Section 338.479b. Noncontrolled prescriptions.

b. (1) A prescriber who issues a prescription for a noncontrolled legend drug shall date the prescription; provide a manual signature on the prescription, as defined in R 338.471a(f) of these rules; and ensure that the prescription contains all of the following information:

(a)   The full name of the patient for whom the drug is being prescribed.

(b)   The prescriber’s printed name and address.

(c)   The drug name and strength.

(d)  The quantity prescribed.

(e)   The directions for use.

(f)  ) The number of refills authorized.

(2)   A prescriber shall ensure that a prescription is legible and that the information specified in subrule (1)(c) to (f) of this rule is clearly separated.

(3)   A prescriber shall not prescribe more than either of the following on a single prescription form as applicable:

(a)       For a prescription prescribed in handwritten form, up to 4 prescription drug orders.

(b)     For a prescription prescribed on a computer-generated form or a preprinted list or produced on a personal computer or typewriter, up to 6 prescription drug orders.

(4)   A prescription is valid for 1 year from the date the prescription was issued.

(5)   A noncontrolled substance prescription may be transmitted electronically from the prescriber to the pharmacy of the patient’s choice, and shall occur by utilizing a system that includes the following:

(a)   A combination of technical security measures such as, but not limited to, those listed in R 164.312 under Subpart C – Security Standards for the Protection of Electronic Protected Health Information of 45 CFR Part 164 that implements the federal health insurance portability and accountability act of 1996, to ensure all of the following:

(i)   Authentication of an individual who prescribes or dispenses.

(ii)   Technical non-repudiation.

(iii)   Content integrity.

(iv)   Confidentiality.

(b)   An electronic signature as defined in R 338.471a(e). An electronic signature is valid when it is used to sign a noncontrolled prescription.

(c)   Appropriate security measures to invalidate a prescription if either the electronic signature or prescription record to which it is attached or logically associated is altered or compromised following transmission by the prescriber. The electronic prescription may be reformatted to comply with industry standards provided that no data is added, deleted, or changed.

(6)    The electronic prescription shall meet any other requirements of the federal health insurance portability and accountability act.

(7)   The electronic prescription shall permit the prescriber to instruct the pharmacist to dispense a brand name drug product provided that the prescription includes both of the following:

(i)    The indication that no substitute is allowed, such as “dispense as written” or “DAW”.

(ii)   The indication that no substitute is allowed and that it is a unique element in the prescription.

(8)   If the prescription is transmitted electronically, the prescriber shall generate and transmit the prescription in a format that can be read and stored by a pharmacy in a retrievable and readable form. The electronic prescription shall identify the name of the pharmacy intended to receive the transmission, and shall include the information identified in subrule (1) of this rule.

(9)     The electronic prescription shall be preserved by a licensee or dispensing prescriber for not less than 5 years. A paper version of the electronic prescription shall be made available to an authorized agent of the board upon request. A secured copy shall be retained for a minimum of 1 year by the transaction service vendor for record-keeping purposes and shall be shared only with the parties involved in the transaction except as otherwise permitted by state or federal law.

(10)   An electronic signature that meets the requirements of this rule shall have the full force and effect of a handwritten signature on a paper-based written prescription.

(11)      A pharmacy shall keep the original prescription record for 5 years. After 3 years, a pharmacy may make an electronic duplicate of the original paper prescription, which shall become the original prescription. A pharmacy shall present a paper copy of the electronic duplicate of the prescription to an authorized agent of the board upon request.

(12)  This rule does not apply to inpatient medical institutions. History:  1998-2000 AACS; 2000 AACS; 2007 AACS; 2013 AACS.