With the increase in the number of off-patent drugs released into the market, pharmacies have started to look into bulk compounding in order to save money. Specific active pharmaceutical ingredients (APIs) are not approved individually by the FDA, but a bulk drug may be created by a manufacturer that is certified under the administration. For pharmacies, there are several benefits1 associated with utilizing APIs during the compounding process.
In the event that approved dosages are being used, pharmacies can eliminate the need to identify active ingredients and initial doses because the information is already provided by the manufacturer. The elimination allows pharmacies to compound drugs, save time and improve overall efficiency in the creation process.
The Use of Bulk Drugs in Sterile Compounding
Approximately 80 percent of APIs originate from foreign facilities, according to the National Association of Boards of Pharmacy.2 It can be difficult to trace their origins, and cases of contamination and inaccurate dosages have been logged by the FDA. However, government organizations have created several standards to protect compounding pharmacies from these pitfalls.
For example, the USP and FDA now collaborate to evaluate existing monographs and identify any contamination before APIs are used in the compounding process. The NABP also works with the FDA to help state inspectors evaluate APIs on a local level.
Under existing legislation, APIs must now come from FDA-registered facilities not under FDA enforcement action before a pharmacy can guarantee a compounded drug’s safety. Purchase orders and receipts must also be available to trace an API’s origin.
Aside from the regulatory benefits, there are also financial advantages for sterile compounding pharmacies that choose to utilize APIs. For example, the interchangeable use3 of these products from generic manufacturers can reduce overall cost. APIs can typically be purchased at a fraction of the price of other pre-manufactured products.
Depending on the amount of off-patent drugs being produced, it may be beneficial for a sterile compounding pharmacy to introduce APIs to save money. However, each situation varies according to the pharmacy at hand.
The FDA and Bulk Drug Substances
The FDA addressed the use of bulk chemicals with an interim policy on compounding in October 2015.4 This publication pertained to the use of bulk drugs under Section 503B of the Federal Food, Drug and Cosmetic Act.
Section 503B includes restriction on bulk substances that can be used in outsourcing facilities – the same facilities being turned to by drug manufacturers to reduce production costs. The two conditions specified by the FDA:
- The bulk substance being used must appear on an approved list established by the administration.
- The drug product compounded from the bulk substance must appear on a drug shortage list in effect under Section 506E at the time of compounding, distribution and dispensing.
Approximately 190 substances are being considered for the 503B list. The FDA is also working on a final interim guide for the use of bulk substances at outsourcing facilities.5
Perhaps the largest advantage for bulk sterile compounding pharmacies is cost management. When a pharmacy chooses to utilize these chemicals, they have the option of shopping around for the best provider of the generic ingredient. This ultimately gives it control over the amount of money spent on sterile compounding and production.
- Sellers, Sarah. Utian, Wulf. Pharmacy Compounding Primer for Physicians. U.S. National Library of Medicine. Published December 25, 2012. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3695671/
- Gozun, Edisa. “Current Topics in Pharmacy Compounding.” NABP.net. Retrieved February 23, 2016. https://www.nabp.net/meetings/assets/FDA%20Update.pdf
- Peacock, Gina. “Pros and Cons of Using Bulk Chemicals to Compound.” International Journal of Pharmacy Compounding. Published December 20, 2012. https://compoundingtoday.com/Newsletter/Science_and_Tech_1212.cfm
- “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug and Cosmetic Act.” FDA. Published October 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf
- “Bulk Drug Substance Lists.” FDA. Retrieved February 26, 2016. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM446240.pdf