Complya News

2017 First Quarter Final Guidance Highlights

During the first quarter of 2017 and the FDA has issued a number of drafts and final guidances that effect the pharmaceutical, medical device, and compounding industries. Complya Consulting Group, would like highlight the key final drafts issued in the first quarter of this year.

January 10, 2017

cGMP requirements for Combination Products (21 CFR part 4)

Issued By: OC, CBER, CDRH, CDER, ORA

A combination product is a therapeutic and diagnostic product that combines two or more regulated components (i.e. drug, device, and/or biological products) to produce a single entity whether the components are physically or chemically combined, packaged together or packaged separately; where the components are to be used tougher to achieve the intended use. (21 CFR 3.2 (e)). The final rule on cGMP requirements for Combination Products was issued on January 22, 2013, however prior to this final rule the regulations did not clarify the application of cGMP requirements for combination products since these products cross the lines of the FDA’s medical product centers; CBER, CDER and CDRH. The last draft guidance was issued January 2015 and has been finalized as of January 10, 2017 and is intended to explain the final rule on CGMP requirements for combination products and to specify how to compliance with the applicable CGMP requirements may be demonstrated.

For more information about Combination Products:
https://www.fda.gov/CombinationProducts/default.htm

Reference:
https://www.fda.gov/RegulatoryInformation/Guidances/ucm126198.htm

January 13, 2017

Interim Policy on Compounding Using Bulk drug Substances Under Section 503A and 503B of the FD&C Act

Issued by CDER

FDA is developing a list of bulk drug substances (“503A Bulk List” and “503B Bulk List”) that can be used in compounding under the section 503A and 503B of the FD&C Act, respectively.   For the time being this guidance outlines the FDA’s interim regulatory policy for licensed pharmacists in State-licensed, Federal facilities and for licensed physicians that compound human drug products using bulk drug substance. Bulk drug substances are “the same as active pharmaceutical ingredient as defined in 21 CFR 207.1(b).” The active pharmaceutical ingredient is “any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body,” (503A(b)(1)(A) and 21 CFR 207.3).

Reference:
503A: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm469120.pdf
503B: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm469122.pdf