Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Guidance for Industry | Guideline Explorer

Description

The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for these repackaged products and appropriate expiration dates under those circumstances.

Scope & Applicability

Product Classes

3

Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

Subject of the guidance regarding expiration dating

Unit-Dose Repackaged Drug Products

Products repackaged into single-dose containers

Solid Oral Dosage Form

Example of risk assessment for manufacturing process

Stakeholders

2

Outsourcing facilities

Facilities compounding drug products pursuant to section 503B.

Commercial pharmaceutical repackaging firms

Entities required to register and comply with CGMP

Regulatory Context

Attributes

3

Moisture sensitivity

Property of the drug product to be assessed

Moisture permeability

Data required for Class B material

Expiration Date

Property of a device that may be changed via established protocols

Related CFR Sections (5)

21CFR211.160§ 211.160 General requirements.
(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted Read full regulation →
21CFR207.3§ 207.3 Bulk drug substance.
Bulk drug substance, as referenced in sections 503A(b)(1)(A) and 503B(a)(2) of the Federal Food, Drug, and Cosmetic Act, previously defined in § 207.3(a)(4) , means the same as “active pharmaceutical ingredient” as defined in § 207.1 .Read full regulation →
21CFR201.17§ 201.17 Drugs; location of expiration date.
When an expiration date of a drug is required, e.g., expiration dating of drug products required by § 211.137 of this chapter , it shall appear on the immediate container and also the outer package, if any, unless it is easily legible through such outer package. However, when single-dose containers Read full regulation →
21CFR211.166§ 211.166 Stability testing.
(a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include:Read full regulation →
21CFR211.137§ 211.137 Expiration dating.
(a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211.166 .Read full regulation →

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