Kan. Admin. Regs. § 68-7-18 - Health departments and private not-for-profit family planning clinics

The distribution and control of drugs provided by health departments and private not-for-profit family planning clinics authorized under K.S.A. 65-1648(d)(1), and amendments thereto, shall conform to the following requirements:

(a) The approved drugs that may be stored and distributed by health departments and not-for-profit family planning clinics shall be only noncontrolled drugs that are approved by the food and drug administration. In determining the formulary for each health department or not-for-profit family planning clinic, the pharmacist-in-charge shall consult with the medical supervisor and director of nursing for that facility. No state or federal controlled drugs shall be allowed.

(b)

(1) The pharmacist-in-charge shall review the procedures outlined below for the distribution and control of all drugs within health department facilities and family planning clinics and shall be responsible for the following:

(A) Ensuring the development of programs for supervision of all personnel in the distribution and control of drugs;

(B) ensuring the development of a policy and procedure manual governing the storage, control, and distribution of drugs;

(C) maintaining documentation of at least quarterly checks of drug records, drug storage conditions, and drugs stored in all locations within the facility;

(D) establishing a drug recall procedure that can be effectively implemented; and

(E) ensuring the development of written procedures for maintaining records of distribution and prepackaging of drugs.

(2) Labels for prepackaged drugs shall contain the following:

(A) The brand name or corresponding generic name of the drug;

(B) the name of the manufacturer or distributor of the drug, or an easily identified abbreviation of the manufacturer's or distributor's name;

(C) the strength of the drug;

(D) the contents in terms of weight, measure, or numerical count;

(E) the lot number of the drug, if the lot number is not recorded on a suitable log; and

(F) the beyond-use date of the drug.

(3) Prepackaged drugs shall be packaged in suitable containers and shall be subject to all other provisions of the Kansas state board of pharmacy regulations under the uniform controlled substances act of the state of Kansas and under the pharmacy act of the state of Kansas.

(c) The procedures for the control and distribution of drugs within health department facilities and family planning clinics shall be consistent with the following requirements:

(1) Adequate records of the distribution of drugs by the designated registered professional nurse or nurses shall be maintained and shall include the physician's order or written protocol.

(A) If the physician's order was given orally, electronically, or by telephone, the designated registered professional nurse or nurses shall reduce that order to writing. The written copy of the order shall be signed by the designated registered professional nurse and maintained in a permanent patient file.

(B) The records shall include the following:

(i) The full name of the patient;

(ii) the date supplied;

(iii) the name of the drug, the quantity supplied, and strength of the drug distributed;

(iv) the directions for use;

(v) the prescriber's name. The record shall include the name of the practitioner and, if involved, the name of either the physician's assistant (PA) or the advanced registered nurse practitioner (ARNP);

(vi) the expiration date of the drug; and

(vii) the lot number of the drug.

(2) A supply of drugs shall be provided to a patient by a designated registered professional nurse or nurses pursuant to a prescriber's order. Only a designated registered professional nurse or nurses may access the pharmacy area and remove the supply of the drugs. The supply shall conform with the following labeling requirements:

(A) The name, address, and telephone number of the health department or family planning clinic from which the drug is supplied;

(B) the full name of the patient;

(C) adequate directions for use of the drug;

(D) the name of the prescriber. The label shall include the name of the practitioner and, if involved, the name of either the physician's assistant (PA) or the advanced registered nurse practitioner (ARNP);

(E) the date the supply was distributed;

(F) the identification number assigned to the supply of the drug distributed by the health department or family planning clinic;

(G) the brand name or corresponding generic name of the drug;

(H) necessary auxiliary labels and storage instructions, if needed; and

(I) the beyond-use date of the drug issued.

(3) Repackaged drugs shall be packaged in suitable containers and shall be subject to all other provisions of the Kansas state board of pharmacy rules and regulations under the pharmacy act of the state of Kansas.

(d) The appointment of any Kansas licensed pharmacist as pharmacist-in-charge of a health department or family planning clinic shall be subject to the provisions of K.A.R. 68-1-2a and 68-7-13.

Notes

Kan. Admin. Regs. § 68-7-18

Authorized by and implementing K.S.A. 65-1648; effective, T-84-3, Feb. 10, 1983; effective May 1, 1984; amended July 23, 1999; amended April 28, 2000.