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41 Cards in this Set

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If a person unknowingly or unintentionally violate FDCA, are they held liable?
Yes, violations of the FDCA are strict and offenses occur regardless of the person's intentions or knowledge
What must a pharmacist make note of when repackaging medication?
That it complies with Sec 301(k) which states that the new label must conform to all FDA specifications, including maintaining identical information from the original package
Define: "recall"
An order from the FDA or drug manufacturer to remove a particular product.

Falls under three different classes
Define: "Class I recall"
"...when there is a reasonable probability that the product will cause serious, adverse health consequences or death."
Define: "Class II recall"
".. when the product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote."
Define: "Class III recall"
"...applied to products not likely to cause adverse health consequences."
Who is responsible for notifying sellers of a drug recall?
The drug manufacturer
Who is responsible for notifying consumers of a drug recall?
The sellers of the drug
What does Section 501 of the FDCA pertain to?
Describes outline for deeming whether a drug or device has been adulterated
Define: "Adulteration"
A drug is adulterated if it is...
1) Prepared, packed or held in conditions where it may have been contaminated
2) Exposed to a container that may have contaminated it
3) Manufactured under conditions that do not conform to current GMP

Mostly applies to manufactures.
Define: "GMP"
Good Manufacturing Practice
When is a pharmacy deemed to be a manufacturer?
When it repackages or compounds medications for dispensing under certain conditions.
Define: "Current Good Manufacturing Practice (cGMP)"
A set of regulations that establishes minimum requirements for the methods, facilities or controls used in the manufacture, processing, packaging or holding of a drug product
Define: "Tamper-Resistant Package"
"One having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occured."
Define: "Misbranding"
A false or misleading label on a product that may confound the consumer
What does Section 502 of the FDCA pertain to?
Describing the conditions in which a drug is considered to be misbranded
Are manufacturers currently required to state whether or not a drug is habit forming?
No, but they must provide the habit-forming characteristics in the package insert
Describe the important points of Sec 502(e) which discusses ingredient labeling on packaging
The name and quantity of each active drug must be clearly labeled in alphabetic order on the drug product
Describe the important points of Sec 502(f) which discusses adequate directions for use
A label must contain both adequate directions and warnings in a language that the layperson can understand.

Adequate directions for use typically pertain to OTC drugs
What are the requirements for "adequate" labeling of directions of use?
1) Quantity or dosage each use and age
2) Frequency of use/application
3) Duration of use/application
4) Time of use/application
5) Route for use/application
6) Preparation necessary for us (i.e. shaking)

Adequate directions for use typically pertains to OTC drugs
What are the requirements for "adequate" labeling of information for use?
1) Drug's indications
2) Side effects
3) Dosages
4) Routes, methods, frequency and duration
5) Contraindications
6) Other warnings and precautions

Adequate information for use typically pertains to prescription drugs
How does the FDA define of a drug is an imitation?
If it is..

1) Identical in shape, size and color
2) Similar or virtually identical in gross appearance
3) Similar in effect to controlled substances
List the requirements for nonprescription drug labeling
1) Statement of ID of product including name, generic name and intended action
2) Name & address of company
3) Net quantity of contents
4) Cautions and warnings
5) Adequate directions for use
6) Drug Facts Panel
What is required to be listed on the Drug Facts panel for nonprescription drug labeling?
1) Active ingredient, dosage unit and quantity per dosage unit
2) Purpose
3) Uses
4) Warnings
5) Directions
6) Other information
7) Inactive ingredients
8) Questions? or Questions and Comments with telephone number
Define: "Professional OTC Labeling"
Designed to provide information for practitioners to better describe symptoms or conditions for use.

Examples: "heartburn" or "sour stomach" in place of a more specific dx such as "...hyperacidity associated with.."
Why are some drugs labeled as both OTC and Rx?
It may have an indication that the FDA has deemed not suited for patient self care, in which it would be considered a prescription.

Additionally, the prescription form may be of a higher strength than the OTC, thus requiring more monitoring.
What is required for the Commercial Container Label?
1) Name and address of manufacturer, packer and distributor
2) Established name
3) Ingredient information
4) Inactive ingredient names
5) Identity statement (generic and proprietary names)
6) Quantity in terms of weight or measure
7) Net quantity of container
8) Statement of recommended or usual dosage
9) "Rx Only"
10) Route of administration
11) Identifying lot or control number
12) Pharmacist directed statement regarding proper packaging
13) Expiry date
What is required for the labeling of a unit dose drug?
1) Established name of the drug
2) Quantity of active ingredient in each unit
3) Expiry Date
4) Lot or control number
5) Name/Place of business of the manufacturer, packer or distributor
6) Any statements required by a compendia if an official drug
Define: "Package Insert"
This is a pamphlet that must accompany the drug product and contains essential scientific and medical information needed for safe and effective use of the drug by health care professionals. It cannot be promotional in nature, false or misleading.
What does the "Highlights" section of the package insert describe?
This is designed to make the information in the insert easier for the pharmacist to read. Typically it contains:

1) Boxed Warnings
2) Indications and Usage
3) Dosage and Administration
Define: "Black Box Warning"
An identifier required by the FDA in the package insert or on the box notifying when the drug may lead to death or serious injury.
What are the five categories of risk in pregnancy?
Category A -- More Safe
Category B
Category C
Category D
Category X -- Less Safe
Define: "Pregnancy Risk Category A"
Adequate and well-controlled studies have not demonstrated a risk to the fetus.

This does not mean there is no possibility of harm, merely that it is unlikely. Use "only if clearly needed"

Subject in studies: Human
Define: "Pregnancy Risk Category B"
Animal studies have failed to demonstrate a risk to the fetus, but there are not studies in women. Use "only if clearly needed"

Subject in studies: Animal
Define: "Pregnancy Risk Category C"
EITHER animal studies have shown an adverse effect on the fetus OR no adequate studies in women.

Use "Only if the potential benefit justifies the potential risk to the fetus"

Study subject: Animals
Define: "Pregnancy Risk Category D"
Positive evidence of fetal risk exists based upon data from studies in humans. The benefit of the drug may outweigh the overall risks.

The patient must be notified of the risks of the drug.

Study Subject: Humans
Define: "Pregnancy Risk Category X"
Studies in animals or humans clearly demonstrates fetal risk, and that risk outweighs in potential benefit of the drug.

Must state: "may cause fetal harm when administered to a pregnant woman."

Study Subject: Humans or Animals
Define: "National Drug Code (NDC)"
How drug products are identified and reported using a unique 11-digit, 3- segment number (55555-4444-33).

Older drugs may omit a leading zero in one of the segements (55555-444-33)
What are the identifiers of the three segments of an NDC?
Example NDC - 12345-6879-00

12345 - A code that identifies the manufacturer or distributor

6879 - Code that identifies a specific strength, dosage form and formulation for a particular firm

00 - Code which identifies package size and type of drug
Define: "Seizure"
Term used to describe then the FDA physically steps in and stops the distribution of a drug or product
What is the difference between a "recall" and a "seizure"?
In a seizure, the FDA directly steps in to remove a drug from the market.

In a recall, the FDA notifies the manufacturer that they have to initial a removal of the drug from the market. The FDA can step in and do this themselves, but typically this is not the case.