The FDA put out a proposed new rule to withdraw 21 CFR § 203.50(a) to deal with court orders striking it down. The courts’ problem with the rule was a regulation that requires that certain information be included in a pedigree, which documents the custody of certain prescription drugs in the drug supply chain.
The FDA has defended its rule while noting the courts’ objections to it. This new rule hopes to reconcile the courts’ concerns.
The rule was struck down in 2006. The FDA gets around to solving it five years later. Maybe “FDA approved” should not be a “get out of jail free” card for drug companies.