The highlights of this presentation covers importance of drug labeling, general labeling provisions, labeling requirements for prescription drugs and/or insulin, labeling requirements for over-the-counter (OTC) drugs, exemptions from adequate directions for use, and labeling claims for drugs in drug efficacy study.

1. 21 CFR Part 201
Labeling of Drugs
Marwah Zagzoug
Good Clinical Practices
10-08-2006

2. Background
Importance of Drug Labeling
General Labeling Provisions
Labeling Requirements for Prescription Drugs and/or Insulin
Labeling Requirements for Over-the-Counter Drugs
Exemptions From Adequate Directions for Use
Labeling Claims for Drugs in Drug Efficacy Study
Content:

3. Background
• In recent years, there has been an increase in the
length, detail, and complexity of prescription drug
labeling, making it harder for health care practitioners
to find specific information and to discern critical
information.
• Therefore, the FDA placed regulations governing the
content and format of labeling for prescription drug
products.

4. Importance of Drug Labeling
• A prescription drug product’s FDA-approved labeling is a
compilation of information about the product, which must be
approved by the FDA, based on the agency’s thorough analysis
of the new drug application (NDA).
• The labeling contains information necessary to consider the
product safe and effective for use.
• These labeling regulations make it easier for health care
practitioners to access, read, and use information in prescription
drug labeling.
• They also enhance the safe and effective use of prescription
drug products and reduce the number of adverse reactions
resulting from medication errors due to misunderstood or
incorrectly applied drug information.

5. General Labeling Provisions

6. General Labeling Provisions
Drug labels are generally expected to
contain the following:
• Drug name
• Name and place of business of manufacturer,
packer, or distributor.
• Statement of ingredients
• Expiration date
• Lot number

7. General Labeling Provisions
(continued)
• Adequate directions for use
– Statement of all conditions, purposes, or uses drug
is intended for
– Quantity of dose
– Frequency of administration
– Duration of administration
– Route or method of administration
– Preparation for use (i.e., shaking, dilution,
adjustment of temperature, or other)

8. General Labeling Provisions
(continued)
• Drugs containing FD&C Yellow No. 5
– Any drug, prescription or OTC, that contains FD&C
Yellow No. 5 (tartrazine) must specifically state so
• Used as a color additive
• Known to cause allergic-type reactions (including
bronchial asthma) in susceptible individuals.
• Warning must appear in “Precautions” section of
labeling

9. General Labeling Provisions
(continued)
• Drugs containing sulfites
– This chemical is used to prevent oxidation of the active
drug ingredient and maintain drug potency.
– It is also known to cause allergic-type reactions (including
bronchial asthma) in susceptible individuals.
• Prescription drugs containing sulfites:
– Statement must appear in “Warnings” section of labeling
• Epinephrine injection containing sulfites:
– Statement must appear in “Warnings” section of labeling
but should also include the following: “The presence of a
sulfite in this product should not deter administration of
the drug for treatment of serious allergic or other
emergency situations.”

10. General Labeling Provisions
(continued)
• Bar code label requirements
– Applies to all prescription drug products including
• Prescription drug samples
• Allergenic extracts
• Intrauterine contraceptive
• Medical gases
• Radiopharmaceuticals
• Low-density polyethylene
– Not required for prescription drugs sold directly to
patients, but applies if sold to or used in hospitals.

11. Labeling Requirements for
Prescription Drugs and/or
Insulin

12. Labeling Requirements for
Prescription Drugs and/or
Insulin
Labels for prescription drugs and/or insulin must include:
• Clear identification of drug
• Net quantity of contents
• Weight of contents
• Recommended or usual dosage
• Statement of ingredients

13. Labeling Requirements for
Prescription Drugs and/or
Insulin (continued)
• Specific information
– Description - Precautions
– Clinical pharmacology - Adverse reactions
– Indications and usage - Drug abuse & dependence
– Contraindications - Overdosage
– Warnings - Dosage and administration
– Pregnancy - Nursing mothers
– Pediatric use - Adverse reactions
– Drug interactions - Laboratory tests

14. Labeling Requirements for
OTC Drugs

15. Labeling Requirements for
OTC Drugs
Labels for over-the-counter drugs must include:
• Clear identification of drug in layman terms
• Net quantity of contents
• Weight of contents
• Pregnancy/breast-feeding warning
• Sodium content if 5 mg or more per dose
• Calcium content if 20 mg or more per dose
• Magnesium content if 8 mg or more per dose
• Potassium content if 5 mg or more per dose

16. Labeling Requirements for
OTC Drugs (continued)
• Specific information
– Drug facts - Directions
– Active ingredients - Purpose
– Inactive ingredients - Side effects
– Use - Overdosage
– Warnings - Contraindications
– Allergic reaction warnings - Pediatric use
– Pregnancy/breast feeding

17. Exemptions from Adequate
Directions for use

18. Exemptions from Adequate
Directions for use
A drug is exempt from labeling directions for use if drug is
• In possession of a retail, hospital, clinic pharmacy, or public
health agency lawfully engaged in dispensing prescription
drugs
• In possession of a licensed practitioner
• Label displays
– Statement “Rx only”
– Recommended or usual dosage
– Route of administration
– Quantity
– Identifying lot or control number

19. Labeling Claims for Drugs in
Drug Efficacy Study

20. Labeling Claims for Drugs in
Drug Efficacy Study
• The National Academy of Sciences – National Research
Council, Drug Efficacy Study Group completed an exhaustive
study reviewing the labeling claims made for drugs and
concludes them as
– “Effective”
– “Probably effective”
– “Possibly effective”
– “Ineffective”
– “Ineffective as a fixed combination “
– “Effective but”
• Drugs that have been evaluated must disclose the Academy’s
conclusions or they are considered misbranded and
misleading

21. Reference
Code of Federal Regulations (2006, April 1). 21CFR Part 201 Labeling.
Retrieved October 9, 2006 from
http://www.access.gpo.gov/nara/cfr/waisidx_06/21cfr201_06.html