Pregnancy and Lactation Labeling Final Rule
[12/3/14] The FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule).
The PLLR requires changes to the content and format for information presented in prescription drug labeling in the Physician Labeling Rule (PLR) format to assist health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication, thus allowing them to make informed and educated decisions for themselves and their children. The PLLR removes pregnancy letter categories – A, B, C, D and X. The PLLR also requires the label to be updated when information becomes outdated.
Below is a comparison of the current prescription drug labeling with the new PLLR labeling requirements.
The Pregnancy subsection (8.1) includes information for a pregnancy exposure registry for the drug when one is available. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women. Information about the existence of any pregnancy registries in drug labeling has been recommended but not required until now. Information in the Pregnancy sub-section includes a Risk Summary, Clinical considerations, and Data. Information formerly found in the “Labor and delivery” subsection is now included in the “Pregnancy” subsection.
The Nursing mothers subsection was renamed, the Lactation subsection (8.2), and provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.
The Females and Males of Reproductive Potential subsection (8.3), new to the labeling, includes information, when necessary, about the need for pregnancy testing, contraception recommendations, and information about infertility as it relates to the drug.
The labeling changes go into effect on June 30, 2015. Prescription drugs and biologic products submitted after June 30, 2015, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.
Labeling for over-the-counter (OTC) medicines will not change; OTC drug products are not affected by the final rule.
Concurrently with publishing the PLLR, FDA also issued draft guidance for industry to assist drug manufacturers in complying with the new labeling content and format requirements.
FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products Pregnant? Breastfeeding? Better Drug Information Is Coming
- FDA Voice Blog: Helping patients and health care professionals better understand the risks and benefits of medications for pregnant and breastfeeding women
- Questions and Answers on the Pregnancy and Lactation Labeling Rule
Outline of Section 8.1 – 8.3 on Drug Labeling
PLLR Final Rule and Labeling Requirements
Pregnancy and Lactation Labeling Rule Guidance for Industry and Staff: Pregnancy, Lactation, and Reproductive Potential--Labeling for Human Prescription Drug and Biological Products--Content and Format
Federal Register Notice
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format(PDF - 208KB)
How to Comment on the Draft Guidance for Industry
To comment on the draft guidance on the labeling content and format requirements:
- Read the draft guidance.
- Starting Thursday, December 4, 2014, go to Regulations.gov to submit comments.
Additional Guidance Documents
- Clinical Lactation Studies (draft, 2005) (PDF - 363KB)
- Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
- Establishing Pregnancy Exposure Registries (final, 8/2002) (PDF - 266KB)
- Evaluating the Risks of Drug Exposure in Human Pregnancies (final, 2005) (PDF - 3.1MB)
- Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities (draft, 10/2001) (PDF - 392KB)
- Pharmacokinetics During Pregnancy and Lactation (draft, 10/2004) (PDF - 324KB)