Section 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 2009 Iowa Code Supplement section 124.212B. The office has established a council to provide input and advise the office regarding the implementation, maintenance, and administration of the PTS. The council also assists the office in developing guidelines to ensure patient confidentiality and the integrity of the relationship established by the patient and the patient’s health care provider.

       100.3(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 pharmacist or pharmacist-intern who approved the dispensing of the product.

       100.3(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.

       100.3(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. For security purposes and to ensure the integrity of the PTS, use of the override feature shall be restricted to authorized dispensers and may not be delegated to a pharmacy technician or a pharmacy support person. 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.

       100.3(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 10.32(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.

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