What Is a 503b Compounding Pharmacy?

1What Compounding Means

Compounding is a process where medications are combined into a single pill, capsule, or formula. Patients who require a lot of different medications generally have a difficult time keeping track of which pills to take when. By combining them all into a single dose, everything is streamlined.

The Benefits of Compound Drugs

A pharmacist can create a compound drug customized for the patient’s individual needs, particularly for patients with allergies. Sometimes kids or elderly patients have trouble swallowing a pill. A compound pharmacist can combine their medications into a liquid form to work around that problem. Veterinarians often use compound drugs to create a single drug for a sick pet, as it can be quite difficult to give certain medications to animals.

The Process is Simplified

Doctors have less paperwork to fill out, as they don’t need to fill out multiple prescriptions for multiple institutions. With a single prescription, this also reduces the chances of an error or oversight. In general the customizable nature of compound drugs leads to a greater quality of care for patients.

503b Compounding Pharmacies

In 2013, the Food and Drug Administration created a set of guidelines to allow outsourcing facilities to create compound drugs. These compound pharmacies are regulated by the FDA and are subject to inspection on a staggered schedule. The facilities must register under section 503b of The United States Federal Food, Drug, and Cosmetic Act.

Obtaining Compound Drugs

Physicians often partner up with 503b compound pharmacies. The doctor can write a single prescription containing the doses of each required medication and send it off to the pharmacy. The pharmacy creates the drug in a clean room using FDA Approved Chemicals following the specifications of the physician. The drug is sent back to be delivered to the patient.

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