Labeling Requirements Flashcards
(T/F) Nonprescription drugs must bear the name of place of business of the manufacturer, packer, or distributor
True
The person who performs all of the following operations that are required to product the product:
- Mixing
- Granulating
- Milling
- Molding
- Lyophilizing
- Tableting
- Enapsulating
- Coating
- Sterilizing, and
- Filling sterile, aerosol, or gaseous drugs into dispensing containers
Manufacturer
What are the requirements for nonprescription drug labeling?
- Name and place of manufacturer
- “Drug Facts”
- “Active Ingredients”
- “Purpose”
- “Uses”
- “Warnings”
- Normal dose for each intended use and doses for individuals of different ages/or physical conditions
- Frequency and duration of administration or application
- Administration or application in relation to meals, onset of symptoms, or other time factors
- Route or method of administration
- Any required preparations for use
- “Other information”
- Required information about certain ingredients in OTC drug products
- “Inactive ingredients”
- “Questions”
What are example warnings that can be on nonprescription drugs?
- “For ______ use only”
- “Do not use” followed by all contraindications
- “Ask a doctor before use if you have”
- “Ask a doctor or pharmacist before use if you have”
- “When using this product” followed by the side effects that the consumer may experience, and the substances or activities to avoid while using the product
- “Stop use and ask a doctor if” (needs to have a toll-free number which consumers can report complaints to the manufacturer or distributor of the drug product)
- Any required warnings in an applicable OTC drug monograph
- The pregnancy/breast-feeding warning
- “Keep out of reach of children”
- “Directions”
How do drugs that are both OTC and RX differ?
Differences in the indication for use and sometimes different in strengths
What is the panel of a label that is most likely to be displayed, presented, shown, or examined by the end user on prescription drug labels?
Principal display panel (PDP)
What information should the principal display panel have?
- Name, logo, and place of business of manufacturer, packer, or distributor
- NDC number
- Proprietary name, established name of proper name
- Generic name
- Ingredient information including quantity and proportion of each active ingredient; names of inactive ingredients
- Quantity in terms of weight of measure
- Net quantity of container
- Recommended or usual dosage or reference to package insert
- Route of administration
- Warnings or cautionary statements
- Rx-only statement (legend)
- Expiration date
- Statement specifying type of container to be used in dispensing
- Bar code/control number/lot number
What are strips of individual cells or sheet that are usually small and often torn apart, punctured, or removed from outer carton?
Unit dose blister packs
What information should each blister cell label have when possible?
Proprietary and established name, strength, lot number, expiration date, bar code and manufacturer
What is alternative acceptable method of labeling blister packs?
Random display of the information can appear multiple times across the back of the blister, or the important information should be displayed so that it is not destroyed or eliminated when dosage units are removed
(T/F) The blister carton labeling should describe the milligram amount of drug per single unit
True
What is the pamphlet that must accompany the drug product and contains the essential scientific and medical information needed for safe and effective use of the drug by health care professionals?
Package insert
What are the four significant changes made to the PI?
- New section called Highlights for immediate access to the most important prescribing information about benefits and risks
- Table of Contents
- Date of initial product approval
- Toll-free number and internet reporting information for suspected adverse events
Items in PI:
- Highlights of prescribing information
- Product names, other required information
- Boxed Warning
- When use of drug may lead to death or serious injury, the FDA may require the warning of the special problem in a prominently displayed box
- Recent major changes
- Indications and usage (1)
- Dosage and administration (2)
- Dosage forms and strengths (3)
- Contraindications (4)
- Warnings and precautions (5)
- Adverse reactions (6)
- Drug interactions (7)
- Use in specific populations (8) (such as pregnancy, labor and delivery, nursing mothers, pediatric use, geriatric use)
- Drug Abuse and Dependence (9) - controlled substance, abuse, dependence
- Overdosage (10)
- Description (11)
- Clinical Pharmacology (12) - MOA, pharmacodynamics, pharmacokinetics
- Nonclinical toxicology (13) - carcinogenesis, mutagenesis, and impairment of fertility, animal toxicology and/or pharmacology
- Clinical Studies (14)
- References (15)
- How Supplied/Storage and Handling (16)
- Patient Counseling Information (17)
How many digits are in an NDC number?
10 digits, 3 segments (5-4-2), unique number (11 digits for billing)
