What is compounding?

Compounding is the method of preparing customized medications to help the physician meet the patient?s needs.
Customized medications improve therapeutic outcomes and compliance by solving the problems.

What is the difference between commercially available drugs and compounded medications?

COMPOUNDING

• Creating the formula for the individual patient

MANUFACTURING

• No specific patient in mind when drug is produced

COMPOUNDING

• Making the formula match the patient’s need

MANUFACTURING

• Matching patients to the product

COMPOUNDING

• Administer the drug to the sight of action in
  the most effective dosage form available

MANUFACTURING

• Economic considerations limit choices in drug dosages and dosage forms

When is compounding appropriate?

Route of administration

A medication may only be commercially available as an oral or injectable product but we can often simplify home administration for someone who is NPO by compounding an alternate route of administration, such as a transdermal gel.

Combination of medications

It is often possible to combine several medications into a single oral dosage form, such as a capsule, troche, or a transdermal cream/gel, or a suppository.

Flavoring

Often, we find that terminally ill patients are unable to tolerate sweetness, but would prefer a medication that is flavored like coffee, for example. We can flavor each medication to suit the individual’s palate, and eliminate aftertastes.

Dosage modification

We can compound a medication that contains the most appropriate strength of medication to provide therapeutic benefit and avoid/minimize adverse effects.

Dosage form

Can be altered to meet the patient’s need. Suppose it is most desirable to continue oral administration but the patient has difficulty swallowing. With consideration given to particle size, solubility, and stability, we can properly compound a solution or suspension. How about a freeze-pop or lollipop? These are particularly useful when it is desirable to prolong medication contact with the oral cavity.

What is the legal support for compounding?

The FDA recognizes compounding as viable and legal. As practicing medicine is a combination of science and art, compounding allows health care practitioners to be creative while adhering to FDA regulations.
Congress listed 3 criteria for using pharmaceutical ingredients in compounding:

• The pharmaceutical ingredient is a component of an FDA approved product.
  
• The pharmaceutical ingredient has a USP/NF monograph.
  
• The pharmaceutical ingredient is published on a list of ingredients approved for use in compounding.

When considering pharmaceutical ingredients FDA would consult with USP and the FDA advisory committee and use the following criteria:

• The chemical characterization of the substance;
  
• The safety of the substance;
  
• The historical use of the substance in pharmacy compounding;
  
• The available evidence of the substance’s effectiveness or lack of effectiveness, if any such evidence exists.