In the United States, there are approximately 56,000 community-based pharmacies. Around 7,500 of these are compounding pharmacies. Compounded medicines are gaining popularity in the United States. These medicines offer new therapeutics that are not sold by major drug companies.
But what is a compounded medicine and why do people take them? We’ve got your answers in this helpful guide.
What Are Compounded Medicines?
A compounded medicine is a drug that is created by a licensed pharmacist for you. Your doctor will write a compound prescription when other drugs do not meet your exact needs. Compound prescriptions are taken to a special compound pharmacy. These medicines are prepared as to your doctor’s specifications.
Like a baker makes a cake, a compound pharmacist mixes in the active ingredients. The correct amounts of each ingredient make up the compounding prescription. The result is a compounded medicine that fits your unique needs.
Why Are Compounding Pharmacies Necessary?
Sometimes doctors write compounded prescriptions for a patient. A particular patient may not be able to tolerate all the components of a commercial drug. A compounded pharmacist can mix the medication. They leave out any components that could be harmful.
When drugs are discontinued or hard to find a compounding pharmacy can create it for you. This is helpful to patients who are on medicines that seem to always be in short supply.
Compounding pharmacies can make a medication that is prescribed by your doctor for a therapeutic that may not be commercially sold. New medications have helped grow compounding pharmacies in the United States.
Here are some examples of how a compounding pharmacist can customize your medication.
- Remove nonessential ingredients such as lactose, gluten, or dyes
- Customize the dose, strength or flavor
- Creates liquid medications instead of pills
How Is This Different From a Regular Pharmacy?
Compounding law excludes pharmacists from making copies of a brand-name drug. These are drugs that you can get at a regular pharmacy. Traditional compounding pharmacies prepare compounded medicines to your doctor’s specific requests. Compounding pharmacies do not make that medicine available to anyone other than you.
Regular pharmacies dispense mass-produced medications that are manufactured by large drug companies. These are specified by your doctor and created only for you. Name-brand drugs are the same pill that everyone gets.
You can not alter the dosage or remove ingredients you might be allergic to in a name-brand drug.
Compounding Pharmacies Explained
Many pharmacies offer some level of compounding. A pharmacy that offers flavors for children’s medicine offers a compounding service. Compounding pharmacies (such as this compounding pharmacy) investment in equipment and training. This investment ensures safety when they create your compounded medicine.
Compounding pharmacies must provide a sterile environment. Some drugs they make are intended for use in the eye or injected into the body.
A compounding pharmacist uses tools that are not available at regular pharmacies. Tools include a mortar and pestle for grinding materials, cylinders for measuring liquids.
All licensed pharmacists receive compounding training during their education. All pharmacists can perform basic compounding.
Only compounding pharmacists prepare compounded drugs for patients prescribed by doctors. Many hospitals and health care facilities compound their medicines.
Who Regulates Compounding Pharmacies?
Compounding pharmacies are regulated by your state’s board of pharmacy. The FDA does not regulate community and hospital-based compounding pharmacies. They are exempt under the Federal Food, Drug, and Cosmetic Act of 1938 if they meet regulations.
Just because they are exempt doesn’t mean that there isn’t any oversight of compounding pharmacies. All compounding pharmacists and pharmacies are overseen by state and federal authorities.
Compounding pharmacists follow strict standards and regulations for each medication that they create. The FDA also oversees the safety of drugs used to create compounding medications.
The Drug Enforcement Agency (DEA) oversees controlled substances used to make compounded medications. These include the making of narcotics.
The United States Pharmacopeial Convention, or USP, issues standards that apply to compounded medicines. USP defines the chemical purity of drugs. They issue standards for quality and strength. Compounding pharmacists ensure their final product is up to the standards.
Who Inspects Compounding Pharmacies?
Many different entities inspect compounding pharmacies. The FDA and your state board of pharmacy both play a role in the inspections. Your state board of pharmacy handles the day-to-day oversight of these facilities.
The FDA will conduct surveillance and inspections if concerns are raised about pharmacies. Compounding facilities registered with the FDA are overseen by the FDA. The FDA leads these inspections.
Are Compounding Pharmacies Accredited?
Yes, compounding pharmacies are accredited by the Pharmacy Compounding Accreditation. This is a service of the Accreditation Council for Health.
The Pharmacy Compounding Accreditation assesses sterile and non-sterile compounding pharmacies. They also make sure the medications they produce are of high-quality and consistent.
How Do I Know If I Received Compounded Medicines?
It’s simple. Ask your doctor or your pharmacist. When your doctor writes a prescription ask if it is prepared at a compounding pharmacy. Choose a compounding pharmacy to prepare your compounded medications.
It is an accepted practice for compounding pharmacies to label medications as compounded medicines.
When your doctor prescribes a compounded medication visit a pharmacy. Ask your local compounding pharmacy if they are accredited. Compounding pharmacies are available online through the Pharmacy Compounding Accreditation Board’s website.
You are also welcome to ask about your pharmacist’s training. Ask if the pharmacy is registered with the FDA.
Compound Pharmacies Make Life Easier
Compounded medicines are becoming more common. Any doctor can write you a compounded prescription to fit your unique needs. Compounded medications make life a lot easier by accommodating allergies, strengths, and dosages.
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