Quality

CHPA supports the U.S. Food and Drug Administration's (FDA) federal regulations ensuring and enforcing product quality for over-the-counter (OTC) medicine and dietary supplement manufacturers.

CHPA member companies continuously monitor the quality and manufacturing processes of their OTC medicines and dietary supplements. Federal regulations issued by FDA provide the regulatory framework for ensuring product quality, starting with the ingredients in these products and continuing through manufacturing, distribution, and the product’s expiration date. Compliance with federal regulations is evaluated by FDA via regular manufacturing facility inspections. Individual states may also have laws and regulations that impact manufacturing and set standards for product quality. A number of organizations also provide guidelines or standards for ensuring product quality. Taking all these laws and regulations into consideration, a manufacturer develops internal standard operating procedures to document their processes and ensure consistently high-quality products are produced for the marketplace.

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Comments to FDA: Initiation of Voluntary Recalls

Letter regarding the Healthcare Distribution Alliance position on the Draft Guidance for Industry: Initiation of Voluntary Recalls.

Jun 25, 2019

Browse Quality Content

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Press Releases and Statements

CHPA Files Amicus Brief with 9th Circuit U.S. Court of Appeals

This week CHPA filed an amicus brief urging the 9th Circuit U.S. Court of Appeals to confirm an appellate panel’s holding that a class in a class action lawsuit cannot be certified with more than a de minimis number of uninjured class members.

Sep 9, 2021

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Submission

Brief Amicus Curiae of CHPA in Support of Bumble Bee Foods LLC.

CHPA’s argues both constitutional precedent and federal rules on class action lawsuits require classes that capture members who actually have a viable claim and potential right to recovery; not classes in which some consumers are even plausibly harmed.

Sep 7, 2021

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Weekly Voice

CHPA Files Amicus Brief on Class Action Standards

CHPA this week filed an amicus brief urging the 9th Circuit US Court of Appeals to confirm an appellate panel’s holding that a class in a class action lawsuit cannot be certified with more than a de minimis number of uninjured class members.

Sep 7, 2021

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Press Releases and Statements

CHPA Will Feature FDA Leadership, Industry Experts During Virtual Regulatory Conference

Janet Woodcock, Cara Welch, other consumer healthcare leaders to discuss emerging trends in OTCs, dietary supplements, and consumer medical devices

Aug 12, 2021

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Weekly Voice

SHOP SAFE Act Bills Introduced in the Senate and House; House Judiciary Committee Holds Hearing on the Bill

Last week, Senators Chris Coons (D-Del.) and Thom Tillis (R-N.C.) introduced the Stopping Harmful Offers on Platforms by Screening Against Fakes in E-Commerce (SHOP SAFE) Act, intended to protect consumers by stopping the online sale of harmful counterfeit products. This follows introduction of the same legislation by House Judiciary Committee Chairman Jerrold Nadler (D-N.Y.) and Congressmen Darrell Issa (R-Calif.), Henry C. "Hank" Johnson, Jr. (D-Ga.), and Ben Cline (R-Va.).

Jun 3, 2021

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Weekly Voice

Senate Introduces INFORM Consumers Act

Senators Dick Durbin (D-Ill.) and Bill Cassidy, M.D. (R-La.) recently introduced legislation to combat the online sale of stolen, counterfeit, and dangerous consumer products by ensuring transparency of high-volume third-party sellers in online retail marketplaces.

May 5, 2021

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Press Releases and Statements

“Quality and Safety” Concerns Should Lead FDA to Withdraw Temporary Hand Sanitizer Manufacturing Guidance

In a new letter, ACI and CHPA call on FDA to withdraw its temporary guidance for the manufacturing of alcohol-based hand sanitizer products.

Apr 29, 2021

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Submission

Joint Letter to FDA Regarding Temporary Hand Sanitizer Guidance

The American Cleaning Institute (ACI) and the Consumer Healthcare Products Association (CHPA) request that FDA withdraw its Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).

Apr 28, 2021

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Weekly Voice

House Passes Safe Banking Act Once Again; Allows Hemp Manufacturers Access to Financial Institutions

This week, by a vote of 321-101, the House of Representatives passed H.R. 1996, the SAFE Banking Act. The SAFE Banking Act prohibits a federal banking regulator from penalizing a depository institution for providing banking services to a legitimate cannabis-related business.

Apr 20, 2021

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Press Releases and Statements

CHPA Statement on Unapproved Drugs Found in Fraudulent Sports and Weight Loss Supplements

CHPA released the following statement in response to new research published in Clinical Toxicology. The study found nine illegal stimulants, including deterenol, in fraudulently marketed sports and weight loss supplements.

Mar 23, 2021

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The Product Quality Research Institute (PQRI) is a non-profit consortium of that generates and shares timely, relevant, and impactful information to advance drug product quality and development. PQRI provides a unique forum to focus critical thinking, conduct research, exchange information, and propose methodology or guidance to pharmaceutical companies, regulators, and standard-setting organizations.

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