The Food and Drug Administration (FDA) recently issued a draft guidance, a final guidance, a proposed rule, and two revised nominations for the bulk drug substance lists. These documents are meant to clarify the FDA’s position on compounded products.
The draft guidance consists of guidelines regarding compounded products manufactured in outsourced facilities per Section 503B. It discusses the requirements for outsourcing facilities that manufacture compounded substances, such as how the facilities are to be designed. It mentions the purity standards (ISO Standards) for air circulating in rooms in which compounded products are manufactured. Steps and control systems that can be implemented to maintain those standards are also mentioned. It discusses procedures for maintaining the environment and monitoring the personnel who work in those environments. Methods of testing containers for these drugs are also discussed.
The final guidance discusses the guidelines for pharmacy compounding under 503A. According to the guidance, a drug compounded by a pharmacist or licensed physician is exempt from the regulations under Sections 501(a)(2)(B), 502(f)(1), and 505 of the Federal Food Drug and Cosmetic Act if it meets the requirements under Section 503A. Some of these requirements include being compounded for an individual patient by a pharmacist or licensed pharmacy on the basis of a valid prescription. Pharmacists can compound small amounts before receiving a prescription if they base the compounding on a history of receiving such prescriptions or if the patient is familiar to them. The drugs must also be compounded in accordance with the United States Pharmacopeia requirements. Bulk substances that are manufactured in a facility registered under Section 510 and that have a valid certificate of analysis for each drug substance are also subject to Section 503A. The compounded drugs should not appear on the list of withdrawn drugs.
Under the proposed rule, the FDA intends to revise its list regarding the drugs that cannot be compounded as a result of being withdrawn from the market because of poor safety or efficacy. This list would include twenty-five new drugs and modify the description of one currently on the list to include an exception. This revision is a result of new information that has become available since the FDA first issued the list fifteen years ago. The FDA is also planning on withdrawing an alternate version of the list that it had issued previously. This list would apply to manufacturers who directly produce a drug and to outsourcing facilities.
The first nomination consists of a list of bulk substances that can be used to compound a drug according to Section 503A, even those that are not subject to the United Stated Pharmacopeia or the National Formulary or are components of approved drugs. Although the FDA allowed manufacturers to submit the names of bulk substances in December of 2013, many of these substances did not qualify or sufficient information was not included. Therefore, the FDA is planning to revise the list.
The second nomination consists of a list of bulk substances that can be used to compound a drug according to Section 503B. As with those submitted for the first nomination, the FDA allowed manufacturers to submit the names of bulk substances. However, the amount of information provided was insufficient. Therefore the FDA is reopening the submission process and providing more specific information regarding what they need.
Manufacturers will be able to provide input on the draft interim guidance and proposed rule to the FDA over the next sixty days. They can also provide input on the list nominations over the next ninety days. With help from manufacturers, the FDA can draft guidances, rules, and lists that will help to make their position on the use of compounded substances more clear.
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For Further Reading
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403507.htm
https://www.federalregister.gov/articles/2014/07/02/2014-15367/bulk-drug-substances-that-may-be-used-to-compound-drug-products-in-accordance-with-section-503a-of
https://www.federalregister.gov/articles/2014/07/02/2014-15373/bulk-drug-substances-that-may-be-used-to-compound-drug-products-in-accordance-with-section-503b-of