Compounding pharmacy refers to combine, mix of substances or alteration of dosage form or strength or delivery system of a medicinal product tailored to the needs and quantity of an individual; includes the combination of two or more compounded preparation or substances. But compounded drugs are not FDA-approved.
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 summary, a compounded preparation should be prepared only in circumstances when:
- A registered product is unavailable in the market.
- A registered product with similar therapeutic effect is unavailable in the market.
- A registered product is unsuitable (e.g. if a patient experiencing allergy to an excipient in the registered product).
- When undertaking research sanctioned by a recognized human research ethics committee.
- A treatment requires tailored dosage strengths/forms for patients with unique needs (for example, an infant).
Compounded preparations should only be provided if the preparation is safe and appropriate for an individual. The compounded preparation should be prepared in reference to international pharmacopoeias or references recognized by Regulatory Authority, and must not be on testimonials and impressions.
What are the risks associated with compounded drugs?
As per FDA, 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.
Responsible Person
Compounding preparation shall be done by a responsible person as stated below:
- A pharmacist or a person working under the immediate personal supervision of a pharmacist.
- A person acting in the course of his duties who is employed in hospital or dispensary maintained by the Federal or any State Government.
- A fully registered medical practitioner or a dental practitioner or a veterinary practitioner or a person working under the immediate personal supervision of such a practitioner if the drug in question is for the use of such practitioner or of his patient.
In the compounding activity of medicinal products, overall control is essential to ensure that the consumer receives quality products.
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