New FDA Plans possibly impact Supply Chain and related Import Activities

The FDA plans to further enhance the control of the pharmaceutical Supply Chain and associated import activities. The Agency has recently revised its discussion draft to the Food and Drug Administration Globalization Act of 2008 (Title II – Drug Safety) which introduces additional requirements and planned actions to safeguard the pharmaceutical supply chain.
To import a drug into the United States, sufficient information should be provided to demonstrate compliance with “applicable requirements pertaining to identity, strength, quality, purity, approval, listing, labelling and registration”. This compliance may be also demonstrated through verification of a third party.

An even bigger impact may be caused by the demand for a Quality Risk Management Plan in section 505–2, which shall address risk assessment, risk control, risk communication, and risk review of the supply chain. Elements are for example:

  • An assessment based on audits, qualification activities and various evaluations, before the contract with a supplier is made
  • Continuous monitoring of suppliers to ensure the necessary compliance
  • Monitoring of incoming materials
  • Implementation of an effective system to detect risks for the supply chain

Furthermore an electronic statement shall be provided “identifying each prior sale, purchase, or trade of the drug, including each prior sale, purchase, or trade of its ingredients and raw materials.”

It is planned to amend Section 501 of the Federal Food, Drug and Cosmetic Act (21 USC 351) as follows:

Sec. 351. Adulterated drugs and devices:
“A drug or device shall be deemed to be adulterated […]
(j) (1) “the failure to have in effect and implement a quality risk management plan in accordance with section 505–2;
 (2) the failure to provide an electronic statement requested by the Secretary under section 505–2(f).”

Meaning that both Quality Risk Management Plan and electronic statement will be pre-requisites to market a drug in the U.S.

These requirements shall take effect 2 years after the date of the enactment of the applicable Act.

The original discussion draft can be found here.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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