11th Amendment to PREP Act
Extends authorization for qualified individuals,
including pharmacists and pharmacy technicians,
to administer COVID-19 and flu vaccines
Effective May 11, 2023
The 11th amendment to the PREP Act clarifies that COVID-19 continues to pose a credible risk of a future public health emergency, adds two new limitations on distribution, extends the time period of coverage for certain Covered Countermeasures and Covered Persons, clarifies the time period of coverage for Covered Persons authorized under the PREP Act, and extends the duration of the PREP Act to December 31, 2024.
Read the full amendment here.
Authority to Administer COVID-19 Vaccines to Pediatric Patients
The U.S. Food and Drug Administration has authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.
This chart outlines the authorizations in the PREP Act amendments as compared with the Texas Pharmacy Act and TSBP rules.
Chart updated: May 11, 2023
Patients 3 years of age and older
The federal PREP Act amendments supersede state law and authorize pharmacists to order and administer COVID-19 vaccines to patients 3 years of age and older. The PREP Act amendments authorize pharmacy technicians to administer the COVID-19 vaccine to patients 3 years of age and older.
Patients 6 months to under 3 years of age
The federal PREP Act amendments are inapplicable to patients under 3 years of age. The Texas Pharmacy Act and TSBP rules regulate the administration of COVID-19 vaccines to patients 6 months to under 3 years of age.
For patients 6 months to under 3 years of age, a pharmacist may administer the COVID-19 vaccine pursuant to a delegated medical act under Tex. Occ. Code §563.051(b), Tex. Occ. Code §157.002(c), or a written protocol with the patient’s physician with whom a physician-patient relationship has been established (e.g., the infant’s pediatrician) under 22 Tex. Admin. Code §295.15. Under §295.15, a pharmacist may administer the COVID-19 vaccine to a patient under 3 years of age only upon a referral (e.g., prescription drug order with noted directive to administer) from a physician with an established physician-patient relationship.
Please be aware that under Tex. Occ. Code §554.004(c), a pharmacist performing a delegated medical act is considered to be performing a medical act under the supervision of the delegating physician and not to be considered as engaging in the practice of pharmacy. Accordingly, physicians should be made aware of the supervision requirements when delegating to a pharmacist the administration of a vaccine or immunization for patients 6 months to under 3 years of age.
Currently, the Texas Pharmacy Act and TSBP rules do not authorize pharmacy technicians to administer the COVID-19 vaccine to patients under 3 years of age.
Training requirements for vaccine administration
A pharmacist who enters into a written protocol to administer the COVID-19 vaccine must comply with the training requirements specified in 22 Tex. Admin. Code §295.15(c), including the “hands-on training” required under (c)(1)(B)(ii). While subsection (c) does not limit a pharmacist to using routes of administration practiced during the hands-on training, a pharmacist must use professional judgement to determine whether they possess the skills and competence necessary to safely administer a vaccination.
PREP Act Amendments & Texas Pharmacy Act
This chart outlines the authorizations in the PREP Act amendments as compared with the Texas Pharmacy Act/TSBP rules. Click here to view the chart in a new tab. You can also click here to download the chart automatically.
9th Amendment to PREP Act
Expands authority to dispense and administer COVID-19 therapeutics
Effective September 14, 2021
The latest amendment to the PREP Act (ninth amendment, effective September 14, 2021) expands the scope of authority for licensed pharmacists to order and administer and qualified pharmacy technicians and pharmacy interns to administer COVID-19 therapeutics subcutaneously, intramuscularly, or orally as authorized, approved, or licensed by the U.S. Food and Drug Administration (FDA).
The amendment authorizes “[a] State-licensed pharmacist who orders and administers, and pharmacy interns and qualified pharmacy technicians who administer (if the pharmacy intern or technician acts under the supervision of such pharmacist and the pharmacy intern or technician is licensed or registered by his or her State board of pharmacy) FDA authorized, approved, or licensed COVID-19 therapeutics. Such State-licensed pharmacists and the State-licensed or registered interns or technicians under their supervision are qualified persons” if certain requirements are met as outlined by the amendment (Federal Register).
Read the full amendment here.
8th Amendment to PREP Act
Allows Qualified Pharmacy Technicians to
Administer Seasonal Influenza Vaccines
Effective August 4, 2021
The latest amendment to the PREP Act (eighth amendment, effective August 4, 2021) clarifies that “qualified pharmacy technicians are Qualified Persons covered by the Declaration, and [expands] the scope of authority for qualified pharmacy technicians to administer seasonal influenza vaccines to adults within the state where they are authorized to practice and for interns to administer seasonal influenza vaccines to adults consistent with other terms and conditions of the Declaration” (Federal Register).
Read the full amendment here.
Additional amendments to PREP Act
add additional categories of qualified immunizers
Who can administer vaccines? The latest amendment to the PREP Act expands qualified persons that may administer COVID-19 vaccines. Read the full amendment here. - Effective March 11, 2021
A summary chart provided by PHE.gov (Public Health Emergency, U. S. Department of Health & Human Services) outlines these updates for all healthcare providers. The full fact sheet including the chart can be found at PHE.gov here.
Click the chart below to view full-size in a new tab.
You can also click here to download this chart automatically.
Guidance on Vaccinating Phase 1A and 1B Populations
Texas DSHS has issued guidance regarding vaccinating Phase 1A and 1B populations.
Read the guidance here.
Registration for COVID-19 Vaccinations
Pharmacies must enroll in the Texas Department of State Health Services (DSHS) Immunization Program to be eligible to administer COVID-19 vaccines in Texas once they are available. The enrollment portal is now open. A vaccine for the coronavirus, in limited quantities initially, is expected as early as November. DSHS, our state’s public health department, will be responsible for distribution.
Register here:
https://enrolltexasiz.dshs.texas.gov/
Learn more about becoming a COVID-19 vaccine provider here:
https://www.dshs.texas.gov/coronavirus/immunize/provider-information.aspx
The CDC has a number of requirements, including that providers must administer vaccine regardless of a recipient’s ability to pay, provide a vaccination record to each recipient, store doses of vaccine under the proper conditions, and report the number of doses received, used and lost for any reason. All COVID-19 vaccine providers must log their vaccination activities in an online portal.
In addition, be sure your pharmacy is registered with ImmTrac2, Texas’ Immunization Information System (IIS), and register your pharmacy on VaccineFinder.org if you offer immunizations.
Guidance for PREP Act Coverage for Qualified Pharmacy Technicians
and State-Authorized Pharmacy Interns for
Childhood Vaccines*, COVID-19 Vaccines, and COVID-19 Testing
The U.S. Department of Health & Human Services has issued guidance under the PREP Act allowing pharmacy technicians to administer COVID-19 vaccines under certain conditions.
Read the complete guidance statement here: www.hhs.gov/sites/default/files/prep-act-guidance.pdf
*NOTE: Authorization for childhood immunizations as outlined by this amendment ended Thursday, May 11, 2023, in accordance with the expiration of the COVID-19 Public Health Emergency declaration. You can find the details of the previous authorization on this page.
COVID-19 Testing Guidance - June 10, 2020
TSBP has issued guidance statements regarding prescriptions issued for hydroxychloroquine and dispensing drugs in compliance with Emergency Board Rule 291.30*. Read the statements here. - May 15, 2020
*NOTE: Emergency Board Rule 291.30 expires July 17, 2020.
Destruction of Drugs at LTC Facilities - March 24, 2020
Sterile Compounding Guidance - March 13, 2020