CONVENIENCE OF COMPOUNDING Ready-to-use compounded combination dilating drops eliminate the need to administer multiple eye drops before cataract surgery.

Her heart sank when news first broke of the fungal meningitis outbreak traced to tainted steroids prepared by a compounding pharmacy. "What if our vials were contaminated?" Melissa Hermanson, RN, CASC, the clinical administrator of the Ambulatory Care Center in Vineland, N.J., remembers thinking.

"It was tense. You think back over all of the patients — all of their faces — and pray that everything is going to be okay," she says of the 50 or so patients who receive routine pain management injections each week. "Patient welfare is always a No. 1 concern, especially when we're injecting these drugs into spinal columns."

Staff researched the lot numbers of each vial of steroids they'd received from their local vendor to make sure they hadn't come from the New England Compounding Center (NECC), the Massachusetts pharmacy at the center of the 2012 deadly fungal meningitis outbreak, the deadliest medication contamination case in U.S. history. Fortunately for them and their patients, they hadn't.

State and federal regulators say NECC mixed and sold contaminated vials of steroids that sickened 778 unsuspecting patients, killing 76 of them. In the wake of the NECC tragedy, government oversight of compounding facilities has increased, but you still have to do your homework when choosing a compounder. How can you be sure your lab takes medication safety as seriously as you do? You can start by asking these 7 questions.

Is it licensed? Each state in the country is home to a state board of pharmacy, an association of pharmacists who develop, implement and enforce public safety standards for pharmacists. Every U.S. compounding facility should be licensed by the relevant state board of pharmacy. In some cases, when a lab ships compounded medication over state lines, licensing is required by more than one board of pharmacy. This information — who's current and who's not — is often available on a State Board of Pharmacy website. Otherwise, you may need to dig a little deeper; experts recommend calling a state board to ask about any licensure revocations or suspensions.

INCREASED SCRUTINY The 2012 nationwide outbreak of fungal meningitis tied to custom-made steroid injections put compounding pharmacies in the spotlight.

503A or 503B? While the Food and Drug Administration's oversight of compounders has historically been a murky area, regulation has increased since the 2013 passage of the Drug Quality and Security Act (DQSA), following the NECC scandal. Under this law, compounders are classed according to 2 categories: traditional pharmacies that dispense patient-specific compounds only with a prescription (503A); and bulk production outsourcing pharmacies that distribute a high volume of compounded drugs, without prescription, based on anticipatory requests from physicians (503B). Under DQSA, 503B compounders have the option of signing up for direct surveillance from the FDA via routine inspections. A current list of registered operations is available at fda.gov.

NECC often sent facilities compounded medications in bulk, not in response to patient-specific prescriptions. A growing number of states restrict compounding only to patient-specific prescriptions.

The U.S. Pharmacopeial Convention (USP) sets standards for the identity, strength, quality and purity of medicines compounded at traditional 503A facilities. Some state boards of pharmacy, largely responsible for enforcement, have adopted USP standards fully; others, not so much, which is why it's important to ask 503A compounders how they plan to comply with the relevant chapter. You can also check out the yearly surveys conducted by Pharmacy Purchasing and Products magazine (pppmag.com), in which compounders report how well — or poorly — they've followed USP standards.

"There's a lot of folks who have a lot of work to do," says Joseph Coyne, RPh, president of Coyne Consulting in Mundelein, Ill. "But compliance with these standards is a good benchmark. It should be price of entry for a 503A."

Ms. Hermanson suggests a compounder that makes it easy. "Whenever there's a new mandate, my pharmacy reaches out to let me know what it is, and what steps they're taking to comply," she says.

How does the 483 look? If, during a federal inspection, a problem is cited with the design, monitoring or control of a facility's manufacturing processes — as determined by the FDA's Good Current Manufacturing Practices guide — the compounder will be issued Form 483, which details the problem, and this information will be listed on fda.gov. Violations are common; at press time, 50 registered facilities had been issued a 483.

"Merely receiving a deficiency form isn't enough reason to disqualify a facility," says Mr. Coyne. "Some violations are egregious, like what we saw in New England, but others are less so, and may only require a reinforcement of education among staff. The important thing is to engage in a conversation. Ask the facility to explain what happened, and what the remedy is to correct the situation. Then you can make an educated decision."

You can also sign up for the FDA's free MedWatch report (fda.gov/safety/medwatch), which provides updates on enforcement actions specific to registered compounders.

Is it accredited? Non-profit credentialing groups offer voluntary accreditation programs for compounders. One of the leading groups in this area is the Accreditation Commission for Health Care, which offers a credentialing option through the Pharmacy Compounding Accreditation Board. The program, established by 8 of the nation's leading pharmacy organizations and typically geared for 503A facilities, is based strictly on standards set forth by USP.

Another avenue is available through the National Association of Boards of Pharmacy, which offers the Verified Pharmacy Program. This program is specifically designed for 503B pharmacies seeking licensure in multiple places, as it helps them keep abreast of regulatory changes in each state. For a breakdown of new credentialing and inspection authorities, keep an eye on the International Academy of Compounding Pharmacies website (iacprx.org), which will be unveiling a matrix of available options in the coming months.

"Think of these accreditations as the Good Housekeeping seal of approval," says David Moran, PharmD, BCPS, division director of clinical pharmacy for HCA Healthcare's MidAmerica Ambulatory Surgery Division. "Yes, governmental regulatory boards exist, but when they get busy in a tight world, they might put off a facility's inspection, whereas these credentialing groups operate under a finite timeline."

What does your GPO say? Because it's likely your medical facility works with a designated Group Purchasing Organization, or GPO, a good strategy while shopping around for a compounder is to seek advice from this entity. Oftentimes, GPOs will have a list of approved compounders that have gone through their own auditing and vetting process. They will be able to steer you toward a reputable facility and — bonus — they may be able to get you a better price.

Do they communicate? As with any healthy relationship, communication with your compounder is key. Quality directors should avail themselves for answering any questions you have — and you should have questions. Completing due diligence in this process means being a squeaky wheel. Ask to see test results, pedigree documentation (records of drug formula preparation), internal standard operating procedures, continuing education policies or references from other providers who use their services. You may want to enlist the help of your facility's consulting pharmacist in formulating these questions. Once you've selected a compounder, schedule a conversation at least quarterly to find out how many batches have been rejected internally in recent months, and why. And consider assigning a point person in charge of developing — and monitoring — this relationship.

For Kathy Spencer, BSN, RN, clinical director for Horizon Eye Care in Margate City, N.J., this communication isn't just about due diligence, it makes life more convenient. "I talk with my lab's lead pharmacist once or twice a week via email," she says. "Because we have a relationship, if I ever need something last minute, it's easier to get."

Do they allow on-site visits? "Any good-caliber facility should be more than happy to provide a private inspection," says John Voliva, RPh, executive VP of the International Academy of Compounding Pharmacists in Missouri City, Texas. "Nothing beats an eyes-on, hands-on view of the pharmacy you've chosen to use. In the end, this is the thing that will give you the greatest peace of mind." Ms. Hermanson agrees. "I'd say we're all more vigilant now," she says. "I've taken care to make sure our compounding lab cares as much about our patients as we do, and I've been very happy with the results." OSM