Title 201 | Chapter 002 | Regulation 076


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201 KAR 2:076.Compounding.

Section 1.

 

(1)

A policy and procedure manual for non-sterile and sterile compounding shall be readily available at a pharmacy for inspection purposes.

(2)

A copy of the manual shall be made available to the board upon request.

(3)

The manual shall be reviewed and revised on an annual basis.

Section 2.

 

(1)

All non-sterile compounded preparations shall be compounded pursuant to United States Pharmacopeia (USP) 795, unless specified portions submitted by a pharmacist have been waived by the board. Notwithstanding any USP guidance to the contrary, the addition of flavoring to a drug shall not be considered non-sterile compounding, if the additive:

(a)

Is inert, nonallergenic, and produces no effect other than the instillation or modification of flavor; and

(b)

Is not greater than five (5) percent of the drug product's total volume.

(2)

All sterile compounded preparations shall be compounded pursuant to USP 797, unless specified portions submitted by a pharmacist have been waived by the board.

(3)

All preparation, compounding, dispensing and repackaging of radiopharmaceuticals shall be pursuant to United States Pharmacopeia (USP) 825, unless specified portions submitted by a pharmacist have been waived by the board.

(4)

All written waiver requests submitted by a pharmacist shall be considered by the Board at its next regularly scheduled meeting.

(5)

The board, upon a showing of good cause and in balancing the best interest of the public health, safety, and welfare, may waive the requirement of any specified portion of USP 795, 797 or 825.

Section 3.

 

(1)

A facility that compounds non-sterile or sterile preparations shall be managed by a pharmacist-in-charge (PIC) licensed to practice pharmacy in the Commonwealth and who is knowledgeable in the specialized functions of preparing and dispensing compounded non-sterile and sterile preparations, including the principles of aseptic technique and quality assurance.

(2)

The PIC shall be responsible for the: purchasing, storage, compounding, repackaging, dispensing, distribution of all drugs and preparations, development and continuing review of all policies and procedures, training manuals, quality assurance programs, and participation in those aspects of the facility's patient care evaluation program relating to pharmaceutical material utilization and effectiveness.

(3)

The PIC may be assisted by additional pharmacy personnel adequately trained, to the satisfaction of the PIC, in this area of practice and for each product they will be compounding.

Section 4.

 

(1)

The pharmacist shall receive a written, electronic, facsimile, or verbal prescription, or medical order from a prescriber before dispensing any compounded, non-sterile or sterile preparation. These prescriptions or medical orders shall contain the following:

(a)

Patient's name and species, if not human;

(b)

Patient's address on controlled substances prescriptions or location (room number);

(c)

Drug name and strength;

(d)

Directions for use;

(e)

Date;

(f)

Authorized prescriber's name;

(g)

Prescriber's address and DEA number, if applicable;

(h)

Refill or end date instructions, if applicable; and

(i)

Dispensing quantity, if applicable.

(2)

A pharmacy generated patient profile shall be maintained separate from the prescription file. The patient profile shall be maintained under the control of the PIC for a period of two (2) years following the last dispensing activity. In addition, a medication administration record (MAR) as part of the institutional record shall be retained for a period of five (5) years from date of the patient's discharge from the facility, or in the case of a minor, three (3) years after the patient reaches the age of majority under state law, whichever is the longer. Supplemental records may also be employed as necessary. The patient profile shall contain:

(a)

Patient's name;

(b)

Name of compounded preparation dispensed;

(c)

Date dispensed;

(d)

Drug content and quantity; and

(e)

Patient's directions.

(3)

Each compounded preparation dispensed to patients shall be labeled with the following information:

(a)

Name, address, and telephone number of the licensed pharmacy, if product will leave the premises;

(b)

Date;

(c)

Identifying number;

(d)

Patient's full name;

(e)

Name of each drug, strength, and amount;

(f)

Directions for use, including infusion rate;

(g)

Required controlled substances transfer warnings, if applicable;

(h)

Beyond use date;

(i)

Identity of dispensing pharmacist;

(j)

Storage requirements, if applicable; and

(k)

Auxiliary labels, if applicable.

(4)

The PIC shall maintain access to and submit, as appropriate, these records and reports as are required to ensure the patient's health, safety, and welfare. Records shall be readily available, maintained for two (2) years at a facility not computerized, but for five (5) years at a facility utilizing computerized recordkeeping, and subject to inspection by the Board of Pharmacy or its agents. These shall include the following:

(a)

Patient profile;

(b)

Purchase records;

(c)

Biennial controlled substances inventories;

(d)

Policy and procedures manual;

(e)

Policies and procedures for hazardous wastes, if applicable;

(f)

Quality assurance records; and

(g)

Other records and reports as may be required by KRS 217 or 315 and 201 KAR Chapter 2.

(5)

Information regarding individual patients shall be maintained in a manner to assure confidentiality of the patient's records. Release of this information shall be in accordance with federal and state laws.

(6)

The PIC shall be responsible for the environmental control of all products shipped. Any compounded product that is frozen or requires refrigeration shall be shipped or delivered to a patient in appropriate temperature controlled delivery containers, if the product leaves the premises.

(7)

The PIC shall be responsible for assuring that there is a system for the disposal of hazardous waste in a manner that does not endanger the public health.

Section 5.

Hazardous Drugs.

(1)

All non-sterile preparations that contain hazardous substances shall be compounded pursuant to USP 795.

(2)

All sterile compounded preparations that contain hazardous substances shall be compounded pursuant to USP 797.

Section 6.

Violation of any provision of this administrative regulation shall constitute unethical or unprofessional conduct in accordance with KRS 315.121.

Section 7.

Incorporation by Reference.

(1)

The following material is incorporated by reference:

(a)

"USP 795, Revision Bulletin, Official" January 1, 2014;

(b)

"USP 797, Revision Bulletin, Official" June 1, 2008; and

(c)

"USP 825, Revision Bulletin, Official, Official" December 1, 2020.

(2)

This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. through 4:30 p.m. This material is also available on the board's Web site at https://pharmacy.ky.gov/statutesandregulations/Pages/default.aspx.

HISTORY: (16 Ky.R. 1716; Am. 2152; 2652; eff. 6-10-1990; 43 Ky.R. 2184; 44 Ky.R. 510; eff. 9-20-2017; 48 Ky.R. 879; 1726; eff. 12-15-2021.)

CONTACT PERSON: Larry Hadley, Executive Director, Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806, email Larry.Hadley@ky.gov.

7-Year Expiration: 12/15/2028

Last Action: 2/18/2022


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