Iowa Admin. Code r. 657-100.3

Current through Register Vol. 47, No. 11, December 11, 2024

Rule 657-100.3 - Electronic pseudoephedrine tracking system (PTS)

Unless granted an exemption by the office pursuant to these rules, all pharmacies dispensing products as defined in rule 657-100.2 (124) without a prescription are required to participate in the PTS pursuant to Iowa Code section 124.212B.

(1)Reporting elements. The record of a completed purchase or attempted purchase of a product without a prescription shall contain the following:

a. The name and address of the purchaser.

b. A current government-issued photo identification number.

c. The electronic signature of the purchaser. If a pharmacy is not able to secure or record an electronic signature, a hard-copy signature logbook shall be utilized and maintained by the pharmacy. Each record in the logbook shall include the purchaser's signature and shall identify the purchase by transaction number.

d. Date and time of purchase.

e. The name and quantity of the product purchased, including the total milligrams of ephedrine, pseudoephedrine, or phenylpropanolamine contained in the product.

f. The name or unique identification of the dispenser who approved the dispensing of the product.

(2)Frequency and quantity. Dispensing at retail to the same purchaser within any 30-day period shall be limited to products collectively containing no more than 7,500 mg of ephedrine, pseudoephedrine, or phenylpropanolamine; dispensing at retail to the same purchaser within a single calendar day shall not exceed 3,600 mg.

(3)Denial of transactions and overrides.

a. If an individual attempts to purchase a product in violation of these rules, the PTS shall:

(1) Notify the dispenser at the time of sale; and

(2) Recommend that the dispenser deny the transaction.

b. The PTS shall provide an override feature for use by a dispenser to allow completion of the sale. A dispenser utilizing the override feature shall document the reason that, in the professional judgment of the dispenser, it is necessary to override the recommendation of the PTS to deny the transaction.

(4)Availability of electronic PTS. If the electronic PTS is unavailable for use, the dispenser shall maintain a written record of each transaction pursuant to 657-subrule 10.34(6). The dispenser shall enter the information from the written record into the PTS within 72 hours of the time the PTS is again available and shall include in the electronic record that the record is a delayed entry.

Iowa Admin. Code r. 657-100.3

ARC 8893B, IAB 6/30/10, effective 9/1/10; ARC 0153C, IAB 6/13/12, effective 7/18/12

Amended by IAB June 7, 2017/Volume XXXIX, Number 25, effective 7/12/2017

Amended by IAB September 27, 2017/Volume XL, Number 7, effective 11/1/2017

Amended by IAB October 9, 2019/Volume XLII, Number 8, effective 11/13/2019