Description
The recommendations in this guidance apply broadly to the development of drug and biologic products. Accordingly, this guidance is intended for sponsors of investigational new drug applications (INDs); applicants of new drug applications (NDAs), biologics licensing applications (BLAs), abbreviated new drug applications (ANDAs); and manufacturers of prescription drugs marketed without an approved application or over-the-counter (OTC) monograph drugs. This guidance provides a set of principles for using a systems approach to minimize medication errors relating to product design and container closure design and thus enhance patient safety.
Scope & Applicability
Product Classes
8Products in solution or dry powder requiring dilution.
Small-volume and large-volume injectable products whose labeling advises against admixing
Products that should have distinct strengths from immediate-release versions.
Over-the-counter drugs subject to section 505G; manufacturers of over-the-counter monograph drugs should follow recommendations; drugs not approved under section 505 or 351
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Over-the-counter drugs stable for at least 3 years may be exempt from labeling requirements.
Subject of the minor changes guidance
Assessment of Adhesion for Topical and Transdermal Systems
Stakeholders
8responsible for justifying omission of studies
patient, caregiver, physician, nurse, pharmacist involved in medication use
Assist sponsors in the nonclinical evaluation
entity submitting marketing applications
Published report on health care regulation reform
Entity responsible for submitting NDINs
Way questions are framed is critical to collecting unbiased patient input
Allowed value for reporter qualification
Regulatory Context
Attributes
5Required information for RLD/RS and proposed products.; Product characteristic in ANDA background
Changes to an already marketed drug product throughout its lifecycle.
Requirements for special packaging to confer child resistance
Physical marks on tablets to facilitate splitting.
Critical for identifying the product when separated from packaging.
Identified Hazards
Hazards
6Safety concern addressed by PDUFA IV goals
Risk prevented by administration of opioid blockers
Risk posed to young children by palatable ODTs and films
Risk if a restricted delivery system is easily removed or pushed into the bottle.
Risk of inappropriate administration of extra doses
Potential sound-alike and look-alike confusion with drug names
Related CFR Sections (3)
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
- 21CFR4.2§ 4.2 How does FDA define key terms and phrases in this subpart?
The terms listed in this section have the following meanings for purposes of this subpart:Read full regulation →
- 21CFR206.10§ 206.10 Code imprint required.
(a) Unless exempted under § 206.7 , no drug product in solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless it is clearly marked or imprinted with a code imprint that, in conjunction with the product's size, shape, and color, permits the unique identRead full regulation →
See Also (8)
- Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry (Status: Draft)
- Application of Human Factors Engineering Principles for Combination Products: Questions and Answers: Guidance for Industry and FDA Staff (Status: Final)
- Regulatory Considerations for Prescription Drug Use-Related Software (Status: Draft)
- Platform Technology Designation Program for Drug Development (Status: Draft)
- Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products (Status: Draft)
- Application User Fees for Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry and Other Interested Parties (Status: Draft)
- Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry (Status: Draft)