FDA OTC Monograph Reform: What the CARES Act Changed for Foreign Drug Manufacturers: Guide for South Africa Exporters

Drug manufacturers in South Africa, particularly in Johannesburg, Cape Town, are increasingly targeting the US market. With key products such as wine, citrus fruits, rooibos tea, South Africa has significant potential in the American market. However, to legally introduce products into the US, companies must strictly comply with US Food and Drug Administration (FDA) regulations. This article details the FDA requirements related to this topic for South Africa businesses.

Administrative orders replacing notice-and-comment rulemaking

FDA regulations in this area apply to all foreign manufacturing facilities that wish to market products in the US. For drug manufacturers in Johannesburg and Cape Town, compliance is not only a legal requirement but also a prerequisite for maintaining business relationships with US import partners. If requirements are not met, shipments can be held at the port, denied entry, or even placed on the FDA import alert list.

OMUFA user fees and the exclusivity mechanism

To export drug to the US, South Africa companies need to: register their facility with the FDA, obtain a DUNS number from Dun & Bradstreet, appoint a US Agent with a US address, and ensure product labels comply with FDA regulations. For products such as wine, citrus fruits, rooibos tea, additional requirements may apply depending on the specific product type. FDABridge helps South Africa companies complete the entire process.

FDABridge supports South Africa exporters

FDABridge specializes in helping drug companies in South Africa complete FDA registration from start to finish. Our services include consulting, DUNS number registration, US Agent provision, FDA facility registration filing, and periodic renewal. Contact us today at fdabridge.com to get started.