FEDERAL DRUG SAFETY New legislation gives the Food and Drug Administration regulatory authority over compounding pharmacies.

Given the deadly meningitis outbreak of a couple years ago that was traced to a compounding pharmacy that was anything but sterile, it might sound funny to hear me say that custom compounding labs are critical to safe surgical care. But it's true. Compounders supply surgical facilities of all sizes with key medications that are discontinued, back-ordered, recalled or not manufactured in the strength or form that you require.

In the mix
Take epinephrine 1:1000, for example, which is no longer manufactured as both a preservative-free and sulfite-free formulation. You can only get it as such through your compounder. Then there are drug shortages to consider. Must-have crash cart meds like atropine and glycopyrrolate are in short supply today, but your compounder can prepare them for you so you have them on hand when you need them. Compounding labs can repackage your large-volume, single-dose vials of propofol into smaller, unit-of-use syringes, saving you money and stretching the supply of the sedative-hypnotic that always seems to be in short supply. And what about your patients who can't swallow? A compounder can formulate an oral drug into a cream.

This list of benefits of partnering with a compounding lab goes on and on, but as the compounding pharmacy industry moves on from the worst pharmaceutical disaster in decades, it's fair to ask some tough questions. How do you evaluate compounding pharmacies in order to have the best chance of avoiding mishaps like 2012's deadly meningitis outbreak, which was linked to contaminated doses of epidural steroid injections from a Massachusetts compounding pharmacy? How do you know that the sterile compounding pharmacy you're considering is worthy of your trust and your business?

More oversight and scrutiny
It all starts and stops with the now-shuttered New England Compounding Center (NECC). In 2012, NECC shipped contaminated steroid shots to facilities in 23 states. The shots caused the outbreak that killed 64 people and sickened 741 others with fungal infections, making it the country's worst drug disaster in recent memory. It was later discovered that NECC was essentially manufacturing drugs in unsterile conditions, not compounding.

Lawmakers blamed the meningitis outbreak on a lack of regulatory oversight at the state level. To that point, compounding pharmacies had been inconsistently regulated. They fell under the uneven authority of the states' boards of pharmacy, not the FDA. Unlike drug manufacturers, the pharmacies didn't have to register with the FDA or even disclose which medications they produced.

Thankfully, that's changed. Last November, in response to the NECC tragedy, President Obama signed the Drug Quality and Security Act (DQSA), which clarified and in some instances increased FDA's control of drug compounding. The DQSA places sterile compounding pharmacies that ship sterile products across state lines without a patient-specific prescription under the jurisdiction of the FDA. The FDA can demand that those pharmacies release detailed information about their operations and give it greater authority to require safety problems be fixed.

The DQSA even goes a step further with an added level of scrutiny. Compounding pharmacies can voluntarily register with the FDA and be considered a "503b outsourcing facility." Compounding facilities that are voluntarily registered must inform the FDA about drugs they develop, investigate and report adverse events, and include a label that indicates the drugs were compounded. They must also comply with good manufacturing practice requirements enforced by the FDA.

The FDA sent thousands of letters to hospitals calling on them to encourage compounding pharmacies to register with the agency. Of the 700 to 1,000 compounding pharmacies, about 50 are registered outsourcing facilities (view the list at tinyurl.com/mddyfsm).

Develop a relationship
Beyond sterility concerns, here are some strategies you can take to ensure a good working relationship with your compounder:

Work with people you know and trust. Think of partnering with a compounding pharmacy as collaborating with another healthcare professional. Look for a compounder in your ZIP code or close to it. When the next bupivacaine recall hits, you can turn to the compounder you know on a first-name basis and keep your syringes and IV bags full of the agents you need. Remember, you're not ordering from a drug company. You're dealing with a compounded medication that has to be created from scratch. It's wise to have some sort of relationship with the person. You want to be as comfortable with that professional in that compounding pharmacy as you are with sending somebody to another physician or facility.

Of course, you want to vet the pharmacy. Verify that the license is in good standing. This is easy to do. Go to your state board of pharmacy's website and check for any disciplinary actions taken against the pharmacy. Also check the FDA website. The FDA inspects compounding pharmacies when there've been reports of problems. You'll also want to know if your pharmacy is accredited. Don't buy on price. Buy on reputation, and your comfort with the pharmacist's skill set. Finally, go visit your compounding pharmacist partner and see the facility for yourself. You'll be surprised at what you see. Compounding labs are more sterile than your operating room.