COVID-19 Information and Updates

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Information about Ordering and Administering COVID-19 Therapeutics by Pharmacies (Updated July 7, 2022)

On September 13, 2021, HHS published a 9th Amendment to its PREP Act Declaration. In this amendment, HHS authorized qualified pharmacists to order and administer COVID-19 therapeutics which have been approved or authorized by FDA which are administered orally, intramuscularly, or subcutaneously. The amendment also authorized qualified pharmacy interns and technicians to administer COVID-19 therapeutics. The HHS authorization requires a pharmacist to be readily and immediately available to any qualified technician administering COVID-19 therapeutics. Individuals who will be administering therapeutics via intramuscular or subcutaneous routes must hold current CPR certification and complete an ACPE-approved practical training program which includes:

  • Hands-on injection technique,
  • Clinical evaluation of indications and contraindications of COVID-19 therapeutics,
  • Recognition and treatment of emergency reactions to COVID-19 therapeutics, and 
  • Any additional training required by FDA.

Following the ordering and administration of a COVID-19 therapeutic, pursuant to the PREP Act, subsection 2,  the pharmacy must maintain documentation of the order/administration and notify the patient’s primary care provider. 

The Board previously issued Guidance on September 17, 2021 which provided information relating to pharmacist authority to order and administer REGEN-COV under Emergency Use Authorization administered subcutaneously. On January 24, 2022, the federal Food and Drug Administration updated the EUA Fact Sheets for bamlanivimab/etesevimab and REGEN-COV.

FDA now says these two treatments are not currently authorized for use anywhere in the U.S., due to the prevalence of Omicron. 

The FDA has subsequently issued Emergency Use Authorization for the following COVID-19 therapeutics: 

  • EVUSHELD EAU (long-acting monoclonal antibody), updated May 17, 2022, for pre-exposure prophylaxis, administered intramuscularly
  • PAXLOVID EAU (anti-viral), updated July 6, 2022, for treatment of mild to moderate COVID-19, administered orally
  • Molnupiravir EAU (anti-viral), updated March 23, 2022 for treatment of mild to moderate COVID-19, administered orally

It is important to note that the approved Fact Sheets for health care providers for EVUSHELD (updated June 29, 2022) and Molnupiravir (updated June 1, 2022)  specifically identify that these medications may only be prescribed or ordered by a physician, advanced registered nurse practitioner, or physician’s assistant who is licensed to prescribe the respective category of medications. As such, a pharmacist is not authorized under the EUAs or PREP Act to order these medications. A pharmacy which has been allocated supplies of these therapeutics may dispense the products pursuant to a patient-specific prescription issued by a licensed practitioner who is authorized to prescribe the medication.

On July 6, 2022, FDA’s update to the EUA for PAXLOVID added authorization for state-licensed pharmacists to prescribe PAXLOVID to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of the drug. Before a pharmacist is authorized to prescribe PAXLOVID to an eligible patient, the pharmacist must have access to sufficient patient records to assess the patient’s renal and hepatic function as well as to assess for potential drug interactions. Such patient records can be provided by the patient (electronic or printed health records less than 12 months old) or via consultation with the patient’s health care provider. Pharmacists should review the Fact Sheet for Providers (updated July 5, 2022) prior to engaging in the prescribing of PAXLOVID.

Due to the  limited supply of products being allocated to the state from the federal government, distribution of these COVID-19 therapeutics to providers, including pharmacies, is also extremely limited. As state allocations of therapeutics are increased to a level warranting expanded pharmacy partner distribution, more information will be provided here.

Map of providers which have been allocated therapeutic products

Subscribe to the IDPH weekly therapeutics information brief

Additional information can be found on the IDPH COVID-19 Therapeutics webpage, including a helpful COVID-19 Therapeutics Table.

COVID-19 Vaccine Administration and Testing in Pharmacies

On February 3, 2022, Governor Reynolds signed the final extension of the state’s Public Health Disaster Emergency Proclamation, announcing its expiration at 11:59 p.m. on Tuesday, February 15, 2022.  The signed proclamation can be found here.  

What does this mean for pharmacy administration of COVID-19 vaccines? Currently, COVID-19 vaccine administration authority for pharmacies originates from three separate and distinct pathways:

At the conclusion of the state’s Public Health Disaster Emergency Proclamation, all three vaccine authority pathways will continue to exist. The “Legal Authority” section of the Statewide Standing Order may be updated, but the underlying authority for pharmacists to vaccinate under the Statewide Standing Order will remain. 

The Department of Public Health has indicated that, at some point in the future, the Statewide Standing Order for vaccine administration will be discontinued. At that point, pharmacists will need to act as the authorizing provider (either under the Board’s Statewide Protocol or the PREP Act) to continue providing COVID-19 vaccines. To prepare for this eventuality, and to ensure continuity of third-party billing, please consider completing the following as soon as possible:

  • Obtain a National Provider Identifier
  • Enroll in Iowa Medicaid as a provider (to continue offering vaccines to Medicaid recipients),
  • Once enrolled with Iowa Medicaid, complete the credentialing process with the Managed Care Organizations

What does this mean for pharmacy administration of COVID-19 tests? Currently, COVID-19 testing authority for pharmacies originates from two separate and distinct pathways:

At the conclusion of the state’s Public Health Disaster Emergency Proclamation, both testing authority pathways will continue to exist. The “Legal Authority” section of the Statewide Standing Order may be updated, but the underlying authority for pharmacists to authorize tests under the Statewide Standing Order will remain. However, state reporting requirements will be augmented and pharmacies will no longer be required to report negative COVID-19 test results to the state. Please keep in mind that this does not relieve pharmacies of any federal reporting requirements associated with administering COVID-19 tests,, if applicable. 

Board issues Frequently Asked Questions: COVID-19

The Board has received a number of questions from pharmacies and practitioners about responding to coronavirus-related difficulties. To aid pharmacies and practitioners, the Board has issued a Frequently Asked Questions: COVID-19 (updated March 3, 2022). This document will continue to be updated as warranted and licensees are encouraged to continue to check back to this site for updated information.

Board issues Guidance for Non-Resident Pharmacists and Pharmacist-Interns to Administer Immunizations in Iowa

On January 28, 2021, the United States Health and Human Services (HHS) issued its 5th amendment to the PREP Act. The amendment adds to the list of covered persons immune from liability for providing COVID countermeasures. The amendment:

  • Authorizes any healthcare provider who is licensed or certified in a state to prescribe, dispense, and/or administer COVID-19 vaccines in any other state or U.S. territory, so long as the license or certification has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of the Inspector General.
  • Authorizes any physician, registered nurse, or practical nurse whose license or certification expired within the past five years to prescribe, dispense and/or administer COVID-19 vaccines in any state or U.S. territory so long as the license or certification was active and in good standing prior to the date it went inactive.
  • Requires any healthcare professional described above to complete Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Training and, for healthcare providers who are not currently practicing or whose license or certification is expired, requires an on-site, documented observation period by a currently practicing healthcare professional.

The Board recognizes the preemption of the HHS Declaration to state law which otherwise requires a pharmacist or pharmacist-intern to hold an active Iowa license or registration prior to engaging vaccine administration.  Pharmacist-Interns who wish to engage in immunization activities in Iowa are allowed to engage in the activity so long as they meet the HHS requirements as identified in the Declaration and are under the supervision of an authorized pharmacist.