INACTIVE

This document is no longer current.

BOARDS AND COMMISSIONS

Board of Pharmacy

(New Administrative Regulation)

201 KAR 2:311.Compounding for a practitioner's office or institutional administration.

RELATES TO:

KRS 315.191(1)(a).

STATUTORY AUTHORITY:

KRS 315.191(1)(a)

NECESSITY, FUNCTION, AND CONFORMITY:

KRS 315.191(1)(a) requires the board to promulgate administrative regulations to regulate and control all matters relating to pharmacists, pharmacist interns, pharmacy technicians, and pharmacies. This administrative regulation addresses compounding for use by a practitioner's office administration or institutional administration.

Section 1.

A pharmacist, pharmacist intern, or pharmacy technician may prepare a compounded drug for a practitioner's office administration or institutional administration.

Section 2.

A compounded drug that contains a controlled substance shall not be compounded for office or institutional administration.

Section 3.

The pharmacist shall receive a written, verbal, facsimile, or electronic request for a compounded drug from a practitioner, indicating the formulation, strength, and quantity ordered.

Section 4.

Label Requirements. A label shall be generated for the compounded drug and shall include:

(1)

The name of the practitioner;

(2)

The designated name and strength of the compounded drug;

(3)

The quantity dispensed;

(4)

A lot or batch number of the compounded drug;

(5)

The beyond use date for the compounded drug;

(6)

The date the compounded is dispensed;

(7)

The pharmacy's name, address, and telephone number;

(8)

Any special storage requirements;

(9)

A notation stating "For Office or Institutional Administration Only-Do Not Dispense to Patient;

(10)

Any auxiliary label required for the compounded drug.

Section 5.

The compounded drug shall be administered in the practitioner's office or institution and shall not be dispensed to the patient.

Section 6.

The prescription for the compounded drug shall be kept pursuant to 201 KAR 2:170.

NAME, Title

APPROVED BY AGENCY: Date

PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall be held on Month ##, 2020, at time, at location of the meeting. Individuals interested in being heard at this hearing shall notify this agency in writing by five workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing was received by that date, the hearing may be cancelled. A transcript of his hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on the proposed administrative regulation. Written comments shall be accepted until Month ##, 2020. Send written notification of intent to be heard at the public hearing or written comments on the proposed administrative regulation to the contact person.

CONTACT PERSON: Name, title, full address, phone, fax, and email for the contact.

REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT

Contact Person:

(1) Provide a brief summary of:

(a) What this administrative regulation does:

(b) The necessity of this administrative regulation:

(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:

(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:

(a) How the amendment will change this existing administrative regulation:

(b) The necessity of the amendment to this administrative regulation:

(d) How the amendment will assist in the effective administration of the statues:

(d) How the amendment will assist in the effective administration of the statutes:

(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:

(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:

(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:

(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):

(5) Provide an estimate of how much it will cost to implement this administrative regulation:

(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:

(a) Initially:

(b) On a continuing basis:

(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:

(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change, if it is an amendment: (8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:

(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:

(8) State whether or not this administrative regulation established any fees or directly or indirectly increased any fees:

(9) TIERING: Is tiering applied?

Explain why tiering was or was not used.

FISCAL NOTE ON STATE OR LOCAL GOVERNMENT

(1) What units, parts or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation?

(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.

(3) Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.

(a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year?

(b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years?

(d) How much will it cost to administer this program for subsequent years?

Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.

Revenues (+/-):

Expenditures (+/-):

Other Explanation: