioners of that hospital have agreed and which is available for inspection by the board.

J. A medical practitioner shall write a drug order on a form which provides the practitioner with a means of conspicuously indicating whether a generic equivalent drug may be used.

K. The board by rule shall establish a list of drugs that shall not be used by dispensing pharmacists as generic equivalents for substitution.

L. In this section:

1. "Brand name drug" means a drug with a proprietary name assigned to it by the manufacturer or distributor.

2. "Formulary" means a list of medicinal drugs.

3. "Generic equivalent" or "generically equivalent" means a drug which has an identical amount of the same active chemical ingredients in the same dosage form, which meets applicable standards of strength, quality and purity according to the United States pharmacopeia or other nationally recognized compendium and which, if administered in the same amounts, will provide comparable therapeutic effects. Generic equivalent or generically equivalent does not include a drug that is listed by the federal food and drug administration as having unresolved bioequivalence concerns according to the administration's most recent publication of approved drug products with therapeutic equivalence evaluations.

Sec. 4. Section 32-1964, Arizona Revised Statutes, is amended to read:

32-1964 . Record of prescription orders; inspections

Every proprietor, manager, or pharmacist in charge of a pharmacy shall keep in his pharmacy a suitable book or file in which shall be preserved, for a period of not less than three years, the original of every prescription order OF DRUGS OR REPLACEMENT SOFT CONTACT LENSES, compounded or dispensed at the pharmacy, serially numbered, dated and filed in the order in which they were compounded or dispensed, and shall produce such book or file in court or before any grand jury upon lawful order. THE BOARD SHALL, BY RULE, PERMIT PHARMACIES TO MAINTAIN THE BOOK OR FILE OF ALL ORIGINAL PRESCRIPTION ORDERS BY MEANS OF ELECTRONIC MEDIA OR IMAGE OF THE ORIGINAL PRESCRIPTION ORDER MAINTAINED IN A RETRIEVABLE FORMAT IN A FORM THAT CONTAINS INFORMATION THE BOARD REQUIRES TO PROVIDE AN ADEQUATE RECORD OF DRUGS OR REPLACEMENT SOFT CONTACT LENSES COMPOUNDED OR DISPENSED. The board shall, by rule, require a similar book or file for a hospital pharmacy in such A form and with such THAT CONTAINS information as the board requires to provide an adequate record of drugs compounded or dispensed. The book or file of original prescription orders shall at all times be open for inspection by the medical practitioner prescribing, the board and officers of the law in performance of their duties.

Sec. 5. Section 32-1968, Arizona Revised Statutes, is amended to read:

32-1968 . Dispensing prescription-only drug; prescription orders; renewals; labels; misbranding; dispensing soft contact lenses

A. A prescription-only drug shall be dispensed only under one of the following conditions:

1. By a medical practitioner in conformance with section 32-1921.

2. Upon a written prescription order.

3. Upon an oral prescription order which is reduced promptly to writing and filed by the pharmacist.

4. By renewing any such written or oral prescription order , if such A renewal is authorized by the prescriber either in the original prescription order or by AN oral order , which THAT is reduced promptly to writing and filed by the pharmacist.

B. A prescription order shall not be renewed if it is either:

1. Ordered by the prescriber not to be renewed.

2. More than one year since it was originally ordered.

C. A prescription order shall contain the date it was issued, the name and address of the person for whom or owner of the animal for which the drug is ordered, the name, strength and quantity of the drug ordered and directions for its use. A written prescription order shall contain the printed name of the prescriber.

D. Any drug dispensed in accordance with subsection A of this section is exempt from the requirements of section 32-1967, except subsection A, paragraphs 1, 10 and 11 and the packaging requirements of subsection A, paragraphs 7 and 8, if the drug container bears a label containing the name and address of the dispenser, serial number, date of dispensing, name of the prescriber, name of the patient, or, if an animal, the name of the owner of the animal and the species of the animal, directions for use and cautionary statements, if any, contained in the order. This exemption does not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or to a drug dispensed in violation of subsection A of this section.

E. The board may also by rule require additional information on the label of prescription medication which the board believes to be necessary for the best interest of the public's health and welfare.

F. A prescription-only drug or a controlled substance which THAT requires a prescription order is deemed to be misbranded if, at any time prior to dispensing, its label fails to bear the statement, "Caution: Federal law prohibits dispensing without prescription." A drug to which subsection A of this section does not apply is deemed to be misbranded if, at any time prior to dispensing, its label bears the caution statement quoted in this subsection.

G. A PHARMACIST MAY FILL A PRESCRIPTION ORDER FOR SOFT CONTACT LENSES ONLY AS PROVIDED IN THIS CHAPTER.

Sec. 6. Title 32, chapter 18, article 3, Arizona Revised Statutes, is amended by adding section 32-1968.01, to read:

32-1968.01 . Dispensing replacement soft contact lenses; prescription

A. A PRESCRIPTION ORDER FOR REPLACEMENT SOFT CONTACT LENSES MAY BE DISPENSED UNDER THE FOLLOWING CONDITIONS:

1. THE PRESCRIPTION ORDER SHALL BE IN THE FORM REQUIRED BY THIS CHAPTER AND SHALL INCLUDE THE NAME OF THE PRESCRIBING PHYSICIAN OR OPTOMETRIST.

2. THE PRESCRIPTION ORDER CONTAINS THE DATE OF ISSUANCE.

3. THE PRESCRIPTION ORDER FOR CONTACT LENSES INCLUDES THE LENS BRAND NAME, TYPE, TINT AND ALL OTHER SPECIFICATIONS NECESSARY TO ACCURATELY DISPENSE THE PRESCRIPTION.

B. THE PRESCRIPTION SHALL BE DISPENSED WITH THE EXACT LENSES PRESCRIBED AND NO SUBSTITUTIONS SHALL BE MADE. THE EXPIRATION DATE OF THE PRESCRIPTION SHALL BE THE EARLIER OF THE EXPIRATION DATE PROVIDED BY THE PRESCRIBING PHYSICIAN OR OPTOMETRIST OR ONE YEAR AFTER THE DATE OF ISSUANCE. A REFILL OF A PRESCRIPTION THAT IS WITHIN SIXTY DAYS OF ITS EXPIRATION DATE SHALL BE FILLED WITH NO MORE THAN THE SUFFICIENT QUANTITY OF REPLACEMENT SOFT CONTACT LENSES NEEDED THROUGH THE EXPIRATION DATE.

C. THE PRESCRIPTION SHALL BE DISPENSED WITH A WRITTEN NOTICE CONTAINING THE FOLLOWING WORDING OR ITS SUBSTANTIAL EQUIVALENT:

WARNING: IF YOU ARE HAVING ANY UNEXPLAINED EYE DISCOMFORT, WATERING, VISION CHANGE OR REDNESS, REMOVE YOUR LENSES IMMEDIATELY AND CONSULT YOUR EYE CARE PRACTITIONER BEFORE WEARING YOUR LENSES AGAIN.

D. ANY ADVERTISEMENT BY A PHARMACY OR PHARMACIST FOR REPLACEMENT SOFT CONTACT LENSES SHALL INCLUDE ALL CHARGES ASSOCIATED WITH THE PURCHASE OF REPLACEMENT SOFT CONTACT LENSES FROM THE PHARMACY OR PHARMACIST.

APPROVED BY THE GOVERNOR APRIL 24, 1997.

FILED IN THE OFFICE OF THE SECRETARY OF STATE APRIL 24, 1997.