All pharmacists and pharmacies involved in compounding are subject to oversight by both federal and state authorities.
The practice of compounding is regulated by state boards of pharmacy. FDA has oversight for the integrity of the drugs (called Active Pharmaceutical Ingredients, or APIs, by the FDA) used in compounded preparations. The Drug Enforcement Administration (DEA) has oversight for any controlled substances used in the preparation of compounded medications. Controlled substances include narcotics such as hydrocodone, amphetamines and similar drugs, and certain drugs used for anxiety and sleep disorders.
Additionally, the United States Pharmacopeial (USP) Convention issues standards that apply to compounding. This organization defines the chemical composition of drugs and also issues practice standards. We have been trained in and strictly adhere to <USP 795> and <USP 797> techniques and practice standards.
The Pharmacy at St. Michaels is very conscientious about the chemicals we use in our compounds. We use an FDA registered American distributor that subjects their chemical lots to 14 checks and analyses prior to being shipped to our pharmacy. These checks include:
This ensures we receive safe and quality chemicals so we can make you safe and quality compounded prescriptions.
What is Compounding?
Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are “made from scratch” – individual ingredients are mixed together in the exact strength and dosage form required by the patient. This method allows the compounding pharmacist to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs.
Some areas we compound for:
replacement therapy (BHRT)
Otic (for the ear)
What can the pharmacist at The Pharmacy at St. Michaels compound?
With a prescription from your physician, some of the things our pharmacist can do are:
Adjust the strength of a medication
Avoid unwanted ingredients such as dyes, preservative, lactose, gluten, or sugar.
Add flavor to make the medication more palatable
Make a drug that has been discontinued.
Prepare medications using unique delivery systems. For patients who find it difficult to swallow a capsule, our compounding pharmacist may prepare the drug as a flavored liquid suspension instead. Other medication forms include topical gels or creams that can be absorbed through the skin, suppositories, sublingual troches, or gummies.