A product containing ephedrine, pseudoephedrine, or
phenylpropanolamine, which substance is a Schedule V controlled substance and
is not listed in another controlled substance schedule, may be dispensed or
administered without a prescription by an authorized dispenser pursuant to
657-Chapter 100 to a purchaser at retail pursuant to the conditions of this
rule.
(1)
Who may
dispense. Dispensing shall be by an authorized dispenser pursuant to
657-Chapter 100. This subrule does not prohibit, after the dispenser has
fulfilled the professional and legal responsibilities set forth in this rule
and has authorized the dispensing of the substance, the completion of the
actual cash or credit transaction or the delivery of the substance by another
pharmacy employee.
(2)
Packaging of nonliquid forms. A nonliquid form of a product
containing ephedrine, pseudoephedrine, or phenylpropanolamine includes gel
caps. Nonliquid forms of these products to be sold pursuant to this rule shall
be packaged either in blister packaging with each blister containing no more
than two dosage units or, if blister packs are technically infeasible, in unit
dose packets or pouches.
(3)
Frequency and quantity. Dispensing without a prescription 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 without a prescription to the same purchaser
within a single calendar day shall not exceed 3,600 mg.
(4)
Age of purchaser. The
purchaser shall be at least 18 years of age.
(5)
Identification. The
dispenser shall require every purchaser under this rule to present a current
government-issued photo identification, including proof of age when
appropriate. The dispenser shall be responsible for verifying that the name on
the identification matches the name provided by the purchaser and that the
photo image depicts the purchaser.
(6)
Record. Purchase records
shall be recorded in the real-time electronic pseudoephedrine tracking system
(PTS) established and administered by the governor's office of drug control
policy pursuant to 657-Chapter 100. If the PTS is unavailable for use, the
purchase record shall be recorded in an alternate format and submitted to the
PTS as provided in 657-subrule 100.3(4).
a.
Alternate record contents. The alternate record shall contain
the following:
(1) The name, address, and
signature of the purchaser.
(2) The
name and quantity of the product purchased, including the total milligrams of
ephedrine, pseudoephedrine, or phenylpropanolamine contained in the
product.
(3) The date and time of
the purchase.
(4) The name or
unique identification of the dispenser who approved the dispensing of the
product.
b.
Alternate record format. The record shall be maintained using
one of the following options:
(1) A hard-copy
record.
(2) A record in the
pharmacy's electronic prescription dispensing record-keeping system that is
capable of producing a hard-copy printout of a record.
(3) A record in an electronic data collection
system that captures each of the data elements required by this subrule and
that is capable of producing a hard-copy printout of a record.
c.
PTS records
retrieval. Pursuant to 657-subrule 100.4(6), the pharmacy shall be
able to produce a hard-copy printout of transactions recorded in the PTS by the
pharmacy for one or more specific products for a specified period of time upon
request by the board or its representative or to such other persons or
governmental agencies authorized by law to receive such information.
(7)
Notice
required. The pharmacy shall ensure that the following notice is
provided to purchasers of ephedrine, pseudoephedrine, or phenylpropanolamine
products and that the notice is displayed with or on the electronic signature
device or is displayed in the dispensing area and visible to the public:
"Warning: Section 1001 of Title 18, United States Code, states
that whoever, with respect to the logbook, knowingly and willfully falsifies,
conceals, or covers up by any trick, scheme, or device a material fact, or
makes any materially false, fictitious, or fraudulent statement or
representation, or makes or uses any false writing or document knowing the same
to contain any materially false, fictitious, or fraudulent statement or entry,
shall be fined not more than $250,000 if an individual or $500,000 if an
organization, imprisoned not more than five years, or both."
Notes
Iowa Admin. Code
r. 657-10.34
ARC 3345C, IAB
9/27/17, effective 11/1/17; ARC
4701C, IAB 10/9/19, effective 11/13/19
ARC 8539B, IAB 2/24/10,
effective 4/1/10
Amended by
IAB
February 17, 2016/Volume XXXVIII, Number 17, effective
3/23/2016
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
Rescinded by
IAB
June 11, 2025/Volume XLVII, Number 25, effective
7/16/2025
