Compounding primer for the General Public:
What is compounding: Simply stated, compounding is the art of making customized medication products by hand. Compounding services can be divided into three categories.
1) Simple compounding: Simple compounding is the making and fixing of commercially available medical products, or raw chemical powders, from one strength or form into another strength or form, that is not commercially available. For example, a tablet can be crushed and used to make a suspension. Raw medicinal chemicals can be turned it into a capsule, cream, ointment, suppository, or syrup. Commercially available creams can be mixed together to make a combination specific for patients. Also, flavoring a medication is considered compounding.
2) Hazardous Compounding: Much like simple compounding except for the fact that the products made are considered Hazardous Substance's to the worker who is manipulating the powders and chemicals. The Hazardous Substances are listed on a data base called the NIOSH list for health care workers ( National Institutes of Occupational Safety and Health ). This list is an recording of drugs that can pose hazards to the health care worker who manipulates or administers the drug, and as such must take precautions to protect the worker from deleterious/harmful effects due to exposure. Specific to compounding, the act of crushing pills, capsules, or manipulating raw powders that can be inhaled or that can affect the skin due to contact calls for a special Hazardous Materials laboratory, employee training, protective gear, and special ventilation. Chemo therapeutic agents, radioactive drugs, and most commonly any and all bioidentical hormones such as testosterone, progesterone, estrogens, estradiol, estriol, thyroid hormones, liothyronine, and levothyroxine are all considered Hazardous materials .
These new safety requirements have caused many pharmacies to make a major investment to be able to safely compound these products. Many pharmacies that once used to compound these products no longer do so due to the capital investment, or physical limitations of their current facility. Willow Bend Pharmacy used to compound Bio-Identical Hormones. However, new federal regulations limit our ability to continue that service due to space limitations at our current facility. If we ever build a new facility in the future, we will include a hazardous materials lab and once again offer this service.
3) Sterile Compounding: Sterile Compounding involves making and preparing medications in a sterile environment in such a way that the end product is sterile and able to be administered into the body free of pathogens and contaminants. These products can be hazardous materials like testosterone injection or commercially available products like IV solutions. The emphasis in sterile compounding is less on worker safety and more on patient safety. The design flow of the laboratories needed are directly opposite of what is needed in Hazardous Compounding. Sterile compounds can be administered to the eye, ear, nose, or be injected or infused into the body or body cavities to include the spine, bladder, or venous system.
As you can see, to be a well rounded compounding pharmacy, a facility would need three work areas and two complete labs. Few pharmacies have both, and fewer are nationally certified (2% of compounders). National certification is not a requirement but I would seek out the services of certified pharmacies over non-certified if I was needing a sterile injection. Because of the cost and space requirements, pharmacies that offer these complex services can be very busy. Also, the medications are typically expensive and have poor insurance coverage.
At big box chain pharmacies some pharmacists will do simple compounding to include flavoring syrups for children, mixing two creams together, mixing three suspensions together as mouthwash, or preparing a compound from a commercial kit.
At our pharmacy we do simple compounding. We can make capsules, suspensions, creams, ointments, or solutions for both humans and pets. I can list a variety of formulations that we have made but if you're looking for a specific product, it's easier to give me a call and ask if we can make it. If I cannot, I will direct you to several pharmacies locally that have the product equipment and expertise. We make about 2-4 simple compounds a day. Simple compounding products also has little to no coverage by insurance. However they can be cheaper than the hazardous or sterile compounding products due to the lower overhead.