No. 34887 (Amendment): Section R156-17b-310. Exemption from Licensure - Physicians Dispensing Cosmetic Drug or Injectable Weight Loss Drug

(Amendment)

DAR File No.: 34887
Filed: 05/31/2011 10:52:22 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This proposed rule filing implements changes made by the Legislature in S.B. 128 (2011 General Session). It also makes technical and cleanup changes. (DAR NOTE: S.B. 128 (2011) was effective 05/10/2011.)

Summary of the rule or change:

This filing expands the dispensing of cosmetic and weight loss drug exemption in the Pharmacy Practice Act implementation language to include advanced practice registered nurses, physician assistants, and optometrists. Otherwise, the substance of the existing rule remains unchanged. The filing also makes technical and clarifying changes.

State statutory or constitutional authorization for this rule:

• Subsection 58-17b-601(1)
• Section 58-17b-101
• Subsection 58-1-106(1)(a)
• Section 58-37-1
• Subsection 58-1-202(1)(a)

Anticipated cost or savings to:

the state budget:

The Division will incur minimal costs of approximately $100 to print and distribute the rule once the proposed amendments are made effective. Any costs incurred will be absorbed in the Division's current budget. No additional costs or savings are anticipated by the addition of these additional professions that may dispense a cosmetic or weight loss drug.

local governments:

The proposed amendments only apply to certain licensed professions who may dispense a cosmetic or weight loss drug. As a result, the proposed amendments do not apply to local governments.

small businesses:

There may be a cost savings or loss to prescribing practitioners or optometrists depending on the dynamics of the free market. This impact cannot be estimated by the Division.

persons other than small businesses, businesses, or local governmental entities:

There may be a cost savings or loss to prescribing practitioners or optometrists depending on the dynamics of the free market. This impact cannot be estimated by the Division.

Compliance costs for affected persons:

There may be a cost savings or loss to prescribing practitioners or optometrists depending on the dynamics of the free market. This impact cannot be estimated by the Division.

Comments by the department head on the fiscal impact the rule may have on businesses:

This rule filing implements a recent statutory change made in the 2011 General Session in expanding the exemptions in the Pharmacy Practice Act for which the fiscal impact to businesses has already been addressed. No fiscal impact to businesses is anticipated from other technical and clarifying changes in the rule.

Francine A. Giani, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Commerce
Occupational and Professional Licensing
160 E 300 S
SALT LAKE CITY, UT 84111-2316

Direct questions regarding this rule to:

• W. Ray Walker at the above address, by phone at 801-530-6256, by FAX at 801-530-6511, or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

07/15/2011

This rule may become effective on:

07/22/2011

Authorized by:

Mark Steinagel, Director

RULE TEXT

R156. Commerce, Occupational and Professional Licensing.

R156-17b. Pharmacy Practice Act Rule.

R156-17b-310. Exemption from Licensure - [Physicians ]Dispensing of Cosmetic [Drug]or Injectable Weight Loss Drugs.

(1) A cosmetic drug that can be dispensed by a [physician licensed under either Title 58, Chapter 67, Utah Medical Practice Act, or Title 58, Chapter 68, Utah Osteopathic Medical Practice Act, and]prescribing practitioner or optometrist in accordance with Subsection 58-17b-309[(1)(a) includes:

(a)] is limited to Latisse.

(2) An injectable weight loss drug that can be dispensed by a [physician licensed under either Title 58, Chapter 67, Utah Medical Practice Act, or Title 58, Chapter 68, Utah Osteopathic Medical Practice Act, and]prescribing practitioner in accordance with Subsection 58-17b-309[(1)(b) includes:

(a)] is limited to human chorionic gonadotropin.

(3) In accordance with Subsection 58-17b-309(4)(c), a [physician]prescribing practitioner or optometrist who chooses to dispense a cosmetic drug , or a prescribing practitioner who chooses to dispense an injectable weight loss drug , as listed in Subsections (1) and (2) , to the [physician's]prescribing practitioner's or optometrist's patients shall have a label securely affixed to the container indicating the following minimum information:

(a) the name, address and telephone number of the [physician]prescribing practitioner or optometrist prescribing and dispensing the drug;

(b) the serial number of the prescription as assigned by the dispensing [physician]prescribing practitioner or optometrist;

(c) the filling date of the prescription or its last dispensing date;

(d) the name of the patient;

(e) the directions for use and cautionary statements, if any, which are contained in the prescription order or are needed;

(f) the trade, generic or chemical name, amount dispensed and the strength of dosage form; and

(g) the beyond use date.

(4) A [physician]prescribing practitioner or optometrist who chooses to dispense a cosmetic drug , or a prescribing practitioner who chooses to dispense an injectable weight loss drug , as listed in Subsections (1) and (2) , shall keep inventory records for each drug dispensed and a prescription dispensing medication profile for each patient receiving a drug dispensed by the [physician]prescribing practitioner or optometrist. Those records shall be made available to the Division upon request by the Division.

