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On Dec. 9, Gov. Inslee modified Proclamation 20-36 to give pharmacies the flexibility they will need to store and access COVID-19 vaccines and treatments in locations outside of their pharmacies. These new statutory and regulatory waivers will continue until January 8, 2021, at which point the Legislative leaders will need to approve an extension, which has been common through the COVID-19 response. This information is also in the Pharmacy Quality Assurance Commission’s Plan-19.
Proclamation waivers to allow off-site storage by pharmacies
The new waivers permit pharmacies to store outside of the pharmacy’s main licensed location COVID-19 vaccines and drugs for treating COVID-19 for which the U.S. Food and Drug Administration has issued an emergency use authorization, license, or other approval.
Pharmacists may authorize non-pharmacy staff members to access the areas where these vaccines and drugs are stored without having to immediately supervise the non-pharmacy employees while they are doing so.
For instance, a hospital pharmacy may store COVID-19 vaccines in a hospital lab’s ultra-cold freezer. Lab staff members may continue accessing the freezer and the area where the freezer is located without having to be immediately supervised by a pharmacist. Another example is that a retail pharmacy may partner with a private, independent lab or other enterprise to store vaccines in their freezers, and the staff of that lab or other enterprise will not have to be supervised by a pharmacist.
Pharmacies may store COVID-19 vaccines and drugs in locations outside of the pharmacy; however, current pharmacy standards still apply to store the vaccines and drugs in a facility with adequate security to protect them from unauthorized access, acquisition, or use.
Redistributing vaccines
Redistribution of COVID-19 vaccines to facilitate quick and effective vaccination, and to alleviate temporary shortages to aid in ending the COVID-19 pandemic, will be permitted. This qualifies as being done for emergency medical reasons. Redistribution of COVID-19 vaccines and treatments among pharmacies, health care facilities, and health care practitioners will not constitute wholesaling under the current law.
Commingled storage of vaccines and laboratory materials and specimens
Because ultra-cold freezer space is scarce, COVID-19 vaccines may need to be stored in the same freezer unit as laboratory materials and specimens. Unless the FDA’s emergency use authorization for a COVID-19 vaccine prohibits it, the Pharmacy Quality Assurance Commission and the Department of Health – as the regulating agencies for pharmacies, medical test sites (laboratories), and hospitals – will permit commingled storage of COVID-19 vaccines and laboratory materials and specimens. The state will apply the standard in the CDC “Pink Book,” which requires potentially contaminated laboratory items (e.g., blood, urine, and stool) to be properly contained and stored below vaccines to avoid contamination from drips or leaks.
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