COVID-19 is impacting the healthcare system in a way we’ve never seen before, and pharmaceutical manufacturers are facing new challenges at rapid speeds. To help keep you informed, we’re releasing a special Q&A series with our experts to discuss the virus’s impact on each stage of the launch journey.
Today, we spoke with Vice President of PharmaLicense Ryan Fields about the effect of COVID-19 on state licensing.
Vice President of PharmaLicense
How is COVID-19 impacting state licensing?
Due to the current COVID-19 situation, many state governments have mandated restrictions and/or a complete shutdown of ‘non-essential’ businesses and services. The exact impact will depend on the state that a manufacturer is operating in, as well as what sort of license they are pursuing: initial or renewal. Fortunately, Two Labs is able to continue our state licensing services so that your launch timeline can continue as smoothly as possible.
How is COVID-19 impacting initial licensing and business structure change filing?
So far, we have seen a very limited number of states formally defer or waive requirements (e.g., office inspections and fingerprinting), but many states have confirmed that waivers or deferrals are not even a consideration at this time. These are the updates we gathered as of March 26, 2020.
- Arizona: The board has a limited agenda for March 25, 2020 and will not be reviewing applications for approval.
- California: Signature waivers are available and will be reviewed on a case-by-case basis.
- Illinois: Inspections of new in-state facilities have been postponed until April 7, 2020 or when the emergency order is lifted.
- Kansas: Waivers may be requested for inspection requirements in conjunction with new applications made on or before June 30, 2020.
- Louisiana: Any deadlines that are currently in place have been extended by 30 days.
- Maine: Has canceled board meetings through April 30, 2020. Any application that requires review will be tabled until meetings resume.
- Massachusetts: The office has been temporarily closed; therefore, approval of initial licenses may be delayed.
- Mississippi: Offices are closed effective March 17, 2020 until further notice; approval of initial licenses and renewals may be delayed.
- Ohio: There is a 120-day deferral on criminal background checks for applications received after March 2, 2020.
- Rhode Island: A 90-day temporary license is available to manufacturers in good standing in their home state.
- South Carolina: A 90-day temporary permit is available to non-resident facilities in good standing in their home state.
- Washington: Inspections are postponed until further notice.
How is COVID-19 impacting renewal license filing?
Two Labs has been proactively contacting all regulatory agencies to confirm the status of their license application processing. Due to newly implemented work-from-home policies or temporary shutdowns of all operations, many agencies have extended deadlines and/or revised their typical procedures.
- Florida: The renewal deadline has been extended for a period of 30 days for any license or permit with an expiration occurring in March or April.
- Massachusetts: The expiration date on renewals originally expiring after March 10, 2020 will be deferred for 90 days after the state ends their shelter-in-place order.
- Minnesota: For expirations through May 31, 2020, expiration dates remain the same; applications are due by May 1, 2020. Preprinted forms are not being sent to offices to utilize in renewals.
- New Jersey: Controlled Substance Licenses have been extended until May 31, 2020.
- Oklahoma: A waiver has been put in place for clients who are not able to obtain notary for anniversary renewals.
What is your advice for manufacturers who are navigating state licensing at this time?
It is vitally important that manufactures work with a partner who has the capabilities to proactively monitor state-by-state policy and procedure updates. Whether you’re looking for a new business license, renewing a nearly expired one or filing for a change of business license, Two Labs can make sure that your company can stay on track.
What if a manufacturer is operating in a state not listed above?
The above lists represent those states that have provided formal guidance or responded to inquiries as of March 26, 2020. For states that are shut down or not providing responses, we are preparing and filing applications based on normal deadlines and requirements.
For more information on your state, contact Two Labs:
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