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Rulemaking Published

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Rulemaking action by the Iowa Board of Pharmacy has been published in the Iowa Administrative Bulletin as follows: 

Notice of Intended Action

ARC 5365C has been published as a Notice of Intended Action to amend Chapter 10, “Controlled Substances”

  • The proposed amendments temporarily add two substances to the Iowa Controlled Substances Act (CSA) in response to similar scheduling action taken by the DEA.

  • Comments may be submitted no later than 4:30pm on January 19, 2021 through the link above.

ARC 5369C has been published as a Notice of Intended Action to amend Chapter 37, “Iowa Prescription Monitoring Program”

  • The proposed amendments:

    • implement changes made to Iowa Code during the 2020 legislative session, including the reporting of schedule V controlled substances to the database and veterinarian access to program data, and 

    • propose to amend the definition of “health care professional” and add new definitions for “client” and “patient”.

  • Comments may be submitted no later than 4:30pm on January 19, 2021 through the link above.

Adopted

ARC 5346C is rulemaking which has been adopted and amends Chapter 10, “Controlled Substances”

  • The amendments:

    • Temporarily place into the Iowa CSA five substances (one fentanyl precursor into CII, an FDA-approved treatment for insomnia in CIV, an FDA-approved treatment for seizures into CV, and two chemicals used in the manufacture of illicit fentanyl as precursor substances),

    • Remove the names of prior substances temporarily scheduled by rule in response to the permanent scheduling of those substances by 2020 Iowa Acts, Senate File 2119, 

    • Amend subrule 10.38(3) to incorporate updated language from 2020 Iowa Acts, Senate File 2119, and 

    • Rescind paragraph 10.30(2)”g” in response to 2020 Iowa Acts, Senate File 2357, section 1, which removes the requirement that the name of a supervising physician be included on a prescription issued by a physician assistant.

  • The rules will be effective February 3, 2021.

ARC 5347C is rulemaking which has been adopted and amends Chapter 10, “Controlled Substances”

  • The amendments:

    • Add one synthetic opioid to CI and

    • Remove from the CSA FDA-approved cannabidiol products containing less than 0.1 percent tetrahydrocannabinol (THC). 

  • The rules will be effective February 3, 2021.

ARC 5348C is rulemaking which has been adopted and amends Chapter 1, “Purpose and Organization,” Chapter 2, “Pharmacist Licenses,” Chapter 8, “Universal Practice Standards,” Chapter 13, “Telepharmacy Practice,” Chapter 16, “Nuclear Pharmacy Practice,” Chapter 26, “Petitions for Rule Making,” Chapter 34, “Rules for Waivers and Variances,” and Chapter 39, “Expanded Practice Standards”

  • The amendments implement changes made to Iowa Code during the 2019 and 2020 legislative sessions and include:

    • Oversight of the board’s executive director,

    • Service animals or service-animals-in-training,

    • Extension of the future repeal date for physician-signed immunization protocols (to now expire June 30, 2021),

    • Waivers and variances, and

    • Submission of the disposition of a petition for rulemaking to the administrative rules review committee.

  • The rules will be effective February 3, 2021.

ARC 5349C is rulemaking which has been adopted and amends Chapter 10, “Controlled Substances” and Chapter 11, “Drugs in Emergency Medical Service Programs”

  • The amendments:

    • Clarify the board’s expectation that a registrant’s perpetual inventory at all times accurately reflects the actual on-hand inventory of the substances,

    • Simplify the rule relating to the purchase of schedule I or II controlled substances (in response to DEA implementation of the new single-sheet DEA Form 222).

  • The rules will be effective February 3, 2021.

ARC 5350C is rulemaking which has been adopted and amends Chapter 8, “Universal Practice Standards” and Chapter 21, “Electronic Data and Automated Systems in Pharmacy Practice”

  • The amendments:

    • Clarify that patient information which is needed for a pharmacist to conduct a drug utilization review shall be obtained and that collection of the information can be delegated to a pharmacy technician, 

    • Require an electronically-submitted prescription must include the telephone number where the prescriber can be contacted, and

    • Update a reference.

  • The rules will be effective February 3, 2021.

ARC 5351C is rulemaking which has been adopted and amends Chapter 17, “Wholesale Distributor Licenses” and Chapter 43, “Third-Party Logistics Provider Licenses”

  • The amendments:

    • Update the name of the NABP drug distributor accreditation program and

    • Update accreditation provider options for entities involved in the drug supply chain (wholesale distributors and third-party logistics providers) to include the following accreditation providers:

      • NABP Drug Distributor Accreditation,

      • NCDQS Quality and Security Accreditation, or

      • Another accreditation program approved by the board.

  • The rules will be effective February 3, 2021.

ARC 5352C is rulemaking which has been adopted and amends Chapter 16, “Nuclear Pharmacy Practice”

  • The amendment requires nuclear pharmacies to comply with the standards identified in USP General Chapter 825 which became official December 1, 2020.

  • The rule will be effective February 3, 2021.