Compounding describes the practice of combining prescription medications in a controlled environment. Licensed pharmacists, physicians, or outsourcing facilities perform compounding under close supervision to create medications tailored to individual patients. Many patients take several medications or have sensitivities to certain compounds, additives, or other medications, and therefore need a more customized approach to their prescriptions. But are compounding pharmacies safe?
Common Misconceptions About Compounding
Technically, compounded drugs are not approved by the Food and Drug Administration (FDA), the oversight agency responsible for ensuring safe and effective drugs in the United States, but they are overseen by professionals in the pharmaceutical industry. Pharmacy state boards oversee the daily operations of all pharmacies, including compounding pharmacies, which are regulated by the FDA.
The idea that compounding pharmacies aren’t overseen by federal administration is not accurate. Additionally, under section 503A of the FDCA, the FDA has some authority over their operations. When you work with a compounding pharmacy, there are oversights in place to patrons.
How Can I Know What I’m Getting?
The FDA ensures no compounding operation may mislabel or misrepresent compounded medications and their ingredients.
Patients are also protected by state boards of pharmacy, which ensure compounded medications are only available with legitimate prescriptions.
Most compounding operations have a local network of doctors and pharmacies that work together to provide compounding services to residents in the area.
Is Compounded Medication ‘Alternative Medicine’?
Compounded medications are not alternative medicines.
While most alternative medicines claim to be natural remedies or are scientifically unproven treatments, compounding is simply customized prescription medications. Although pharmaceuticals provide relief and medical condition management for countless patients, some people still have difficult sensitivities to certain drugs or may not be able to take the preferred treatment due to a drug allergy or other issue.
Are Compounded Drugs More Dangerous?
Typically, compounded prescription medications are actually safer for patients as long as they use reputable, licensed compounding operations. While mass-produced pharmaceuticals may not pose any issues to the majority of patients, some patients who might otherwise benefit from taking those drugs cannot for various reasons. Compounding allows patients to take valuable medications in appropriate doses and omits potentially harmful additives, filler substances, dyes, or other substances.
Understanding Bio-Identical Hormone Replacement Therapy (BHRT)
One type of prescription medication that causes many people to hesitate when it comes to compounding is bio-identical hormones. 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. It’s essential to verify the effectiveness of any compounded drugs, and only secure them through licensed, reputable channels.
How Are BHRT Drugs Different from Menopausal Hormone Therapy (MHT) Prescriptions?
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.
Aren’t BHRT Drugs Safer than MHT Drugs?
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.
Many people require carefully tailored hormone therapy, and compounding offers a fantastic solution, but it’s vital to work with reputable compounding operations that use verifiable substances in their compounded drugs.
Can I Get Compounded Medications Without a Prescription?
Compounded medications still require prescriptions from licensed physicians. State boards of pharmacy manage the processes for obtaining and disbursing compounded medications, and no legitimate compounding operation would provide compounded medications without a prescription from a real doctor. Doctors play an important role in securing effective compounds, because they can help patients identify the elements of typical drugs that may cause adverse side effects for them. Doctors and patients typically work together when securing compounded prescription drugs to ensure the highest degrees of safety and effectiveness are followed.
How Does the Government Regulate Compounding?
While compounded drugs are not FDA-verified, the FDA still oversees compounding operations to ensure they meet the necessary regulations and guidelines for compounding. If a compounding operation fails to meet these requirements or violates their obligations under the FDCA, they are then subject to all the requirements for conventional manufacturers. This means that non-compliant manufacturers must then pay for the verification and testing necessary for FDA approval before resuming business.
Are Compounded Drugs More Expensive?
Compounding offers customization to prescription medications, but this typically comes at a relatively higher price.
Choose The Compounding Pharmacy of America
While many people may hold some common misconceptions about compounded drugs, it’s important to separate myth from reality and consider the value of custom-compounded prescription drugs. Some people who suffer from drug sensitivities, allergies to certain substances found in mass-produced pharmaceuticals or allergies to dyes and filler ingredients find tremendous relief thanks to compounding operations.
When ordering compounded prescription drugs, 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.
The Compounding Pharmacy of America meets the strictest regulations to ensure patient safety and order accuracy. The Compounding Pharmacy of America is fully accredited, through the Accreditation Commission for Health Care, and fully licensed to operate in several states.
Chief Operating Officer, The Compounding Pharmacy of America
Matthew Poteet, Pharm.D. graduated with Honors from Lee University with a Bachelors of Science in Biological Science. After his undergraduate training, he completed the Doctor of Pharmacy program at Mercer University Southern School of Pharmacy, graduating in 2004. Dr. Poteet has spent much of his pharmacy career on staff at two of the most prestigious academic teaching hospitals in the Southeast; Emory University in Atlanta and Vanderbilt University Medical Center in Nashville. At these institutions he received extensive experience and training in sterile products compounding.
He returned home to East Tennessee in 2010, where he has held the position of Pharmacy Director at two sterile products pharmacies in Knoxville. Matthew lives in Knoxville with his wife, Chris. Dr. Poteet is Tennessee’s first Board Certified Anti-Aging Pharmacist by the American Academy of Anti-Aging Medicine.