Commerce, Occupational and Professional Licensing

Section R156-17b-310

Exemption from Licensure - Physicians Dispensing Cosmetic Drug or Injectable Weight Loss Drug

Notice of Proposed Rule

(Amendment)

DAR File No.: 33972
Filed: 08/19/2010 07:50:49 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this rule amendment is to implement the legislative changes enacted as a result of passage of S.B. 88, Pharmacy Practice Act Amendments, sponsored by Senator Curtis Bramble. The bill exempts a physician or osteopathic physician from the practice of pharmacy as it applies to the dispensing of a cosmetic drug or injectable weight loss drug. The statute requires the Division to adopt rules to specify the drugs that can be dispensed from a physician's office under the new exemption and also provides authority to the Division to implement an administrative rule to address labeling, record keeping, patient counseling, and storage requirements. (DAR NOTE: S.B. 88 (2010) is found at Chapter 213, Laws of Utah 2010, and was effective 05/11/2010.)

Summary of the rule or change:

A new Section R156-17b-310 is established to implement S.B. 88. Subsection R156-17b-310(1) identifies Latisse as a cosmetic drug that can be dispensed by a physician. Subsection R156-17b-310(2) identifies human chorionic gonadotropin (HCG) as an injectable weight loss drug that can be dispensed under this new exemption. Subsection R156-17b-310(3) establishes the standards for a label that is affixed to a drug dispensed by a physician. Subsection R156-17b-310(4) establishes the record keeping standards, including requirements for a medication profile, which must be followed by a physician who chooses to dispense drugs under this Section. Subsection R156-17b-310(5) establishes the standard for patient counseling required if a physician dispenses a cosmetic or injectable weight loss drug in accordance with this Section. Subsection R156-17b-310(6) establishes the storage standards for the drugs listed in Subsections R156-17b-310(1) and R156-17b-310(2). Subsection R156-17b-310(7) requires a physician dispensing a cosmetic or injectable weight loss drug that requires reconstitution or compounding to follow the United States Pharmacopeia-National Formulary (USP-NF) 797 standards for sterile compounding. Subsection R156-17b-310(8) identifies the factors that must be considered by the Utah State Board of Pharmacy, Utah Physicians Licensing Board and the Utah Osteopathic Physician and Surgeon's Licensing Board when determining if a drug may be dispensed by a physician.

State statutory or constitutional authorization for this rule:

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

Anticipated cost or savings to:

the state budget:

The Division will incur minimal costs of approximately $50 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. The proposed amendments allow physicians to dispense cosmetic or injectable weight loss drugs as defined in this rule. The legislation also granted authority to the Division to inspect physician offices should a complaint be made. This exemption or expanded scope of practice for a physician may lead to an increase in the number of complaints received by the Division. Given the new authority to inspect physicians' offices, the Division's investigators may be able to investigate a greater number of cases in a more in-depth manner. However, caseloads will need to be readjusted given there was no fiscal note and no additional monies provided to enforce the legislation.

local governments:

There should be little to no effect on local government. Local governments do not own or operate physician offices which may choose to dispense cosmetic or injectable weight loss drugs.

small businesses:

Currently physicians are not permitted to dispense prescription drugs. This proposed rule permits the dispensing, while requiring physicians who choose to dispense to follow the same dispensing standards required for pharmacists. A physician who elects to dispense the drugs listed in Subsections R156-17b-310(1) and R156-17b-310(2) may incur costs to store and label the drugs. There would also be a cost to implement a patient medication profile and patient counseling including the use of preprinted pharmacotherapeutic pamphlets for the drugs dispensed. Also, should a physician choose to dispense HCG, the powder must be reconstituted/compounded in accordance with the USP-NF 797 standards for sterile compounding. This could include the use of a laminar flow hood which costs approximately $10,000. Also, current studies indicate a short half-life for compounded HCG which will require more frequent visits to the physician's office for more medication at an additional cost to the patient and revenue for the physician. Exact estimates cannot be determined. However, because the dispensing of the drugs is a new permissible activity, the costs are elective.

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

It is possible, but not likely, that a pharmacy could have a negative fiscal impact if physicians begin to dispense the listed drugs. However, the drugs involved are limited and the physicians who specialize in treating the conditions which require the approved drugs are also limited. It is doubtful that a general practitioner is going to make the necessary changes required to dispense HCG, given it must be reconstituted in a sterile manner under a laminar flow hood.

Compliance costs for affected persons:

There would be a cost to a physician who chooses to dispense the listed drugs from his office. The costs most likely would be absorbed in the patient fee schedule. A physician who compounds HCG must follow the standards established in USP-NF 797 for sterile compounding which includes using a laminar flow hood when preparing sterile compounds. Exact estimates of costs cannot be determined due to a wide range of circumstances relating to physicians and their office settings.

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

This rule filing implements recent statutory amendments which exempt physicians and osteopathic physicians from the Pharmacy Practice Act for dispensing cosmetic drugs or injectable weight loss drugs. No fiscal impact to businesses results from this rule filing beyond that already addressed in the passage of the statutory amendments.

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:

• Laura Poe at the above address, by phone at 801-530-6789, by FAX at 801-530-6511, or by Internet E-mail at [email protected]

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:

10/15/2010

Interested persons may attend a public hearing regarding this rule:

• 09/28/2010 01:00 PM, Heber Wells Bldg, 160 E 300 S, Conference Room 474 (fourth floor), Salt Lake City, UT

This rule may become effective on:

10/22/2010

Authorized by:

Mark Steinagel, Director

R156. Commerce, Occupational and Professional Licensing.

R156-17b. Pharmacy Practice Act Rule.

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

(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 in accordance with Subsection 58-17b-309(1)(a) includes:

(a) 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 in accordance with Subsection 58-17b-309(1)(b) includes:

(a) human chorionic gonadotropin.

(3) In accordance with Subsection 58-17b-309(4)(c), a physician who chooses to dispense a cosmetic drug or injectable weight loss drug as listed in Subsections (1) and (2) to the physician'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 and dispensing the drug;

(b) the serial number of the prescription as assigned by the dispensing physician;

(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 who chooses to dispense a cosmetic drug or 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. 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 include:

(i) the physician 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 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 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 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 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 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 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 who dispenses a drug under Subsection (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 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 having access when the physician'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 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 when determining if a drug may be dispensed by a physician, 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 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 practitioner.

 

KEY: pharmacists, licensing, pharmacies

Date of Enactment or Last Substantive Amendment: [August 2, ]2010

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)