Compounding is an old tradition of preparing medicines specifically to meet a particular patient's individual needs. In other words, with compounding, medications can basically be personalized for you.
Compounding can modify a medication:
- To any desired dosage amount or
- Into a different form. For example, turning a hard-to-swallow pill into a patch or an injectable drug, or making it into a lollipop.
All compounds are based on a doctor's prescription. Your insurance company may even pay for all or part of a compounded medication.
Compounding is regulated on the state level, not by the FDA - even though the drugs being compounded are approved by the FDA. (The rationale is apparently that compounding does not create a new drug).
If you are considering a compounded product: ask your doctor whether there is a standard FDA approved drug available in a form that is ready to be administered (even if it costs more).
If you do need a unique prescription that requires compounding, follow these guidelines recommended by Cynthia Reilly, director of the practice development division for the American Society of Health-System Pharmacists: (plus ask any other questions you think are relevant)::
- Choose a pharmacy carefully.
- Start with recommendations - including from your medical team.
- Check to be sure that the pharmacy is licensed by the state and that it has not been penalized. Compounding pharmacies are regulated by state boards of pharmacy. (For contact information, see: http://www.hapnetwork.org/medicare-drug-coverage/state-boards-of-pharmacy.html )
- Check to see whether the pharmacy is accredited by the independent Pharmacy Compounding Accreditation Board (PCAB). PCAB offers its official seal of approval to pharmacies that voluntarily pass strict inspections and other rigid requirements. See www.pcab.org
- Ask about the training of the pharmacists.
- Ask whether the pharmacy had additional accreditation.
- Visit the facilities for yourself and see if they seem clean and safe.
- Ask the pharmacy whether it is familiar with your prescription and has experience preparing it.
- Ask for directions about storing and using the product.
- Inquire about side effects, risks and contraindications.
- Check the FDA website for warning letters about lack of compliance. (Keep in mind that the FDA only has limited authority over compounding pharmacies.) See: www.fda.gov
To find a compounder, consider the following alternatives: