Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS 218A.030-218A.140,
218A.204,
218A.170-218A.240,
218A.281,
218A.282,
218A.284,
218A.286,
218A.288
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 Rx 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. D 1-24;
2. D 25-49;
3. D 50-74;
4. 0 75-100;
5. D 101-150;
6. D 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 (4 1/4) inches high and five and one-half (5 1/2) 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.
STATUTORY AUTHORITY:
KRS
194A.030,
194A.050,
211.090,
218A.204,
218A.250