Are compounded medications approved by the FDA?
The FDA was created in the 1930′s for the express purpose of regulating manufacturers who produce drugs that would be distributed to the mass population. Compounding pharmacists do not mass distribute and are regulated by individual state laws. The chemicals used by compounding pharmacies are obtained from FDA inspected and approved facilities.
Aren’t FDA products safer and more effective?
Not necessarily. FDA approved manufacturers have drug product recalls often. These recalls range from wrongly packed and mislabeled medications to improper potency to ineffective and dangerous medications. These recalls can affect thousands of people. Two recent examples of drug product recalls for safety are Rezulin and Propulsid. A recent example of a recall for incorrect packaging is MS Contin. Duragesic patches were most recently recalled for a manufacturing defect.
Why don’t all pharmacies compound prescriptions?
Most do. According to the American Pharmacy Association and the National Association of Community Pharmacists, compounding is done to some degree in 90% of all hospital pharmacies and 80% of all independent pharmacies. All pharmacists are permitted by law to compound as part of the practice of pharmacy; however, compounding pharmacists have learned skills above and beyond those they were taught in school. Compounding also requires a substantial commitment on the part of the pharmacy owner of time (each prescription is individually made in the pharmacy, not just transferred from one bottle to another) and money (for additional training and purchase of the specialized equipment that is required to make a quality product). There are now about 400 compounding only pharmacies in America, and many more in countries around the world. Compounding quality does vary along with the skill of the compounding pharmacist, and has an excellent safety record.
What about quality control?
A good compounding pharmacy like Pharmacy Innovations has in place stringent quality control procedures, some of which include sterile product testing and environmental controls. Detailed records should be kept for each and every compound. With detailed records, the lot number and expiration date of each chemical used can be traced if needed.
Why are there so few studies on compounding?
The majority of large studies are funded by drug manufacturers who are required to do so by the FDA in order to get a particular product approved for mass marketing. Some drugs (human hormones, for example) cannot be patented; therefore, there is no monetary incentive for any company to pay for an expensive drug study. Furthermore, there are published studies done for many ingredients used in compounded products.
Will human hormones eventually prove to be as dangerous as synthetics?
The hormone questions will always be with us. Hundreds of compounding pharmacists, thousands of physicians, and millions of patients believe that human hormones, in normal body ratios and amounts, are both safe and healthy. Many believe that hormone replacement therapy can help both women and men live longer and healthier lives. The key is to work with your health care provider and your compounding pharmacist to find the unique balance that is right for you.
Do you accept insurance?
We participate with many insurances. Please contact us to find out if we participate with your plan.