McGuff Compounding Pharmacy Services, Inc. is licensed throughout the United States of America. As such, we are bound to follow not only federal regulations but also individual states’ rules regarding pharmacy compounding. These regulations are quite different for compounded products than they are for commercial products. Physicians are often perplexed at these regulations and are surprised at the legal challenges that McGuff must follow. Here are examples of some of those legal challenges:

• Multiple states do not allow the shipment of compounded medications for in office use.
• Multiple states require the shipment of compounded products pursuant only to a patient prescription.
• Potency assays of compounded injectable products are mandatory prior to shipping to certain states.
• A Pharmacist-In-Charge must be licensed and designated in the particular states where McGuff compounding pharmacy is licensed as an out-of-state pharmacy.

In addition, many physicians, and even some compounding pharmacies, are not aware that the Food and Drug Administration (FDA) has a list of drugs that are prohibited for pharmacy compounding. If a drug appears on that list, we will not compound it.

The FDA has also published guidelines for compounding pharmacies to follow. These are general rules the FDA will utilize to support their decision that a pharmacy has "crossed the line" and has become a manufacturer that must meet all current good manufacturing practices. McGuff Compounding Pharmacy is a conservative pharmacy that desires to retain its standing as a pharmacy. You may sometimes find we do not compound certain medications other pharmacies do. In these situations you can be assured our pharmacy is working within the FDA guidelines and is protecting both our and your rights to compounded medications.

Pharmacy compounding is an ever developing field, and regulations governing its practice continue to evolve. McGuff is committed to following federal and states regulations in the best interests of not only the pharmacy but also for our doctors and patients.