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Asslamuallaikum miss my name is shillla hanifa from class a pharmacy, with

student id number is three double one two onezero four nine. Im here to fill out my
midterm is about making video of explain about over the counter (OTC)

Prescription and Over-the-Counter (OTC) Drugs


A drug is a substance intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease. Here are the maindifferences between OTC
drugs and prescription drugs.
Prescription drugs are:
· 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) rocess. 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 NDAincludes 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 NOTrequire a doctor's prescription
· Bought off-the-shelf in stores
· Regulated by FDA through OTC Drug monographs. OTCdrug monographs are a
kind of "recipe book" coveringacceptable 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 FDAclearance, while those that do not, must undergo separate
review and approval through the "New Drug Approval System."
there are my explanation about Over The Counter from chapter 4, for fulfillment
my English midterm Thank u for your attention, sorry if there are still many
mistakes because here, i'm also still learning.

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