It really doesn't help us at all since it did nothing to enforce the purity of supplements from the stupidity of the Dietary Supplement Health and
Education Act of 1994 (DSHEA).
https://www.mdlinx.com/endocrinology/washington-report/2017/06/27/7228653?
Silver Spring, MD, June 27, 2017––The following is a statement from FDA Commissioner Scott Gottlieb, MD, regarding the Drug Quality and Security Act:
"In late 2012, the United States faced the most serious outbreak
associated with contaminated compounded drugs in recent history,
involving hundreds of people, in many states, who developed fungal
infections related to a compounded product. It was an incident that
resulted in dozens of deaths.
"The fungal meningitis outbreak underscores the need for robust
oversight over human drug compounding, the importance of dispensing
prescription drugs pursuant to valid prescriptions, and the need for
strong coordination with state regulatory partners to protect public
health.
"Since that outbreak and the subsequent enactment of the Drug
Quality and Security Act (DQSA) on Nov. 27, 2013, the FDA has devoted
significant resources to oversee compounding and implement the
compounding provisions of the law. As of June 1, 2017, the FDA has
conducted more than 400 inspections, including 109 inspections of
outsourcing facilities; issued more than 150 warning letters advising
compounders of significant violations of federal law; issued more than
50 letters referring inspectional findings to state regulatory agencies;
overseen over 125 recalls involving compounded drugs; and worked with
the Department of Justice on a number of civil and criminal enforcement
actions.
"As part of the implementation of DQSA, we have also issued 21
draft guidances, 10 final guidances, three proposed rules, a final rule,
and a draft memorandum of understanding. We have taken a risk–based
approach to all of these efforts, in order to make sure that we are
maximizing the public health purpose of these new provisions relative to
the resources we use to achieve them, and any obligations that these
new requirements place on market participants. These foundational
regulations and guidance documents provide predictability and
transparency to compounders, providers, and other enterprises; and
inform them of how to comply with the law’s provisions in the most
efficient manner.
"These efforts are part of our commitment to doing all we can to
protect the public from poorly compounded drugs. We will continue to
actively oversee drug compounders and, when appropriate, initiate
regulatory action as it fulfills the FDA public health mission on behalf
of patients."
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