FDA and NABP Temporarily Curtailing Onsite Inspections Due to COVID-19
In order to ensure the safety of its employees both FDA and the National Association of Boards of Pharmacy (NABP) have made temporary changes to their inspectional activities as they adjust and adapt to the evolving COVID-19 pandemic and the spread of its variants throughout the United States.
FDA is again halting onsite routine domestic and foreign surveillance inspections for the time being. The Agency will continue to conduct “mission critical” inspections and work in the areas of: Human and Animal Food, Human and Animal Drugs, Medical Devices and Radiological Health, Biologics, Bioresearch Monitoring, and Tobacco with the hope of resuming routine inspections as soon as possible. FDA does plan to continue its use of a risk based approach and “alternative tools” to supplement their lack of eyes in the facilities of drug and medical device manufacturers. FDA has issued guidance on remote inspections, as well as has drafted a Resiliency Roadmap for FDA Inspectional Oversight that can be downloaded for reference.
Factors that FDA will use in determining “mission critical” inspections include;:
- Product received breakthrough therapy or regenerative medicine advanced therapy designation;
- Product is used to treat a serious disease or medical condition and there is no substitute;
- Product requires follow-up due to recall, or there is evidence of serious adverse events or outbreaks of a foodborne illness; and
- Product is related to FDA’s COVID-19 response (e.g. drug shortages).
The wide array of “alternative tools” that FDA might use include:
- Reviewing records and information requested from facilities in advance or in lieu of certain drug and biological product inspections to support regulatory decisions and actions as authorized under section 704(a)(4) of the Federal Food, Drug, and Cosmetic (FD&C) Act;
- Applying remote assessments for individual program areas to evaluate facility records;
- Leveraging information shared by trusted state, local, tribal, and territorial regulatory partners;
- Leveraging information shared by trusted foreign regulatory partners through mutual recognition and confidentiality agreements;
- Sampling and analytical testing of FDA-regulated products both domestically and at international borders; and
- Refusing entry of unsafe imported products into the U.S.
NABP is also monitoring the current COVID-19 situation and is continuing to expand the list of states in which it has temporarily halted onsite surveys and inspections of facilities. On January 14, 2022, NABP’s list of no go states included 36 and the District of Columbia. The list, at least for now, continues to grow. As of January 24, 2022, NABP published that they are conducting surveys or inspections in the following states:
- New York
- West Virginia
NABP has, however, indicated that they may be willing to (at their discretion) conduct an onsite survey or inspection in one of the no go states provided that the facility is located in a specific county or city where the COVID-19 case positivity rate is lower than the state’s reported average.
Although the following are subject to change at any time, NABP’s COVID-19 current requirements include:
- a written attestation prior to the onsite visit that states that the facility is complying their COVID-19 requirements;
- a written description of the methods in place to detect and prevent the spread of COVID-19;
- during the survey or inspection, all facility employees that they may come into contact with will wear face covering and practice social distancing when possible;
- when the facility is notified that an onsite survey or inspection will take place, the facility must provide the number of any potential or known COVID-19 cases that have occurred within the previous 30 days; and
- if after providing that COVID-19 information for the previous 30 days that information changes, they must notify NABP between the time of submission and up to 10 days after the survey or inspection takes place.
NABP continues to monitor the ever changing situation and updates to the states effected can be found on their website on the “Coronavirus Updates” page.