AS I SEE IT
There are thousands of potential combinations of compounded medica- tions, and because it is costly to create a compound and meet all of the compli- ance requirements, we in the compound- ing industry tend to focus on a relatively limited offering of compounded prod- ucts. For example, compounded phar- macies might focus primarily on non- sterile or sterile drugs and further focus on particular medical specialties, such as urology or pain management. The back-ordered medication process
done correctly is time-consuming and a bit of a gamble from our perspective. We must consider how long the medication might be on back order and weigh that against the time we would have to invest and the expenses we would have to incur to compound the medication to deter- mine a reasonable market price for the medication. For sterile injectable medi- cations, we also have to consider the time our products will be under quarantine as we await our sterility and endotoxin (pyrogen) testing, which is required by California and some other states and ac- creditation bodies. Once we determine that a medication
is truly on back order and is projected to continue to be on back order for some time, our operational team follows this standard operating procedure: ■
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source all of the ingredients from an FDA-sanctioned supplier;
identify the appropriate packaging materials required for the medication;
develop the beyond use dates (BUD) for the medication;
quantify the use of the medication with our customers so this can be tied to the production process;
fill the order and test the medication with outside laboratories; and
ship and deliver the medication in the most efficient manner. Finally, after completing all of the steps described above, we must ensure
Questions to Ask When Choosing a Compounding Pharmacy for Your ASC
1. What licenses does your compounding pharmacy have in place? A retail license? A sterile license? A non-resident license if they are mailing into your state?
2. What is the focus of the pharmacy? What is the depth and level of experience of the management team and clinical staff on compounding sterile medications?
3. Do they follow US Pharmacopeia guidelines for testing of potency, endotox- ins and sterility? What proof can they give you of this?
develop a formula that will be used to make the medication, sometimes this requires testing of the formulation;
4. Do they follow the Drug Enforcement Administration’s constructive transfer law, meaning that if they ship you controlled sterile injectables, it constitutes less than 5 percent of their business? Can they prove that? If not, are they shipping those medications to the patient directly?
5. Are you in a state that limits office use versus patient-specific prescriptions? There are 15 states that significantly limit or exclude office use. What steps does your compounding pharmacy take to ensure that you are compliant?
6. What processes are in place for sterile production? Are all sterile injectables produced in certified clean rooms and under sterile powder and laminar hoods? If you ask to see a copy of their standard operating procedures for sterile production, could you see one?
7. If someone from your ASC is interested in making a site visit to the the phar- macy, will they be accommodated?
8. How does the pharmacy stay up-to-date with state, US Food and Drug Ad- ministration and Drug Enforcement Administration laws?
9. What is the pharmacy’s process for ensuring that it isn’t copying commer- cially available drugs unless they are on back order?
10. Can the pharmacy accommodate “patient-specific” instead of “office use” prescriptions?
ASC FOCUS JUNE 2013 9
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