A-List Healthcare

In 2012, one pharmacy’s injections killed 64 people. Here’s how to check yours.

The outbreak changed federal law and left a trail of public records any patient can read. This guide shows you where those records are and what they mean.

Updated November 20268-minute readSources: CDC, FDA, U.S. Justice Department

What happened

In September 2012, doctors in Tennessee found a rare fungal meningitis in a patient who had received a steroid injection for back pain. Within weeks, the cases spread across the country.

The steroid came from the New England Compounding Center, a pharmacy in Framingham, Massachusetts. Its vials were contaminated with mold. They had been shipped to clinics in 23 states and injected into patients’ spines.

751people infected
64deaths counted by the CDC
20states with cases

Source: CDC, October 2013. Prosecutors later put the death toll at 76.

Investigators found the pharmacy had been operating like a drug factory while licensed as a pharmacy, shipping large batches without the safeguards a manufacturer must follow. Its owner, Barry Cadden, was later sentenced to 14½ years in federal prison (Justice Department).

What changed

In 2013, Congress passed the Drug Quality and Security Act. It split compounding pharmacies into two kinds, and the difference tells you who is watching the place that makes your medicine.

503A pharmacy

Makes medicine for one patient at a time

  • Needs a prescription written for you
  • Licensed and inspected mainly by state pharmacy boards
  • The FDA inspects some, often after a complaint

503B outsourcing facility

Makes larger batches, often for clinics

  • Registered with the FDA
  • Must follow federal manufacturing rules
  • Inspected by the FDA on a risk-based schedule

Neither kind makes FDA-approved drugs. Compounded medicines don’t go through FDA review for safety or effectiveness before you get them. That’s why checking the pharmacy matters.

Get the free 10-point checklist

The checks below on one printable page, so you can run them before your next fill.

Free PDF. We’ll also email you plain-English updates when compounding rules change. Unsubscribe in one click.

1.Check the license in your state

A pharmacy that ships to you must be licensed in your state, not just its home state. Ask your provider which pharmacy fills your prescription, then look it up on your state board of pharmacy’s license search.

Most boards show whether the license is active and whether the board has taken action against it. Find your state’s board through the National Association of Boards of Pharmacy.

2.Read the FDA record

Three FDA documents come up again and again. Knowing the difference keeps you from panicking over the wrong one.

Form 483
A list of things an FDA inspector noticed at the end of a visit. Almost every compounder that gets inspected receives one. It isn’t a final finding that the law was broken.
Warning letter
The FDA’s formal notice of significant violations. The pharmacy must respond with a fix, usually within 15 working days. Note what it was for and how recent it is.
Close-out letter
The FDA’s confirmation that a warning letter’s problems appear to be fixed. It’s a good sign to see one.

Where to look:

3.Weigh the record against the pharmacy’s size

A pharmacy that fills tens of thousands of prescriptions a week gets inspected far more often than one with ten employees, so it will usually have more paperwork. A long record isn’t automatically worse than a short one.

Look at three things instead: how recent the problems are, whether they were about sterility or ingredients, and whether the FDA later closed them out.

4.Know the red flags

  • The product is sold without a prescription, or labeled “for research use only” or “not for human consumption.”
  • The pharmacy won’t share a certificate of analysis for your specific lot.
  • It isn’t licensed in your state, or you can’t find out where it’s located.
  • The seller calls a compounded medicine “FDA-approved.”
  • Everyone gets the same “personalized” formula at the same dose.

5.Ask your provider four questions

  1. Which pharmacy fills this, and is it a 503A or a 503B?
  2. Is that pharmacy licensed in my state?
  3. Why do I need a compounded version instead of an approved one?
  4. Can I see the certificate of analysis for the lot I’m getting?

Most people can’t confirm all of this on their own.

Some of these checks are hard to verify from outside a pharmacy. Each one matters: in 2012, one pharmacy’s contaminated injections killed 64 people. The records that would warn you are public now. We gather them, review them and put them in plain English, so you don’t have to guess.

Get the free checklist

Or take the guesswork out with A-List for $5 a month.

Sources