There is always a case where a specialty prescription needs to be filled that would not normally be bought through a pharmaceutical manufacturer. This is where Family Pharmacy strives to excel with the services they provide to communities. Family Pharmacy is certified & equipped with all of the special compounding tools which aids in the filling of prescriptions that are not readily available at any pharmacy.
What is Compounding?
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?
Compounded drugs can serve an important medical need for patients, but they do not have the same safety, quality, and effectiveness assurances as approved drugs. Unnecessary use of compounded drugs unnecessarily exposes patients to potentially serious health risks.
Because compounded drugs are not FDA-approved, 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 active ingredient. This can lead to serious patient injury and death.
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. FDA may not be aware of which compounders are making such drugs, and some states may have insufficient resources to adequately oversee them.
In October 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history. A pharmacy in Massachusetts shipped compounded drugs that were contaminated with a fungus throughout the country, and these drugs were injected into patients’ spines and joints. More than 750 people in 20 states developed fungal infections, and more than 60 people died. Approximately 14,000 patients received injections from the lots of contaminated drug product. See 2012 Fungal Meningitis Outbreak: Persons with Fungal Infections Linked to Steroid Injections, by State, Centers for Disease Control and Prevention for more information.