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.

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Ryan Fields
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 June 8, 2020.

Click here for an update on your state
  • Alabama: Remote, video, and electronic notarization will be accepted while in State of Emergency.
  • California: Signature waivers are available and will be reviewed on a case by case basis
  • Florida:
    • E-signatures will be accepted, if necessary.
    • State is requesting that applications are submitted online.
  • Ohio Board of Pharmacy : 120-day deferral on criminal background checks for applications received after March 2, 2020 and prior to June 14, 2020.
  • Illinois: Inspections of new in-state facilities have been postponed until State of Emergency is lifted, which has been extended until June 27, 2020.
  • 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
  • Maryland: Conducting “virtual” inspections of in-state facilities in order to prevent delay of initial licensure.
  • Montana: The State has requested that paper apps not be sent at this time. Applications will continue to be accepted online.
  • New Jersey: Initial licensing inspections are postponed until further notice.
  • New York: Electronic notarization is accepted.
  • Oregon: Staff is working remotely and focusing efforts on COVID-19 related items. Processing of new applications will be delayed.
  • Rhode Island: 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
Click here for an update on your state

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.

  • Alaska:
    • All licenses have been extended until September 30, 2020
    • Renewals are not being processed at this time
  • Commonwealth of Massachusetts – Delay in License Approvals:
    • Office has been temporarily closed; therefore, approval of licenses and renewals may be delayed.
    • All licenses that were set to expire prior to March 10, 2020 will be given an extension of 90-days after the State of Emergency is lifted.
  • Oklahoma Board of Pharmacy – Expiration on Anniversary Dates: A waiver has been put in place for clients who are not able to obtain notary until June 6, 2020.
  • South Carolina: Renewals are open, but all expiration dates have been extended until September 30, 2020
  • Washington DC: All licenses have been given a 45-day extension.

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 June 8, 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:

Click here for an update on your state

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