Have you assessed your Quat and Chlorhexidine Hand Sanitizers/Washes/Scrubs and other drugs for Nitrosamines? The deadline has passed!

What are Nitrosamines? Nitrosamines are impurities that may be found in some drug products. These impurities are not expected to be harmful at low levels, but may increase the risk of cancer when ingested at higher levels over a long period of time. The FDA has set guidelines for over-the-counter (OTC) drug monograph and pharmaceutical [...]


UPDATE: On 11/09/2023, FDA released a notice that enforcement for product listing and facility registration requirements under MoCRA will be delayed by 6 months, making the new compliance deadline 07/01/2024. This update comes following delays to the release of the Cosmetic Direct platform.  As new cosmetic product regulation compliance deadlines are quickly approaching, SRC Senior [...]

Let’s Get Ready for MoCRA!

What is MoCRA? The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 was signed into law by President Biden on December 29, 2022 as part of the 2023 Consolidated Appropriations Act , H.R. 2617. This Act significantly increases the U.S. Food & Drug Administration (FDA)’s oversight of cosmetic and personal care products from the 1938 [...]

FDA 2023 OMUFA Fees

On March 24, 2023, the US Food and Drug Administration (FDA) announced its 2023 fees for OTC monograph drug facilities under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The Monograph Drug Facility (MDF) fee has increased by $1,975 from $24,178 last year and the Contract Manufacturing Organization (CMO) fee has increased by $1,316 from [...]


FDA Warning Letter Trends for Over-The-Counter Drugs

SRC monitors industry trends through frequent communication with regulating agencies, and review of warning letters and enforcement actions. From our monitoring of FDA Warning Letters, we have noticed some recent trends in FDA enforcement and interpretation of the regulations of over-the-counter drugs. Bob MacDonald, SRC’s VP of Regulatory Services provides a breakdown of these trends. [...]

Upcoming Deadline to Comply with State Requirements for Disposable Wipes

Legislation enacted by California, Illinois, Oregon, and Washington requires labels for disposable wipes to contain specific symbols and statements to clearly indicate they are not flushable. The intent of such legislation is to help consumers easily identify the difference between flushable and non-flushable wipes, ultimately protecting water quality and public wastewater systems. According to [...]


FDA 2021 OMUFA Fees

On March 26, 2021, the US Food and Drug Administration (FDA) announced its 2021 fees for OTC monograph drug facilities under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). This fee assessment was authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act which added a new provision to the Federal Food, Drug and [...]


FDA Issues Temporary Guidance for Manufacturing Hand Sanitizers

What You Need to Know: On March 20, 2020 (updated on April 15, 2020), FDA issued a temporary policy for the manufacturing of alcohol-based hand sanitizers during the COVID-19 public health emergency.  This temporary guidance only applies to the manufacture of hand sanitizers that use alcohol (ethanol) or isopropanol as the active ingredient. The following [...]