Company: PRGO
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001585364-25-000014
Chunk: 332

Company: PERRIGO Co plc
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 332
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 withdrawal or recall.

OTC

All of our drug products are manufactured, tested, packaged, stored, and distributed according to current Good Manufacturing Practice ("cGMP") regulations. The FDA performs periodic inspections and/or records audits to ensure that our facilities and quality systems remain in compliance with all appropriate regulations and agency expectations. Specific regulations and laws that impact our business include, but are not limited to: 

•The FDCA gives authority to the FDA to oversee the safety of food, drugs, medical devices, cosmetics and other items. Following the 2012 enactment of the Food and Drug Administration Safety and Innovation Act, the FDCA incorporated, among other things, new user fee collection authority for prescription drugs. Since that time, user fee authority has been extended to OTC drugs, generic drugs and biosimilars and to additional supply chain parties. 

•The FDCA is regularly modified by Congress in other ways, including modifying FDA’s authority regarding drug and device shortages and enhancing the FDA's inspection authority of the drug supply chain. 

•The FDA Reauthorization Act of 2017 created a pathway by which the FDA may, at the request of an applicant, designate a drug with “inadequate generic competition” as a Competitive Generic Therapy.

•Public Health Service Act, as amended (PHS Act) The Public Health Service Act (PHSA) regulates biologics through Section 351, which outlines the requirements for the approval, licensing, and oversight of biological products. 

API

Third parties develop and manufacture APIs for use in certain of our pharmaceutical products that are sold in the U.S. and other global markets. API manufacturers typically submit a drug master file to the FDA that provides proprietary information related to the API manufacturing process. The FDA inspects the manufacturing facilities to assess compliance and the facilities and procedures must be compliant before API may be imported into the U.S. Currently, API must also be associated to an active or approved FDA application in order to be imported into the U.S. unless it meets certain exemptions.

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Perrigo Company plc - Item 1Business

Medical Devices

We are subject to the Medical Device Amendments of 1976 to the FDCA and its subsequent amendments in the U.S. The regulations issued thereunder provide for regulation by the FDA of the design, manufacture and marketing of medical devices, including some of our products marketed under our oral care and OTC businesses. All of our current medical devices fall under Class I or Class II of the regulations. These devices are also subject to other general