Expiration dating of repackaged medications
These ICH and FDA recommendations provide reasonable assurance that a drug product will maintain its physical and chemical characteristics and potency during the approved shelf life as long as it is retained in the original container closure system and stored under the same conditions defined in the product labeling.
Since most drug products are repackaged at the time of dispensing by a pharmacist, unless they are readily available in unit-of-use form from the manufacturer, it is imperative to consider the stability of these products once they are opened and repackaged in a different container closure system.
Sections 211.137(a) and 211.137(b) require that each drug product has an expiration date established by appropriate stability testing, and such expiration dating must be associated with the storage conditions stated on the product labeling and determined by stability studies described in section 211.166. The storage conditions and expiration dating for a drug product are established on the basis of stability data generated under conditions of accelerated, intermediate (where applicable), and long-term degradation in the proposed market “container closure system” (defined by FDA as “the sum of packaging components that together contain and protect the dosage form”) or in simulated proposed packaging for storage, shipping, and distribution of bulk product.
To comply with current regulations, the sponsors of drug product applications are required to provide supportive quality, safety, and efficacy data to meet the established standards prior to introducing a product into the U. The Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), in guidance document Q1A(R2), “Stability Testing of New Drug Substances and Products,” recommends that pharmaceutical manufacturers should conduct stability studies on the drug product that has the same formulation and is packaged in the same container closure system as proposed for marketing.
Also, the pharmacist is required to affix a beyond-use date (commonly known as a pharmacy expiration date) on the repackaged container prior to dispensing the drug to a patient.
The Federal Food, Drug, and Cosmetic Act and its subsequent amendments provide the authority and responsibility to the Food and Drug Administration (FDA) to ensure that all drug products approved for U. marketing meet standards of quality, safety, and efficacy.It also pairs seamlessly with the Rx TOOLKIT Label Solutions Library to provide easy to find, consistent, and professionally designed label templates.Combining these solutions increases compliance, uniformity, and efficiency while lowering the potential for error.Logbooks and State Law Whenever a product or compounded product is packaged for distribution, best practices (and some state laws) require that all information, including for source ingredients, must be documented including: expiration date(s) for final product and source ingredient(s), number, lot number, and preparer’s initials.Typically this information is stored in large binders, making it difficult to store and reference.