Page 10 - Reference Guide For Foreign Pharmacy Licensing Exam Theory
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The law also provides more incentive to innovative pharmaceutical companies and encourages them to develop
new drugs.
NATIONAL DRUG CODE NUMBER (NDC)
The NDC generally consists of ten to eleven letters.
1. The first four characters indicate the name of the manufacturer or distributor.
2. The middle four characters identify the drug name and strength.
3. The last two characters identify the package.
National Provider Identifier Standard (NPI)
The National Provider Identifier (NPI) is a Health Insurance Portability and Accountability Act (HIPAA)
Administrative Simplification Standard.
The NPI is a unique identification number for covered health care providers. Covered health care providers and
all health plans and health care clearing houses must use the NPIs in the administrative and financial
transactions adopted under HIPAA.
The NPI is a 10-position, intelligence-free numeric identifier (10-digit number). This means that the numbers do
not carry other information about healthcare providers, such as the state in which they live or their medical
specialty.
The NPI must be used in lieu of legacy provider identifiers in the HIPAA standards transactions.
OVER THE COUNTER DRUG
The FDA classifies OTC drugs into three different categories.
Category I: It includes ingredients generally considered to be safe, effective and not misbranded.
Category II: It includes ingredients that are not considered to be safe or effective, or are misbranded.
Category III: It includes ingredients for which data are insufficient to permit their classification.
PATIENT PACKAGE INSERT
The FDA passed this law in 1970. The law states that a patient must be provided with the supplement drug
information, commonly known as Patient Package Insert or PPI, by a pharmacist while dispensing certain drugs.
The list of such drugs are:
1. Isotretinoin
2. Oral contraceptives
3. Isoproterenol
4. Ticlopidine
5. Progesterone
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