902 KAR 55:105. Controlled substance prescription blanks.

 

      RELATES TO: KRS 218A.030-218A.140, 218A.204, 218A.170-218A.240, 218A.281, 218A.282, 218A.284, 218A.286, 218A.288

      STATUTORY AUTHORITY: KRS 194A.030, 194A.050, 211.090, 218A.204, 218A.250

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.204 requires the cabinet to promulgate administrative regulations that establish security requirements for a prescription blank used by a practitioner to write a prescription for a controlled substance. The purpose of this administrative regulation is to establish minimum requirements that will decrease the potential for forgery or alteration of a prescription or a prescription blank for a controlled substance.

 

      Section 1. Definitions. (1) "Logo" means a symbol utilized by an individual, a pharmacy, professional practice, professional association, or hospital.

      (2) "Security prescription blank" means a prescription blank that complies with the requirements of Section 3 of this administrative regulation.

 

      Section 2. Security Prescription Blanks Required. (1) Beginning January 1, 1999, a written prescription for a controlled substance shall be on a security prescription blank unless, pursuant to Section 7 of this administrative regulation, the cabinet has granted a waiver to the practitioner who wrote the prescription or to the pharmacy that dispenses it.

      (2) A practitioner who is licensed in Kentucky and in another state shall utilize a security prescription blank for writing a prescription for a controlled substance while practicing his profession within the Commonwealth unless, pursuant to Section 7 of this administrative regulation, the cabinet has granted a waiver to the practitioner or to the pharmacy that dispenses the controlled substance.

 

      Section 3. Requirements of a Security Prescription Blank. (1) A prescription for a controlled substance shall contain the following security features:

      (a) A latent, repetitive "void" pattern screened at five (5) percent in pantone green shall be printed across the entire front of the prescription blank. If a prescription is photocopied, the word "void" shall appear in a pattern across the entire front of the prescription;

      (b) A watermark shall be printed on the backside of the prescription blank so that it shall only be seen at a forty-five (45) degree angle. The watermark shall consist of the words "Kentucky Security Prescription", and appear horizontally in a step-and-repeated format in five (5) lines on the back of the prescription using twelve (12) point Helvetica bold type style;

      (c) An opaque ] symbol shall appear in the upper right-hand corner, one-eighth (1/8) of an inch from the top of the prescription blank and five-sixteenths (5/16) of an inch from the right side of the prescription blank. The symbol shall be three-fourths (3/4) of an inch in size and disappear if the prescription copy is lightened;

      (d) Six (6) quantity check off boxes shall be printed on the form and the following quantities shall appear:

      1. o 1–24;

      2. o 25–49;

      3. o 50-74;

      4. o 75-100;

      5. o 101-150;

      6. o 151 and over;

      (e) A logo may appear on the prescription blank. The upper left one (1) inch square of the prescription blank shall be reserved for a logo;

      (f) The following statement shall be printed on the bottom of the prescription blank: "Prescription is void if more than one (1) prescription is written per blank";

      (g) Refill options shall appear below any logo on the left side of the prescription blank in the following order: Refill NR 1 2 3 4 5; and

      (h) A prescription blank shall be four and one-quarter (41/4) inches high and five and one-half (51/2) inches wide.

      (2) A prescription shall bear the preprinted, stamped, typed, or manually printed name, address and telephone number of the prescribing practitioner.

      (3) A prescription blank for a controlled substance shall not contain:

      (a) An advertisement on the front or the back of the prescription blank;

      (b) The preprinted name of a controlled substance; or

      (c) The written, typed, or rubber-stamped name of a controlled substance until the prescription blank is signed, dated and issued to a patient.

      (4) A prescription blank for a controlled substance shall provide space for the patient's name and address, the practitioner's signature and the practitioner's DEA registration number.

 

      Section 4. Other Requirements. (1) Only one (1) prescription shall be written per prescription blank.

      (2) A quantity check-off box that corresponds to the quantity prescribed shall be marked.

      (3) If a prescribed drug is a schedule III, IV or V controlled substance, a refill option shall be marked.

      (4) If a prescription for a schedule III, IV, or V controlled substance will be transmitted to a pharmacy by facsimile, the practitioner or the practitioner's agent shall, prior to transmission, write or stamp "FAXED" on the face of the original prescription along with the date and the person's initials.

      (5) If a pharmacist uses due diligence in ascertaining the validity of a prescription, a prescription for a schedule III, IV, or V controlled substance that is transmitted to a pharmacy by facsimile shall be exempt from the requirement of green ink in Section 3(1)(a) of this administrative regulation and the requirement of a watermark in Section 3(1)(b) of this administrative regulation.

      (6) If a prescription for a schedule III, IV or V controlled substance has been transmitted to a pharmacy by facsimile, the transmitting practitioner shall file the original prescription in the patient’s record.

 

      Section 5. Exceptions. A pharmacist shall not be required to use a security prescription blank to record an oral prescription or a transferred prescription for a Schedule III, IV, or V controlled substance.

 

      Section 6. Printers, Reproducers or Distributors of Security Prescription Blanks. (1) A printer, reproducer or distributor of security prescription blanks shall require a written purchase order or request for security prescription blanks. A written purchase order or request shall remain on file for two (2) years.

      (2) A purchase order or request shall be signed by:

      (a) A practitioner whose name shall be printed on the security prescription blanks; or

      (b) The chief medical official of a health care facility or pharmacist-in-charge of a pharmacy, if the security prescription blanks are requested on behalf of a practitioner who stamps, types or manually prints his name, address, telephone number and DEA number on the security prescription blank.

      (3) The provisions of this section shall not apply to distributions between printers, reproducers, or distributors.

 

      Section 7. Waiver of Security Prescription Blanks. (1) A practitioner or a pharmacy may apply in writing to the cabinet for a waiver from the requirement for security prescription blanks. A request for a waiver shall include:

      (a) A detailed statement of the security features provided by the system proposed by the applicant for the prevention of forgery or alteration of an original prescription; or

      (b) The format of the alternative prescription blank.

      (2) The system or prescription blank proposed by the applicant shall provide a level of security equivalent to a security prescription blank.

      (3) The cabinet shall grant or deny the application in writing within sixty (60) days after the request is received.

      (4) When a waiver has been granted, the cabinet may suspend or revoke the waiver if the alternative system or alternative prescription blank does not provide security equivalent to a security prescription blank.

      (5) Upon notification of denial, suspension, or revocation of the waiver of the requirement for a security prescription blank, the practitioner or pharmacy may request a hearing. The administrative hearing shall be conducted in accordance with 902 KAR 1:400. (25 Ky.R. 721; Am. 1074; 1366; eff. 12-16-98.)