Christina Moylan, LPN, was caught off guard when she found out the compounding pharmacy she had spent 2 years building a great relationship with would no longer prepare preservative-free triamcinolone acetonide, which her retinal surgeons used to visualize the posterior cortical vitreous during pars plana vitrectomy, because there wasn't enough demand. Ms. Moylan only ordered around 10 $25 vials a month. In search of a new pharmacy, the materials manager at the Island Eye Surgicenter in Westbury, N.Y., decided to take a chance by posting on the ASC Association's community message board:

Does anyone use a compounding pharmacy (503B) to supply triamcinolone 40mg or 60mg per ml — preservative free? My current 503B is no longer providing it.

Ms. Moylan was excited when a facility manager recommended the compounding pharmacy she used. But when Ms. Moylan did some digging, she discovered some skeletons in the potential new partner's closet: The pharmacy produced 3 drugs that had been involved in nationwide recalls for sterility issues.

"Any recall of any sort is a red flag," says Ms. Moylan. "I didn't want to use that compounder."

Her experience leads to the first and most important piece of advice when searching for a new drug compounder: Do your research to make sure the pharmacy has a proven track record of safety and a clean reputation, and ask these key questions before taking the plunge.

1. Is it a 503B?

The spotlight has shone brightly on compounding pharmacies since the 2012 New England Com-pounding Center disaster. The compounding pharmacy in suburban Boston produced and distributed mold-tainted vials of an injectable steroid used to treat back and joint pain. The steroids sparked a widespread meningitis outbreak that killed 64 patients and sickened more than 750 others.

It was an alarming and eye-opening tragedy that completely changed the way facility leaders looked at their drug suppliers and (hopefully) has you confirming the drugs you receive are safe instead of assuming that they are.

There was a silver lining to the NECC mess: Congress responded in 2013 by passing the Drug Quality and Security Act (DQSA), which established 503B outsourcing facilities. The suppliers who work under that label are permitted to compound drugs in bulk and therefore are held to higher safety standards. They're also required by law to register with the FDA, comply with Current Good Manufacturing Practice (CGMP) standards and to meet certain other quality requirements such as reporting adverse events to the FDA and providing the agency with information about the products they compound.

"Because compounds are made under CGMP standards at facilities inspected regularly by the FDA, drugs from 503B facilities are less likely to be contaminated, more likely to be of the appropriate potency and more likely to be chemically stable," says Jane A. Axelrad, principal at Axelrad Solutions and former FDA drug regulatory policy chief who was instrumental in getting DQSA passed.

2. Is it FDA-registered?

Despite passage of the DQSA, not all pharmacies that compound drugs register with the FDA. To ensure you work with a reputable supplier, check the updated list of FDA-registered compounding facilities: osmag.net/KmAA2h. The list also provides contact names and phone numbers of each facility.

Your work isn't done when you reach out to an FDA-registered 503B facility. Knowing the right questions to ask and the correct responses to receive is critical. The American Society of Health-System Pharmacists (ASHP) Research and Education Foundation developed the "Outsourcing Sterile Products Preparation Vendor Assessment Tool," a free online guide you can use when asking compounders about their processes. Download a PDF at outpatientsurgery.net/forms.

The tool features a long list of questions, the answers to which will help you compare the service each vendor provides: Is this potential vendor compliant to current regulations? Does it make drugs that will be safe to use? Does it maintain an environment that is suitable for compounding pharmaceuticals?

"Any recall of any sort
is a red flag."
— Christina Moylan, LPN

The ASHP Foundation's tool is "universally recognized," says Sheldon S. Sones, RPh, FASCP, a pharmacy consultant based in Newington, Conn. He encourages you to work with a consultant when using the tool and analyzing its results.

The FDA also provides a transparent look at what its inspections of compounding pharmacies turned up — maintaining a clean facility, using proper aseptic technique — and if and how the facilities responded to identified deficiencies: osmag.net/qV2KZp.

Some red flags are redder than others, reminds Mr. Sones. "You may be able to deal with a finding that a facility's drug labels are slightly illegible," he says, "yet it would obviously be unacceptable if a facility got cited because it had dirty floors and dust in the sterile area or because it only tested its products once a year."

3. Does it have an open-door policy?

Ms. Moylan eventually found a potential new compounder in Vermont and accepted an open invitation to visit the facility. She thought that transparency and the recent FDA inspection report the pharmacy willingly sent were good signs, but still wanted to see the compounders in action and get feel for the place.

"During my visit, I pointed out that the FDA's report included several recommended improvements," says Ms. Moylan. "I wanted to know what those issues were and how the pharmacy was addressing them. The staff was very forthcoming."

The reported issues were minor — nothing that would negatively impact medication compounding — and Ms. Moylan appreciated the pharmacy's willingness to open its doors and share the FDA's findings. She wouldn't have had that experience or gained that perspective without trekking to Vermont.

"Get out there and ask the questions you want answered," she says.

Request inspection reports and find out how a pharmacy responds to any concerns turned up during inspections, suggests Ms. Moylan. "See if they're receptive to you being there," she adds.

"Onsite visits might be the only way to get a true feel for a compounder."

4. Is it willing to be audited?

It's also a good idea to conduct more in-depth audits of a compounder's services, according to Greg Rockers, RPh, who has operated 2 503B outsourcing facilities and assisted organizations in navigating multiple FDA inspections. He says your audits should mimic what FDA inspectors cover during their on-site visits — everything from the physical condition of the building's exterior and clean room to the policies for developing formularies, establishing beyond-use dates and testing the sterility of finished products.

Conducting your own audits can be a valuable exercise because some FDA-registered 503B facilities have not yet been inspected, according to Mr. Rockers. Audits should give you a sense of how compounding facilities handle customer complaints and investigations. Effective audits typically span 2 to 3 days and should be conducted at least annually, says Mr. Rocker, but it would be ideal to conduct 2 audits each year: the first unannounced and the second about 9 months later.

5. Is it locally licensed?

States vary in their licensure requirements and the approaches they have to inspections and enforcement of compounding facilities, according to Ms. Axelrad. "Some states may be more willing to share information about facilities than others," she says. "You can call the state board of pharmacy in the state where the compounding pharmacy is located and ask them: "Are they licensed by you? What kind of info can you give me about this facility?'"

Never settle

Don't put your blind trust in recommendations from other facility leaders, says Ms. Moylan, who's thankful she did her own due diligence on the suggestion from the ASC Association message board.

"You're ultimately responsible for determining if the compounding pharmacy you work with is safe," she says. "You have to be supremely confident that you're providing the very best medications to your patients. You have to feel comfortable that whichever compounder you choose meets your high standards." OSM