HB2682 - 551R - I Ver




REFERENCE TITLE: board of pharmacy; rulemaking authority





State of Arizona

House of Representatives

Fifty-fifth Legislature

First Regular Session





HB 2682


Introduced by

Representative Wilmeth: Senator Navarrete





Amending sections 32   1901, 32   1979.02 and 32   1979.03, Arizona Revised Statutes; relating to the ARizona state board of pharmacy.





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

Section  1.    Section 32-1901, Arizona Revised Statutes, is amended to read:

START_STATUTE32-1901.    Definitions

In this chapter, unless the context otherwise requires:

1.    "Administer" means the direct application of directly applying a controlled substance, prescription   only drug, dangerous drug or narcotic drug, whether by injection, inhalation, ingestion or any other means, to the body of a patient or research subject by a practitioner or by the practitioner's authorized agent or the patient or research subject at the direction of the practitioner.

2.    "Advertisement" means all representations that are disseminated in any manner or by any means,   other than by labeling,   for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of drugs, devices, poisons or hazardous substances.

3.    "Advisory letter" means a nondisciplinary letter to notify a licensee or permittee that either:

(a)    While there is insufficient evidence to support disciplinary action, the board believes that continuation of the activities that led to the investigation may result in further board action against the licensee or permittee.

(b)    The violation is a minor or technical violation that is not of sufficient merit to warrant disciplinary action.

(c)    While the licensee or permittee has demonstrated substantial compliance through rehabilitation, remediation or reeducation that has mitigated the need for disciplinary action, the board believes that repetition of repeating the activities that led to the investigation may result in further board action against the licensee or permittee.

4.    "Antiseptic", if a drug is represented as such on its label, means a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment or dusting powder or other use that involves prolonged contact with the body.

5.    "Authorized officers of the law" means legally empowered peace officers, compliance officers of the board of pharmacy and agents of the division of narcotics enforcement and criminal intelligence of the department of public safety.

6.    "Automated prescription   dispensing kiosk" means a mechanical system that is operated as an extension of a pharmacy, that maintains all transaction information within the pharmacy operating system, that is separately permitted from the pharmacy and that performs operations that either:

(a)    Accept a prescription or refill order, store prepackaged or repackaged medications, label and dispense patient   specific prescriptions and provide counseling on new or refilled prescriptions.

(b)    Dispense or deliver a prescription or refill that has been prepared by or on behalf of the pharmacy that oversees the automated prescription   dispensing kiosk.

7.    "Board" or "board of pharmacy" means the Arizona state board of pharmacy.

8.    "Certificate of composition" means a list of a product's ingredients.

9.    "Certificate of free sale" means a document that authenticates a product that is generally and freely sold in domestic or international channels of trade.

10.    "Color additive" means a material that either:

(a)    Is any dye, pigment or other substance that is made by a process of synthesis or similar artifice,   or that is extracted, isolated or otherwise derived, with or without intermediate or final change of identity, from any vegetable, animal, mineral or other source.

(b)    If added or applied to a drug, or to the human body or any part of the human body, is capable of imparting color, except that color additive does not include any material that has been or may be exempted under the federal act.    Color includes black, white and intermediate grays.

11.    "Compounding" means the preparation preparing, mixing, assembling, packaging or labeling of a drug by a pharmacist or an intern or pharmacy technician under the pharmacist's supervision, for the purpose of dispensing to a patient based on a valid prescription order.   Compounding includes the preparation of preparing drugs in anticipation of prescription orders prepared on routine, regularly observed prescribing patterns and the preparation of preparing drugs as an incident to research, teaching or chemical analysis or for administration by a medical practitioner to the medical practitioner's patient and not for sale or dispensing.   Compounding does not include the preparation of preparing commercially available products from bulk compounds or the preparation of preparing drugs for sale to pharmacies, practitioners or entities for the purpose of dispensing or distribution.

12.    "Compressed medical gas distributor" means a person who that holds a current permit issued by the board to distribute compressed medical gases pursuant to a compressed medical gas order to compressed medical gas suppliers and other entities that are registered, licensed or permitted to use, administer or distribute compressed medical gases.

13.    "Compressed medical gases" means gases and liquid oxygen that a compressed medical gas distributor or manufacturer has labeled in compliance with federal law.

14.    "Compressed medical gas order" means an order for compressed medical gases that is issued by a medical practitioner.

15.    "Compressed medical gas supplier" means a person who that holds a current permit issued by the board to supply compressed medical gases pursuant to a compressed medical gas order and only to the consumer or the patient.

16.    "Controlled substance" means a drug, substance or immediate precursor that is identified, defined or listed in title 36, chapter 27, article 2.

17.    "Corrosive" means any substance that when it comes in contact with living tissue will cause destruction of the tissue by chemical action.

