Labeling Requirements Flashcards
Label
Written, printed, graphic matter on the immediate container of any article which must appear on the outside of the container or wrapper of package or easily legible through outside container or wrapper
***Affixed to immediate container
Labeling
All labels and other written, printed, graphic matter on an article or its containers or wrappers or accompanying the article (like package insert)
***Anything packed with it, “accompanying”
(if not “accompanying” then its advertising)
Labeling Requirements for Manufacturer
Requirement failure = MISBRANDED Requirements: 1. Name or address of manufacturer, packer, or distributor 2. Name of drug (Generic and Brand) 3. Ingredients (and quantity/proportion) 4. Inactive ingredient names if not PO (w/exceptions) 5. Weight measure (100 mg) 6. Net quantity (100 tablets) 7. Recommended/usual dosage statement or reference to package insert 8. Lot/control # 9. Legend "Rx only" 10. Route(s) of admin 11. Storage 12. Expiration date
Unit Dose Packaging and Labeling
Each unit dose package:
- generic and brand name
- Manufacturer/packer/distributor
- Repackager’s lot #
- Expiration date
- Any other appropriate info
Adequate Information for Use
For RX drugs (not adequate directions like for OTC)
- For health care provider
1. Indications
2. AEs
3. Dosages
4. Routes, methods, frequency, duration of administration
5. Contraindications
6. Warnings/precautions
Labeling exemptions
- Rx drugs are exempt from labeling/packaging requirements of FDCA if dispensed pursuant to legit Rx issued by licensed practitioner to administer drug
- Exemption is only if processed, labeled, repacked on condition that such drug are not adulterated or misbranded
- Requirements (failure = misbranded) to dispense
1. written rx from licensed practitioner
2. oral rx reduced to writing and filed by pharmd
3. refill of written/oral rx if authorized by prescriber originally or by oral order reduced to writing and filed
Labeling Requirements for Pharmacist
Requirements to avoid misbranding
- Dispenser name and address
- Serial #
- Date of Rx or of its filling
- Prescriber name
- Patient name
- Sig
- Cautionary statements
Labeling Exemptions Do Not Apply
To:
- Dx done by mail or no legit RX by licensed practitioner
- Drug dispensed with false or misleading label
- Drug imitation
- Offered for sale under a different drug name
- Drugs subject to USP or HPUS packaging requirements
- Drugs needing packaging to prevent deterioration
- Drugs needing packaging to conform to PPPA
Package inserts
Informational for provider, not promotional, FDA approved Includes: -Drug description -Pharmacology -Indications, use -Contraindications -Warnings/Precautions -AEs -Potential for abuse/dependence -Sx and tx of OD -Dose and admin -Available dose forms -Date of current labeling revision -Recommended/usual dose
New Format Package Inserts 2006
- Highlights section: immediate benefits/risks, boxed warnings, indications, dose and admin
- Table of contents
- Initial product approval date
- Toll free and internet reporting info
- “Patient Counseling Information”
Black Box Warnings
Required for high risk drug for death/serious injury
Pregnancy Categories
A: clear evidence of no fetus risk B: animal studies showed no risk C: Undetermined risk D: positive evidence of risk E: Risk outweighs any possible benefit
OTC Labeling
- Identity
- Name and address manufacturer/packer/distributor
- Net quantity
- Cautions/warnings
- Adequate directions for use (for layperson to use safely)
- Drug facts panel
OTC Labeling: Adequate Directions for Use
- Conditions, uses, purposes
- Quantity or dose for each use, age, and physical condition
- Frequency
- Duration
- Time (meals, onset, etc)
- Route/method admin
- Preparation (shaking, etc)
OTC Labeling: Drug Fact Panel
- Active ingredients
- Purpose
- Use
- Warning
- Directions
- Other info as required
- Inactive ingredients alphbetical
- Questions? Comments w/phone #
