PRESENTATION
INTRODUCING GROUP 2
Adinda aulia
Nur Fadhilah I Kartini
ramadani
Prescribed by a doctor
Bought at a pharmacy
Prescribed for and intended to be used by one person
Regulated by FDA through the New Drug Application (NDA) process. This is the formal
step a drug sponsor takes to ask that the FDA consider approving a new drug for
marketing in the United States. An NDA includes all animal and human data and
analyses of the data, as well as information about how the drug behaves in the body
and how it is manufactured. For more information on the NDA process, please see
"The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective
OTC DRUGS ARE
• Drugs that do NOT Bought off-the- •Regulated by FDA through OTC Drug
require a doctor's monographs. OTC drug monographs are a kind
shelf in stores
prescription of "recipe book" covering acceptable
ingredients, doses, formulations, and labeling.
Monographs will continually be updated adding
additional ingredients and labeling as needed.
Products conforming to a monograph may be
marketed without further FDA clearance, while
those that do not, must undergo separate review
and approval through the "New Drug Approval
System.
b.Answers the questions based on the text
5. The three main jobs of a pharmacist are hospital pharmacist, retail or community
pharmacist, and industrial pharmacist.
6. In the sentence, "They must also ensure an adequate supply of medicine". "they"
refers to hospital pharmacists.
7. The phrase "obat bebas" (over-the-counter drugs) means medications that can be
purchased without a prescription.