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April 22, 2013

What Is A Compounding Pharmacy?

compounding pharmacyA compounding pharmacy specializes in the preparation of customized medications for patients. This contrasts to the mass production of drugs by pharmaceutical companies. Compounding drugs is as old as the practice of pharmacy with records dating back to 2,000 BC. So the compounding of drugs is not new.

Most of us are used to going to the pharmacist at the local drugstore and picking up our prescribed medications. That concept is actually relatively new considering that pharmaceutical companies did not begin mass production of medications until the 1950s or so. Prior to that the pharmacist actually prepared an individual’s medications.

The art of compounding almost became extinct once the pharmaceutical companies started to mass produce conventional drugs. But, compounding has made a comeback in recent years to better meet the needs of patients unable to be met by pharmaceutical companies. Today compounding pharmacies largely fill a void left by pharmaceutical companies.

What is Compounding?

Compounding is the custom making of a drug for a specific individual based on a written prescription by a physician. Big drug companies make medications in large volumes but in relatively limited dosages. Pharmaceutical drugs are made in advance of a prescription being written.

Compounded drugs are not made until a prescription has been written for a specific patient. Compounded drugs are customized for the individual patient. Compounding pharmacies know the name, phone number, and address of the end user of their product. Pharmaceutical companies have no idea who ultimately will be using their drugs.

Compounded drugs are made on demand. They are not made in advance and sitting on a shelf awaiting usage like commercially available pharmaceutical drugs.

Most patients and even physicians do not realize that a vast majority of chemotherapy agents are compounded. Such drugs have to be made individually taking into account a patient’s weight and sometimes liver and kidney function.

Also, any IV bag used in a hospital that has anything added to it like potassium, an antibiotic, or other medications like dobutamine is a compounded product that is being customized for a specific individual.

Why Consider a Compounding Pharmacy?

Medications mass-produced by pharmaceutical companies typically come in a limited number of dosage strengths and usually are only available in pill form. Though, some do come in a topical or injection form. Some individuals have special needs that cannot be met by the limited doses and delivery systems offered by the big drug companies.

In addition, some patients may be allergic to one of the inactive ingredients contained within a pharmaceutical produced drug. Thus a compounding pharmacy can prepare drugs in different strengths and any number of delivery forms and avoid the need for inactive ingredients (dyes and fillers).

Here is an example. Celebrex is an non steroidal anti-inflammatory and comes in 100 mg and 200 mg capsules. If a patient obtains good relief from 200 mg but has gastrointestinal side effects, and the 100 mg turns out not to be effective without side effects, a physician can ask a compounding pharmacy to compound a 150 mg capsule to see if it will be effective without side effects.

Or, Celebrex could be compounded into a topical form that can be applied over a painful joint like the knee, thus avoiding absorption through the gastrointestinal tract and side effects that might accompany such absorption.

The oral route of taking a medication for most problems is actually the least effective way of delivering drug as much of it is metabolized before it exerts its effects. Therefore, higher dosages of drugs have to be used. A compounding pharmacy can make drugs that can be taken sublingual, transdermally, and in a rapid dissolve form using smaller doses to get the desired effect. Compounded drugs can be made in suppository form, sprays, rinses, and even lollipop form depending a patient’s need.

What Can be Compounded?

Nearly any drug can be compounded that is not patent protected and commercially available. A compounding pharmacy cannot compound a patented drug in the dosages made by a drug’s manufacturer. Going back to Celebrex, a compounding pharmacy cannot make a 100 mg or 200 mg capsule of Celebrex as those doses are patent protected.

Bioidentical hormones are probably the most compounded of the compounded drugs. But, medications for chronic pain management, chemotherapy, and infertility are frequently compounded. Only ingredients or substances that are FDA approved can be compounded. For instance, a compounding pharmacy cannot compound Vioxx or Bextra that are no longer FDA approved.

Are Compounding Pharmacies Regulated?

There is much confusion on the regulation of compounding pharmacies. Many doctors are confused on this point as well and many are critical of compounded drugs because they are not FDA approved not realizing that the IV bags they order in the hospital and the many chemotherapy agents they prescribe are compounded products and are not FDA approved either.

First, compounding pharmacies are regulated at the state level and also have to meet some federal requirements. Compounding pharmacies can only use FDA approved ingredients in their preparations and there are restrictions regarding the source (country of origin) of such ingredients.

It is true that compounded medications are not FDA approved. But, there is a simple explanation why compounded drugs are not FDA approved that most doctors do not know.

For a drug to be FDA approved the manufacturer has to prove or demonstrate to the FDA that a dose of medication falls within a limited range. In other words, if a medication is to be 100 mg the pharmaceutical company has to demonstrate to the FDA that the medication contains 100 mg (or very close). Dosages are easy to verify when pills are massed produced (take a few off the assembly line and spot check them so to speak).

It is not so easy to verify doses for the thousands and thousands of customized compounded drugs made each day. The FDA would have to have a physical presence in every compounding pharmacy, which is obviously not practical.

Plus, how do you verify the dose of drug customized for a specific individual without destroying the drug for that patient’s utilization? The same is true with chemotherapy agents and IV bags.

When a doctor writes for an IV bag containing 0.45 normal saline with 40 milliequivalents of potassium there is no way to no know for sure (without destroying the sample) that there is 40 milliequivalents of potassium in that IV bag. That 40 milliequivalent has to be manually added to the IV bag by the hospital pharmacy.

Thus, compounded chemotherapy agents and IV bags are not FDA approved either. But, no one, including doctors takes issue with prescribing or using such compounded products.

Thus, compounded drugs are not FDA approved because of logistical bureaucratic reasons. Not, because they are unsafe.

In summary, a compounding pharmacy fills a very important void not met by pharmaceutical companies by customizing drug dosage and delivery systems to better meet the specific needs of specific patients in response to a specific written prescription from a physician.

You now know more about compounding pharmacies than most physicians.

Updated 6/17/16.


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Dr. Joe Jacko

Dr. Joe is board certified in internal medicine and sports medicine with additional training in hormone replacement therapy and regenerative medicine. He has trained or practiced at leading institutions including the Hughston Clinic, Cooper Clinic, Steadman-Hawkins Clinic of the Carolinas, and Cenegenics. He currently practices in Columbus, Ohio at Grandview Primary Care. Read more about Dr. Joe Jacko

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