RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
Regulatory Focus™ > News Articles > 2020 > 9 > HHS seeks drug importation waiver applicants

HHS seeks drug importation waiver applicants

Posted 30 September 2020 | By Kari Oakes 

HHS seeks drug importation waiver applicants

The US Department of Health and Human Services (HHS) has issued a request for proposals (RFP) from individuals who wish to seek waivers permitting them to import prescription drugs from certain countries.
 
The RFP, issued 24 September 2020, provides a pathway for individuals who have waivers to import some FDA-approved drugs through authorized state-licensed pharmacies. Countries considered an “acceptable foreign source” by HHS for the purposes of the waiver include Australia, Canada, the European Union or a country in the European Economic Area, Israel, Japan, New Zealand, Switzerland, South Africa, or the United Kingdom.

The importation waiver program is meant to be a way to reduce the price of prescription drugs for American consumers; it follows a 24 July executive order on prescription drug pricing by President Donald Trump.
 
Drugs purchased through the waiver program would be sold to individual patients at the authorized pharmacies, each identified in authorized Individual Waiver Importation Plans (IWIPs), said HHS in the RFP. “This pathway would not authorize individuals in the United States to purchase prescription drugs through the Internet, directly from a foreign pharmacy, or from any other foreign seller,” clarified the agency.
 
Waivers will be issued under provisions of Section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C) that permit waivers from the prohibition on drug importation to be granted “under such conditions as the Secretary determines to be appropriate.”
 
To receive a waiver for an IWIP drug, the plan sponsor needs to submit an application to HHS identifying which drugs are to be imported, along with an outline of the program of controls planned for the importation process.
 
Items to be addressed in the control program plan include supply chain security and safety, assurance that each IWIP drug is FDA-approved, and labeling that is FDA-approved and indicates the drug’s status as imported under IWIP.  Also, the program must include measures to make sure the IWIP drug will not become commingled with non-imported drugs in the supply chain, and the specific US pharmacies destined to dispense the IWIP drugs also need to be identified.
 
Controlled substances, biological products, infused and intravenously or intrathecally injected drugs, and parenteral drugs are excluded, as are drugs inhaled during surgery.
 
Applicants may contact import@HHS.gov immediately to begin the waiver process.
 
HHS RFP
 
 
 

Tags: FDA, HHS, US

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe