첨부 파일은 2021년 8월 3일에 개최된 "미국(OTC Drug) 수출 웨비나"의 교육자료입니다.

아래 링크에서 강의 녹화 영상을 보실 수 있습니다.

https://www.youtube.com/watch?v=ikw-R1DETCo

교육자료의 목차는 아래와 같습니다.

- What is an OTC monograph product? (plus examples)

- How OTCs are Drugs, and what that means to companies

- FDA and its responsibilities for OTCs

- Company responsibilities

• Manufacturer (product filler)

• Brand owner (product marketer)

- Registration/notification to FDA

- Ingredients for OTCs

- Labeling of OTCs

- FDA inspections

• Overseas facilities inspections (yes, they really do happen)

• How to prepare

- Enforcement

• Penalties

• Warning letters

• Import alerts