Shortage-drug compounding threat stripped from Senate bill

Good news about the so-called “SAFE" Drugs Act, currently before the U.S. Senate Committee on Health, Education, Labor, and Pensions. The latest changes — known as a “manager’s amendment” — are a big step in the right direction. The amended bill passed out of committee this week and is headed for consideration in the full Senate.

Here’s what changed, and it’s thanks not only to our advocacy team, but to everyone who wrote, called, faxed, or carrier-pigeoned their senators explaining the dangerous issues with the original bill.

• The big one: The amendment removes the bill’s "definitions" section, notably the “essentially a copy” language that contradicted the FDA Guidance for Industry. That means the status quo would remain for compounding drugs on FDA’s shortages list. (Other definitions that would remain intact are those for “regularly or in inordinate amounts” and “commercially available.”)
• The bill would add mandatory serious adverse-event reporting by compounding pharmacies — the emphasis is on serious (that’s good), and that would be through the existing FAERS/MedWatch system.
• Instead of a 20 shortage-drug limit for 503A pharmacies, the bill would require pharmacies shipping more than 5 percent of their compounded drug products out of state to report that information to FDA.
• Compounded drugs would have new mandatory labeling that’s essentially the wording we suggested: “This medication has been compounded for dispensing to an individual patient and has not been approved by FDA.”