The Future of Compounding Pharmacies


With the growth of individuals turning 65 and over each day, doctors and patients may turn to compounding pharmacies at an increasing rate to prepare medications with alternate doses and strengths. Jerry Greene R.Ph., FACA, Founder & Director of San Diego Compounding Pharmacy, has been a practicing compounding pharmacist in San Diego for two decades. He explains some of the many benefits of using a Compounding Pharmacist. A must listen to!


Your health: The custom-mixed meds alternative

Tuesday, November 3, 2009 at midnight

Jerry Greene, who owns San Diego Compounding Pharmacy in Kearny Mesa, says his lab produces a lot of custom-tailored pain prescriptions

In this age of "have it your way" burgers, made-to-fit jeans and personalized ring tones, it’s no surprise that prescription medicine also can be customized.

From converting hard-to-swallow pills into easy-to-use transdermal creams for seniors, to changing bitter-tasting medicine into cherry-flavored gummi bears for children and fish-flavored liquid for finicky felines, compounding pharmacies create medicines to meet unique needs that can’t be fulfilled by mass-produced drugs.

"Customized medications offer the patient more options. We work between the physician and the patient to tailor doses, flavor and consistency for the specific requirements of a patient," says Sanam Ansari,pharmacy manager at Pharmaca Integrative Pharmacy in La Jolla, which offers compounding in addition to traditional pharmacy services.

Because many people have allergies to the preservatives, dyes or yeast in some commercial medications, compounding pharmacists like Jerry Greene remake the medications without these fillers, just using the active ingredients.

"As a compounding pharmacy, we’re helping people who need specialized medicines," says Greene, who owns San Diego Compounding Pharmacy in Kearny Mesa. "We do a lot of pain management (prescriptions) such topical analgesics for people who don’t want to take a lot of NSAIDs (nonsteroidal anti-inflammatory drugs). We can make seizure-control medications in suppository form and specialized wound-care products."

The practice of compounding is not new. It actually predates the mass production of medicine, which didn’t come about until the 1950s. Compounding took a back seat to quick and easy manufactured medicine but has recently seen a resurgence via modern technology and innovative techniques and research.

All pharmacists and pharmacies in California are authorized to compound medications, but not all do. About a half dozen pharmacies in San Diego County focus on compounding, while dozens of others offer compounding as one of many services.

Compounding now accounts for about 1 percent of all prescriptions in the United States, or about 30 million prescriptions annually, generating about $1 billion a year in sales, according to the International Academy of Compounding Pharmacists (IACP), a professional group of more than 2,000 compound pharmacists, or about half of those in the United States.

As with most things custom made, you’ll probably pay more for a compounded prescription than a mass-produced one.

"(Compounders) have to make it, so of course it’s going to cost more. It’s a whole different process. It’s different from pulling it off the shelf and handing a pre-made product to the patient," says Rod Shafer, CEO of Houston-based IACP. "A compound pharmacist is not only taking the time and effort to make it especially for you, but they’re also doing batch testing for potency and sterility. There’s a lot more involved than people realize."

Getting health insurers to pay for compounded medications "can be a huge struggle," Shafer admits, noting that compounders have recently been notified that Medicare will no longer cover compounded medications.

Although specialized medications are the results of the skills and training of pharmacists, the concept for the unique drugs must originate with the doctor. Compounded medications are ordered via a physician’s prescription listing proper dosage, strength and any recommended changes in delivery, flavor, etc.

"It’s imperative that pharmacists, especially compound pharmacists, be part of the triad between the pharmacist, physician and patient," Ansari says. "We talk to the patient and can give suggestions about things that will work, but before we go ahead, we talk to the doctor. We need the physician’s final approval before we go ahead with (making) the product."

Although compounding pharmacies offer consumers more options, they also require consumers to take more precautions, the Food and Drug Administration says.

While the ingredients in compounded medications are FDA-approved, the final product is not.

