Should I get my Medicines from a Compounding Pharmacy?
The truth about compounded prescription drugs
I am often asked by patients whether or not they should go to a compounding pharmacy for their medicine. I have to admit that I was not informed about the truth of compounded medicines until I operated on a pharmacist who happened to own a reputable compounding pharmacy in Los Angeles. I was enlightened by our conversation to learn both the myths and realities of this type of pharmacy.
One type of prescription medication that causes many people to hesitate when it comes to compounding is bio-identical hormones. This usually occurs when a female patient asks me about taking bio-identical hormone replacement therapy (BHRT) to treat menopausal symptoms. The patient was told by their treating physician that the medicines is unavailable at a retail pharmacy and it is a “customized” formulation only available at a compounding pharmacy. While manufacturers claim that BHRT drugs are identical to the hormones naturally produced by the human body, these claims have not been verified by the FDA. Unfortunately, many manufacturers report unsubstantiated claims about the effectiveness of BHRT compounded drugs. While some compounding services may claim to provide BHRT drugs, these substances are not proven effective for their intended use, and they cannot prevent or cure any diseases. Most menopausal hormone therapy prescriptions are FDA-approved and clinically proven to provide relief from the symptoms of menopause, but BHRT drugs use untested and unverified substances. There is no scientific evidence that proves BHRT drugs are safe or effective. Additionally, the long-term effects of BHRT use are generally unknown, and pharmacies typically aren’t required to report adverse reactions to BHRT medications. Compounding offers customization to prescription medications, but this typically comes at a relatively higher price as compared to FDA- approved prescription medicines covered by insurance or Medicare.
What is compounding?
Compounding describes the practice of combining prescription medications in a controlled environment. Compounded drugs are NOT FDA-approved. Because compounded drugs are not FDA-approved, the FDA does not verify their safety, effectiveness, or quality before they are marketed. In addition, poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much or too little of the active ingredient. This can lead to serious patient injury and death.
Why do some patients need compounded drugs?
A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form. Practitioners in hospitals, clinics, and other health care facilities sometimes provide compounded drugs to patients when an FDA-approved drug is not medically appropriate to treat them. In these situations, compounding can serve an important patient need. However, some compounders engage in activities that can put patients at risk and/or undermine the drug approval process. For example, FDA has observed that some compounders have made false and misleading statements that compounded drugs are safe and effective, sometimes for the treatment of serious diseases, by incorrectly suggesting the drugs had met the standard for FDA approval.
What are the risks associated with compounded drugs?
The FDA has observed troubling conditions during many of its inspections of compounding facilities including toaster ovens used for sterilization, pet beds near sterile compounding areas, and operators handling sterile drug products with exposed skin, which sheds particles and bacteria, among many others. Compounding drugs under insanitary conditions could lead to widespread patient harm, especially when the compounder engages in large-scale, non-patient specific compounding and distribution. The FDA may not be aware of which compounders are making such drugs, and some states may have insufficient resources to adequately oversee them.
Who can compound drugs?
Compounding commonly occurs in pharmacies, although it may also occur in other settings. Federal law addresses compounding by a licensed pharmacist in a state-licensed pharmacy, or federal facility, or by a physician, as well as compounding by or under the direct supervision of a licensed pharmacist in an outsourcing facility. Outsourcing facilities are a category of compounders established in 2013 by the Drug Quality and Security Act. Outsourcing facilities are inspected by the FDA according to a risk-based schedule and are subject to increased quality standards.
Who inspects facilities that compound drugs?
Generally, state boards of pharmacy have primary responsibility for the day-to-day oversight of state-licensed pharmacies that are not registered with FDA as outsourcing facilities. FDA does conduct surveillance and for-cause inspections of state-licensed pharmacies that are not registered as outsourcing facilities. Facilities that register with FDA as outsourcing facilities under section 503B are primarily overseen by FDA and inspected by FDA according to a risk-based schedule.
What quality standards apply to compounded drugs?
Quality requirements for compounded drugs differ depending on the setting where compounding occurs. Drugs compounded in outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements. By contrast, drugs compounded by a licensed pharmacist in a state-licensed pharmacy, or federal facility, or by a physician, in accordance with the conditions of section 503A of the FD&C Act, are exempt from compliance with CGMP requirements. These facilities may be subject to less stringent quality standards set in state law or policy. Such standards may differ state to state. However, regardless of where compounding occurs, whether in a pharmacy, outsourcing facility, or physician’s office, other federal requirements apply, including the requirement that drugs not be prepared, packed, or held under insanitary conditions.
When ordering compounded prescription drugs is necessary, it’s vital to use a trusted compounding operation with a proven track record of customer satisfaction and commitment to providing safe and effective compounded medications.
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