Oregon Board of Pharmacy
COVID-19 UPDATE - March 14, 2023
Updates from the Oregon Health Authority (OHA)
- Oregon will lift mask requirement for health care settings on April 3, 2023.
Workers, patients and visitors in health care settings will no longer be required to wear masks starting April 3, 2023.
OHA is rescinding provisions in Oregon Administrative Rule (OAR) 333-019-1011 that require workers in health care settings – including pharmacies – to wear masks. The requirement has been in effect since August 2021.
In addition, Executive Order 22-24 expired on March 6, 2023. The emergency gave hospitals needed flexibility to respond to a surge in respiratory infections, including COVID-19, RSV and influenza.
OHA's decision to end statewide health care mask requirements aligns with decisions in other states, including Washington.
End of the Federal COVID-19 National Emergency and COVID-19 PHE on May 11, 2023
On Jan. 30, 2023, the Biden Administration announced its intent to end the national emergency and public health emergency declarations on May 11, 2023, related to the COVID-19 pandemic. These emergency declarations have been in place since early 2020, and gave the federal government flexibility to waive or modify certain requirements in a range of areas, including in the Medicare, Medicaid, and CHIP programs, and in private health insurance, as well as to allow for the authorization of medical countermeasures and to provide liability immunity to providers who administer services, among other things.
- FDA’s EUAs for COVID-19 products (including tests, vaccines, and treatments)
A separate emergency declaration pursuant to Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act was issued by the Secretary of HHS in February 2020. Based on this determination, on March 27, 2020, the Secretary declared that circumstances existed to justify emergency use authorization (EUA) of medical countermeasures for COVID-19. An EUA is a mechanism to facilitate availability and use of medical countermeasures that are determined to be safe and effective but have not yet been formally approved. An emergency declaration issued pursuant to Section 564 of the FD&C Act remains in effect until terminated by the HHS Secretary. The timing to conclude the EUA is to be determined; it will not conclude on May 11, 2023, with the other declarations.
- PREP Act Liability Immunity
A declaration under the Public Readiness and Emergency Preparedness (PREP) Act (pursuant to Section 319F-3 of the Public Health Service Act) was issued by the Secretary of HHS in March 2020. This declaration provides liability immunity for activities related to COVID-19 medical countermeasures. Since then, 10 amendments to the declaration have been issued to extend liability protections related to COVID-19 countermeasures. For a PREP Act emergency determination, the Secretary must specify an end date; in this case, it has been set as October 1, 2024, in most cases (although there are some exceptions).
- FDA Notice Concerning COVID-19-related Guidance Documents
On March 10, 2023, FDA issued a notice in the Federal Register addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents the FDA is revising to temporarily continue in effect. Below is a summary list of guidance’s that apply to pharmacies. Please note this list is abbreviated and registrants/licensees should refer to the Federal Register notice for a complete list.
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Table 1—22 Guidance Documents That Will No Longer Be in Effect Upon Expiration of the COVID-19 PHE Declaration
- Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency.
- Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry.
- Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency.
- Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.
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Table 2— 22 Guidance Documents the FDA Is Revising To Continue in Effect for 180 Days After the COVID-19 PHE Declaration Expires. The FDA indicates that these guidances can be discontinued in connection with expiration of the COVID-19 PHE declaration but an additional wind-down period is appropriate to allow for an orderly transition.
- Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals.
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Table 3—24 Guidance Documents FDA Is Revising To Continue in Effect for 180 Days After the PHE Declaration Expires, During Which Time FDA Plans to Further Revise the Guidances
- Emergency Use Authorization for Vaccines to Prevent COVID-19.
- Development and Licensure of Vaccines to Prevent COVID-19.
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.
- Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
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Table 4—4 Other COVID-19-Related Guidance Documents will remain in effect after expiration of the COVID-19 PHE declaration.
- Product-Specific Guidances for Chloroquine and Hydroxychloroquine.
- Policy for Coronavirus Disease-2019 Tests (Revised).
- OAR 855-007 Public Health Emergency Rules
Most rules in OAR 855-007 will no longer be in effect when the Federal COVID-19 PHE ends on May 11, 2023 per OAR 855-007-0010(1).
Joe Schnabel, Pharm.D, R.Ph.
Executive Director, Oregon Board of Pharmacy
3/14/2023
The Oregon Board of Pharmacy serves to promote and protect public health,
safety and welfare by ensuring high standards in the practice of pharmacy and through effective regulation of the manufacture and distribution of drugs.
oregon.gov/pharmacy
The Oregon Board of Pharmacy is an equal opportunity, affirmative action employer committed to a diverse work force.
We respect, reflect and respond to the diverse people we serve.
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