Coronavirus Disease (COVID-19) Resources
TSBP Resources & Guidance
TSBP resources and guidance are compiled as they become available and are listed below.
- 1. The hospital pharmacy receives the drugs from the wholesaler and distributes them to the medical staff at the infusion location under the supervision of the practitioner. The distribution of the drugs to the practitioner prior to compounding is allowed so long as a record is made by the pharmacy. Any compounding done at the bedside for infusion by the practitioners’ medical staff does not fall within the purview of TSBP and would not be prohibited.
- 2. The hospital pharmacy compounds the drugs at the pharmacy for infusion for a specific patient and then delivers the compounded preparation to the infusion location. This process would be allowed under pharmacy laws for dispensing a drug and delivering it to the practitioners’ practice site for administration.
- 3. The hospital pharmacy compounds the drugs at the pharmacy and then delivers the compounded preparation to the infusion center without a specific patient identified as the recipient. This process would be allowed under pharmacy laws specific to compounding for office use of the practitioner.
- The vaccine must have FDA approval or licensure;
- The vaccine must be ordered and administered according to ACIP immunization schedules;
- The licensed pharmacist must complete at least 20 hours of ACPE-approved practical training that includes hands-on injection technique, clinical evaluation of indications and contraindications, and recognition and treatment of adverse, emergency reactions to vaccines;
- The licensed or registered pharmacy intern must also complete an ACPE-approved practical training program;
- The administering pharmacist/intern must have a current certificate in basic cardiopulmonary resuscitation;
- The administering pharmacist/intern must complete a minimum of 2 hours of ACPE-approved, immunization related continuing pharmacy education during each state licensing period;
- The licensed pharmacist must comply with jurisdiction-based recordkeeping and reporting requirements, including informing the patient's primary-care provider, submitting immunization information to state/local IIS, complying with requirements for reporting adverse events, and complying to requirements for the provider to review the registry/records prior to administering a vaccine;
- The licensed pharmacist must inform pediatric patients and accompanying adult caregivers of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients when appropriate.
Monoclonal Antibody Treatment Information
Registration for COVID-19 Monoclonal Antibody Allocation
Qualifying long-term care, SNF, and rehabilitation facilities interested in registering to become providers of monoclonal antibodies in Texas may do so through the DSHS form found here: https://survey.alchemer.com/s3/6060302/COVID-Monoclonal-Antibody-TX
NOTE: This is a separate registration process from COVID-19 vaccine administration registration. Please see the section regarding vaccine registration below.
TSBP Guidance Regarding Monoclonal Antibody Treatments
The Texas State Board of Pharmacy (TSBP) has received numerous inquiries regarding the compounding and/or distribution of monoclonal antibodies, such as bamlanivimab, by hospital pharmacies for infusion for the treatment of patients with COVID-19. The scenarios presented as a solution are varied and have been evaluated for compliance. Each one outlined below appears to be in compliance with pharmacy laws.
You can download a PDF copy of this guidance statement here.
Immunization Procedures
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
Childhood Immunizations
Pharmacists and pharmacist-interns acting under the supervision of a pharmacist are allowed to order and administer immunizations to children 3-18 years of age as authorized by the third amendment to the PREP Act under the following conditions:
The amendment to the PREP Act authorizes state-licensed pharmacists (and pharmacy interns acting under their supervision to administer vaccines, if the pharmacy intern is licensed or registered by his or her state board of pharmacy) to order and administer vaccines to individuals ages three through 18 years, subject to several requirements including training, recordkeeping, and reporting. The vaccine must be approved or licensed by the Food and Drug Administration (FDA) and must be ordered and administered according to the CDC’s Advisory Committee on Immunization Practices (ACIP) immunization schedules. Learn more about CDC recommendations for childhood vaccines.
HHS is expanding access to childhood vaccines to avoid preventable diseases in children, additional strains on the healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with an additional resurgence of COVID-19.
Please refer to the third amendment of the PREP Act for more information and guidance: www.hhs.gov/sites/default/files/third-amendment-declaration.pdf
You can also find more general information about the Vaccines for Children program on Texas DSHS's website here: https://www.dshs.texas.gov/immunize/tvfc/info-for-providers.aspx
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