"There may be unknown risks when using a compound (medication) since they don’t go through the same approval process as FDA-approved drugs and there is no data available," says Kathleen Anderson, deputy director of the FDA’s Center for Drug Evaluation and Research in Maryland.

Pharmacies, including compounding pharmacies, are regulated by state boards, not the FDA, which regulates drug manufacturing.

The FDA also is concerned with compounders — especially large Internet pharmacies — which produce and stockpile mass quantities of compounded drugs and make claims touting the benefits of their compounded medicines over manufactured drugs.

"There’s a blurry line when compounding crosses from compounding for an individual patient to compounding for the general public, in which case it becomes manufacturing," says Virginia Herold, executive officer for the California State Board of Pharmacy in Sacramento. "And, when it becomes drug manufacturing, it then falls under the FDA."

Critics accuse some compounders of acting like drug manufacturers, doctors or both, but without the appropriate safeguards. However, Herold expresses confidence in most compounding pharmacies and points out that mass-produced drugs have not been without their own serious problems resulting in worldwide product recalls.

"If a compounding pharmacy follows proper procedure, the consumer is no more at risk using a compound medication than a manufactured one," Herold says. "But the consumer must know what to look for when (getting) compounded medicine.

Chemicals were weighed at San Diego Compounding Pharmacy in Kearny Mesa, where, for a premium price, patients get medicine compounds adjusted to preferences and special needs. K.C. Alfred/Union-Tribune photos

Jerry Greene,owner of San Diego Compounding Pharmacy, says his lab produces a lot of custom-tailored pain prescriptions.

Consider the following tips when getting compounded medicine:

•Ask your doctor to recommend a compounding pharmacist. Look for an experienced compounding pharmacist. Ask if the pharmacist regularly compounds the drug you need. If the answer is "no," look for another who does.

•Try to use a local compounding pharmacy, so you can check it out in person. "Take a close look around. Does the pharmacy seem clean and well organized and professional? Or, does it look crazy and chaotic? If so, you may want to go to another pharmacy," says Virginia Herold, executive officer for the California State Board of Pharmacy in Sacramento.

•Ask about the pharmacy’s quality-control procedures. Look for pharmacies that do third-party testing for sterility, potency or contaminants. "We send out all injectables, and we randomly send out creams and capsules to an independent third-party lab," says pharmacist Jerry Greene, owner of San Diego Compounding Pharmacy.

•Make sure the pharmacists are accessible. "It shouldn’t take a pharmacist three days to return your call. When you’re dealing with someone’s health, it’s especially important that a pharmacist be available," Greene says.

• Make sure you’re not given a compounded drug when the same drug already exists through an FDA-approved manufacturer. That’s illegal.

•Check with your doctor if your drug label says it was compounded and you didn’t expect it to be.

• Think twice if prescribed a compounded version of a drug no longer on the market. Ask why it was taken off the market, and heed any safety concerns.

•Be informed about your drugs. Compounded medications may come without warning labels or information about side effects, but that doesn’t make them risk free. Ask your doctor and pharmacist how to use, store and discard medications correctly. Check the active ingredients on Web sites such as

•Pharmacists should ask a patient (particularly new ones) about their medical needs, medical history and all medications and supplements they use. "The pharmacist should have an in-depth conversation with you. However, if you get an aggressive sales pitch from a pharmacist, beware," Herold says.

•Although no compounding permit is needed to compound general medications in California, pharmacists are required to have a special accreditation if they make injectable drugs. If you’re getting a compounded injectable, make sure your compounder has this special license.

•Check the California State Board of Pharmacy’s Web site at to make sure a pharmacy is licensed and in good standing. Check to see if an Internet pharmacy is recommended by the National Association of Boards of Pharmacy at If it’s on the "not recommended site," don’t use it.

•Find out if the pharmacy is accredited by the Pharmacy Compounding Accreditation Board,, which compounders established to certify pharmacies. It’s not necessarily a guarantee of quality, but it’s one indicator that the company takes compounding seriously and practices quality control.