18.    "Counterfeit drug" means a drug that, or the container or labeling of which, without authorization, bears the trademark, trade name or other identifying mark, imprint, number or device, or any likeness of these, of a manufacturer, distributor or dispenser other than the person who that in fact manufactured, distributed or dispensed that drug.

19.    "Dangerous drug" has the same meaning prescribed in section 13   3401.

20.    "Day" means a business day.

21.    "Decree of censure" means an official action that is taken by the board and that may include a requirement for restitution of fees to a patient or consumer.

22.    "Deliver" or "delivery" means the actual, constructive or attempted transfer from one person to another whether or not there is an agency relationship.

23.    "Deputy director" means a pharmacist who is employed by the board and selected by the executive director to perform duties as prescribed by the executive director.

24.    "Device", except as used in paragraph 18 of this section, section 32   1965, paragraph 4 and section 32   1967, subsection A, paragraph 15 and subsection C, means instruments an instrument, apparatuses and contrivances apparatus or contrivance, including their its components, parts and accessories, including all such items under the federal act, that is intended either:

(a)    For use in the diagnosis, cure, mitigation, treatment or prevention of diagnosing, curing, mitigating, treating or preventing disease in the human body or other animals.

(b)    To affect the structure or any function of the human body or other animals.

25.    "Director" means the director of the division of narcotics enforcement and criminal investigation of the department of public safety.

26.    "Direct supervision of a pharmacist" means that the pharmacist is present.   If relating to the sale of certain items, direct supervision of a pharmacist means that a pharmacist determines the legitimacy or advisability of a proposed purchase of those items.

27.    "Dispense" means to deliver to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling or compounding as necessary to prepare for that delivery.

28.    "Dispenser" means a practitioner who dispenses.

29.    "Distribute" means to deliver, other than by administering or dispensing.

30.    "Distributor" means a person who distributes.

31.    "Drug" means:

(a)    Articles that are recognized, or for which standards or specifications are prescribed, in the official compendium.

(b)    Articles that are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in the human body or other animals.

(c)    Articles other than food that are intended to affect the structure or any function of the human body or other animals.

(d)    Articles that are intended for use as a component of any articles specified in subdivision (a), (b) or (c) of this paragraph but does not include devices or their components, parts or accessories.

32.    "Drug enforcement administration" means the drug enforcement administration of the United States department of justice or its successor agency.

33.    "Drug or device manufacturing" means the production producing, preparation preparing, propagation propagating or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis and includes any packaging or repackaging of substances or labeling or relabeling of its container and the promotion promoting and marketing of the same.    Drug or device manufacturing does not include compounding.

34.    "Economic poison" means any substance that alone, in chemical combination with or in formulation with one or more other substances is a pesticide within the meaning of the laws of this state or the federal insecticide, fungicide and rodenticide act and that is used in the production producing, storage storing or transportation of transporting raw agricultural commodities.

35.    "Enteral feeding" means nourishment that is provided by means of a tube inserted into the stomach or intestine.

36.    "Established name", with respect to a drug or ingredient of a drug, means any of the following:

(a)    The applicable official name.

(b)    If there is no such name and the drug or ingredient is an article recognized in an official compendium, the official title in an official compendium.

(c)    If neither subdivision (a) nor (b) of this paragraph applies, the common or usual name of the drug.

37.    "Executive director" means the executive director of the board of pharmacy.

38.    "Federal act" means the federal laws and regulations that pertain to drugs, devices, poisons and hazardous substances and that are official at the time any drug, device, poison or hazardous substance is affected by this chapter.

39.    "Full service wholesale permittee":

(a)    Means a permittee who may distribute prescription   only drugs and devices, controlled substances and over   the   counter drugs and devices to pharmacies or other legal outlets from a place devoted in whole or in part to wholesaling these items.

(b)    Includes a virtual wholesaler as defined in rule by the board.  

40.    "Good manufacturing practice" means a system for ensuring that products are consistently produced and controlled according to quality standards and covering all aspects of design, monitoring and control of manufacturing processes and facilities to ensure that products do not pose any risk to the consumer or public.

41.    "Highly toxic" means any substance that falls within any of the following categories:

(a)    Produces death within fourteen days in half or more than half of a group of ten or more laboratory white rats each weighing between two hundred and three hundred grams, at a single dose of fifty milligrams or less per kilogram of body weight, when orally administered.

(b)    Produces death within fourteen days in half or more than half of a group of ten or more laboratory white rats each weighing between two hundred and three hundred grams, if inhaled continuously for a period of one hour or less at an atmospheric concentration of two hundred parts per million by volume or less of gas or vapor or two milligrams per liter by volume or less of mist or dust, provided the concentration is likely to be encountered by humans if the substance is used in any reasonably foreseeable manner.

(c)    Produces death within fourteen days in half or more than half of a group of ten or m