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# API Rules Send Drug Manufacturing Offshore: Attorneys
- URL: https://www.fdaweb.com/api-rules-send-drug-manufacturing-offshore-attorneys/
- Published: 2018-03-01T12:00:00.000Z
- Updated: 2026-09-14T23:26:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140876

Attorneys **David Gibbons** and **Dara Levy** (Hyman, Phelps and McNamara) say that FDA interpretations of regulations on importation of active pharmaceutical ingredients (API) are driving manufacturing of investigational finished drug products outside the U.S. In a [post](http://www.fdalawblog.net/2018/03/fda-is-driving-the-manufacture-of-drug-products-outside-the-united-states/?ref=fdaweb.com) in their firm’s *FDA Law Blog*, the two write that under the agency’s current interpretation, a batch of investigational API cannot be imported for manufacture of a finished product without an IND, but an IND can’t be obtained without analysis and stability data on the drug product.

“As a result,” they explain, “investigational API and drug product, from a practical perspective, must be made entirely within or entirely outside the U.S. Because API manufacturing is largely done outside the U.S., FDA’s requirements have the effect of encouraging sponsors to manufacture outside the U.S. to the detriment of pharmaceutical developers, U.S. contract manufacturers, and patients.”

In essence, the post concludes, FDA’s current interpretation of its regulations may delay the importation of API at critical times during the development cycle and thus result in an overall delay to drug development. It may also present substantially increased costs involved with manufacturing the same finished drug product twice, but for different uses. Manufacturing drug product outside the U.S. may be a viable strategy for eliminating certain delays imposed by regulatory requirements, the attorneys say. They say an unintended consequence of FDA regulations covering API importation may be to drive drug manufacturing outside the country.

“FDA should interpret and enforce the law and regulations to allow for the intended use of imported API to ‘evolve’ through the drug development cycle,” Gibbons and Levy add.