(a) The general requirements for an inventory of drugs dispensed by a [physician]prescribing practitioner or optometrist include:

(i) the [physician]prescribing practitioner or optometrist shall be responsible for taking all required inventories, but may delegate the performance of taking the inventory to another person;

(ii) the inventory records must be maintained for a period of five years and be readily available for inspection;

(iii) the inventory records shall be filed separately from all other records;

(iv) the person taking the inventory and the [physician]prescribing practitioner or optometrist shall indicate the time the inventory was taken and shall sign and date the inventory with the date the inventory was taken. The signature of the [physician]prescribing practitioner or optometrist and the date of the inventory shall be documented within 72 hours or three working days of the completed initial, annual, change of ownership and closing inventory;

(v) the initial inventory shall be completed within three working days of the date on which the [physician]prescribing practitioner or optometrist begins to dispense a drug under Section 58-17b-309; and

(vi) the annual inventory shall be within 12 months following the inventory date of each year and may be taken within four days of the specified inventory date and shall include all stocks including out-of-date drugs.

(b) A prescription dispensing medication profile shall be maintained for every patient receiving a drug that is dispensed by a [physician]prescribing practitioner or optometrist in accordance with Section 58-17b-309 for a period of at least one year from the date of the most recent prescription fill or refill. The medication profile shall be kept as part of the patient's medical record and include, as a minimum, the following information:

(i) full name of the patient, address, telephone number, date of birth or age, and gender;

(ii) patient history where significant, including known allergies and drug reactions; and

(iii) a list of drugs being dispensed including:

(A) name of prescription drug;

(B) strength of prescription drug;

(C) quantity dispensed;

(D) prescription drug lot number and name of manufacturer;

(E) date of filling or refilling;

(F) charge for the prescription drug as dispensed to the patient;

(G) any additional comments relevant to the patient's drug use; and

(H) documentation that patient counseling was provided in accordance with Subsection (5).

(5) A [physician]prescribing practitioner or optometrist who is dispensing a cosmetic drug or injectable weight loss drug listed in Subsections (1) and (2) in accordance with Subsection 58-17b-309(4)(c), shall include the following elements when providing patient counseling:

(a) the name and description of the prescription drug;

(b) the dosage form, dose, route of administration and duration of drug therapy;

(c) intended use of the drug and expected action;

(d) special directions and precautions for preparation, administration and use by the patient;

(e) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

(f) techniques for self-monitoring drug therapy;

(g) proper storage;

(h) prescription refill information;

(i) action to be taken in the event of a missed dose;

(j) [physician]prescribing practitioner or optometrist comments relevant to the individual's drug therapy, including any other information specific to the patient or drug; and

(k) the date after which the prescription should not be taken or used, or the beyond use date.

(6) In accordance with Subsection 58-17b[(]-309[)](4)(c), the medication storage standards that must be maintained by a [physician]prescribing practitioner or optometrist who dispenses a drug under Subsection s (1) and (2) provides that the storage space shall be:

(a) kept in an area that is well lighted, well ventilated, clean and sanitary;

(b) equipped to permit the orderly storage of prescription drugs in a manner to permit clear identification, separation and easy retrieval of products and an environment necessary to maintain the integrity of the drug inventory;

(c) equipped with a security system to permit detection of entry at all times when the [physician's]prescribing practitioner's or optometrist's office or clinic is closed;

(d) at a temperature which is maintained within a range compatible with the proper storage of drugs; and

(e) securely locked with only the [physician]prescribing practitioner or optometrist having access when the [physician's]prescribing practitioner's or optometrist's office or clinic is closed.

(7) In accordance with Subsection 58-17b-309(5), if a cosmetic drug or a weight loss drug listed in Subsections (1) and (2) requires reconstitution or compounding to prepare the drug for administration, the [physician]prescribing practitioner or optometrist shall follow the USP-NF 797 standards for sterile compounding.

(8) In accordance with Subsection 58-17b-309(5), factors that shall be considered by [the Utah State Board of Pharmacy, the Utah Physicians Licensing Board, and the Utah Osteopathic Physician and Surgeon's Licensing Board]licensing boards when determining if a drug may be dispensed by a [physician]prescribing practitioner or optometrist, include whether:

(a)(i) the drug has FDA approval;

(ii)(A) is prescribed and dispensed for the conditions or indication for which the drug was approved to treat; or

(B) the [physician]prescribing practitioner or optometrist takes full responsibility for prescribing and dispensing a drug for off-label use;

(b) the drug has been approved for self administration by the FDA;

(c) the stability of the drug is adequate for the supply being dispensed; and

(d) the drug can be safely dispensed by a prescribing practitioner or optometrist.

 

KEY: pharmacists, licensing, pharmacies

Date of Enactment or Last Substantive Amendment: [October 22, 2010]2011

Notice of Continuation: February 23, 2010

Authorizing, and Implemented or Interpreted Law: 58-17b-101; 58-17b-601(1); 58-37-1; 58-1-106(1)(a); 58-1-202(1)(a)

 

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