Compounding pharmacies, through the dispensing of customized medications, provide important treatments that can have a dramatic impact on one's health and well-being. Selecting the right pharmacy may mean the difference between getting the right or wrong medication. Here are some important considerations when evaluating a compounding pharmacy.
Compounding pharmacies are not regulated by the FDA and therefore are not required to meet the same strict manufacturing criteria as drug manufacturers. Instead, they are regulated by individual state boards of pharmacy. Depending on the state, there are varying degrees of oversight on compounding practices.
That being said, pharmacies that have good procedures, top-of-the-line equipment, and continual quality control can make a compounded medication that rivals a mass produced pharmaceutical in its potency and purity. Therefore, it is important to critically evaluate the compounding pharmacy you are going to use to make sure that your medication is going to be of high quality.
Here are some questions you may want to ask a compounding pharmacy when deciding whether to use their services to fill your medication:
- What kind of equipment is used? If you are getting a cream, is the cream run through an ointment mill and some sort of homogenizer? The ointment mill pulverizes the active ingredients, making them micro-sized and improving penetration through the skin. A homogenizer or electric mortar and pestle will mix the cream at high speed so that every teaspoonful will have the exact same amount of active ingredient as every other. All compounded creams must be run through these two pieces of equipment to be high quality.
- Does the pharmacist have a relationship with my doctor, and if not, is the pharmacist willing to forge a relationship with him or her? Compounded prescriptions require a much higher level of communication between the pharmacist and the prescriber than conventional medications do. Good, open communication between your pharmacist and prescriber will help ensure that you are getting the appropriate medication in the appropriate way.
- Is the pharmacist easily accessible to answer questions? Not only does compounding require close communication between the pharmacist and the prescriber, it also requires close communication between you and the pharmacist. Choose a pharmacy where you feel the pharmacist is available to talk and listen to you when you have any concerns or questions. This, again, will help ensure you get the right medication and use it the right way.
- Does the pharmacy send out samples to get tested on a regular basis? This is called "skip-lot testing," and it is the only way for a compounding pharmacy to know if their products are what they say they are. Ask your pharmacy if they send out samples to be tested and how often. Busier pharmacies should send them out more often than slow ones.
- Does the pharmacy consistently make medications that meet the required standards of purity? The government generally requires that the purity of a compounded drug be within 10% of the labeled strength. Some compounding pharmacies go further and make sure that their products are within 2-3% of the labeled strength. Ask to see a pharmacy's certificates of analysis on the products that they test.
- Is the pharmacy accredited? This is something new to the world of compounding pharmacy. The body that accredits pharmacies is called PCAB (Pharmacy Compounding Accreditation Board). You can learn more about them at www.pcab.org. PCAB accreditation signifies that a pharmacy has well-documented policies and procedures, thorough employee training, and a system of rigorous quality control. Koshland Pharm is proud to be PCAB accredited. To learn more about quality assurance at Koshland Pharm, visit our Quality Assurance web page (click here for link).
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