Industry Urges FDA to Impose Stricter Standards on Exemptions for Near Replicas

Industry is asking the FDA to impose stricter requirements for outsourcing facilities to qualify for an exemption that allows them to produce near replicas of approved products.

Outsourcing facilities can compound a drug product as long as at least one of the following characteristics is different from the reference product:  the active ingredient, route of administration, dosage form, dosage strength and excipients.

The FDA imposes these requirements to ensure outsourcing facilities do not compound near replicas for patients who can use an approved product, but there are loopholes that allow outsourcing facilities to circumvent these restrictions, industry says.