Regulatory Focus™ > News Articles > 2021 > 3 > HHS proposes updates to patient labeling, BA/BE study regulation

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Posted 30 March 2021 | By Kari Oakes 

HHS proposes updates to patient labeling, BA/BE study regulation

2794 The US Department of Health and Human Services (HHS) has released its semiannual inventory of proposed rulemaking actions, with a relatively brief to-do list for drug and medical device regulators.
For the US Food and Drug Administration (FDA), actions sitting at the proposed rule stage include an amendment to 21 CFR 320 to clarify FDA’s expectations for the conduct of analytical and clinical pharmacology as well as bioavailability and bioequivalence studies to support marketing applications for drugs and biologics. The proposed rule would also debut 21 CFR 321 to address details of these issues.
“The proposed rule would specify needed basic study conduct requirements to enable FDA to ensure those studies are conducted appropriately and to verify the reliability of study data from those studies,” according to HHS. The goal for this action would be to achieve better international regulatory harmonization as well as alignment with other FDA regulations and industry practice.
Another proposed rule addresses patient labeling, calling for a new kind of label called “Patient Medication Information” for prescription drugs and some blood products that are meant for outpatient use. “The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively,” according to HHS.
At the final rule stage, a pair of rules addresses the sale, distribution and use of sunlamps that are regulated as general and plastic surgery devices and tweaks the performance standard for these devices. The updated performance standard would now be harmonized with those of the International Electrotechnical Commission. The second rule would apply stricter device restrictions to sunlamps, which HHS says may cause up to 400,000 cases of skin cancer yearly.
HHS is also proposing to finalize changes FDA is recommending for the 503A bulk substances list. Five additional substances are proposed to be added, while 26 substances will not make their way onto the list after FDA considered and rejected their inclusion.

“Additional substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking,” wrote HHS.  (RELATED: Glycolic acid, TCA among proposed additions to 503B bulk drugs list, Regulatory Focus 30 July 2020; FDA recommends 503B bulks list addition; rejects HCQ sulfate, Regulatory Focus 24 March 2021)

Federal Register



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