A guidance issued by FDA on January 12 makes clear that the agency does not favor some long-standing habits of pharmacy personnel related to the repackaging of drug products. Take, for example, the beyond-use date BUD for tablets taken from a manufacturer's large container and repackaged into smaller containers. The BUD of 6 months agrees with the time frame for expiration dating stated by FDA in a decades-old compliance policy guide for unit dose repackaging firms, said Dennis Tribble, an expert in pharmacy operations automation who works for medical device maker BD. But referencing the date of the original container's first opening in determining the BUD is not what pharmacists usually do when repackaging tablets or capsules, he said. Tribble, expressing his own opinion and not that of his employer, said "FDA doesn't see any difference-or doesn't appear to see any difference-between perforation of a [sterile] vial for removing its contents and the opening of a bottle of pills. That regulatory view by FDA agrees with what the agency has said over time, he said. Jillanne M.
The nature of drug distribution within hospitals in particular has made such packaging useful and convenient in assuring proper administration of medication to patients. Questions have arisen, however, as to whether drugs thus repacked need expiration dates based on stability data on the drugs in the unit dose containers.
2. Consultant Pharmacist should check expiration dates during the physical inspection each month Pharmacy policies should address the role of the Consultant Pharmacist IV. Document Inspections 1. Both nursing and the Consultant Pharmacist should document and sign their inspection reports benjamingaleschreck.com Size: KB. FDA's guidance for industry, "Changes to an Approved NDA or ANDA" explains that the manufacturer of an approved drug product may extend the expiration date for the drug product based on their own. The expiration date does not exceed six months; and The six month expiration period does not exceed 25 per cent of the remaining time between the date of repackaging and expiration date shown on.
In light of these standards, under certain conditions the Food and Drug Administration would not ordinarily deem it necessary for health protection, nor for assurance of stability of the drug, to require that stability studies be done on the drug in the unit dose container. The Current Good Manufacturing Practice Regulations require that, with certain exceptions, drug products must bear expiration dates derived from tests conducted on samples stored in the same immediate container closure system in which the drug is marketed.
His membership on that subcommittee and the overarching Compounding Expert Committee ended in FDA defines in-use time for a compounded sterile liquid drug product as the maximum allowable interval from penetration of the container or closure system to the start of administration to the patient.
The January 12 repackaging guidance advises pharmacies to take into account the in-use time stated in an FDA-approved drug product's labeling when assigning a BUD to a repackaged sterile drug product. If the labeling does not specify an in-use time or if the sterile drug product being repackaged is an unapproved product on FDA's drug shortages list, the guidance advises pharmacies to assign a BUD according to the standards in the proposed revision of USP chapter or the expiration date on the original container, whichever results in the shortest time frame.
Potassium chloride injection has been on FDA's drug shortages list for nearly 5 years. Neither manufacturers' labeling states an in-use time per se; rather, users are instructed to discard the original container no more than 4 hours after first penetrating its closure.
Expiration Date. This issue's tip involves expiration dating. Sometimes a package of medications will have an expiration date noted as 09/ The question raised is, "Does this expire 9/1/19 or 9/30/19?"When only the month and year are noted on a medication expiration date, it means the medication expires on the last day of that month. Apr 01, The information on this page is current as of April 1 For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. Expiration dating. ate your expiration date using the date functionality in the app. When the new expiration date is indicated, select Done. Select ate (located at the bottom of the page). If you are unable to ate your license expiration date, please contact [email protected]
The proposed revision of USP chapter -the apparent next source of information on assignment of the BUD in this case-says the in-use time for a pharmacy bulk package is "[a]s specified by the manufacturer" if opened, stored, and used for sterile compounding in an environment with International Organization for Standardization class 5 or better air quality.
Among FDA's other expectations of pharmacies is that they repackage drug products in accordance with the handling and storage instructions in FDA-approved labeling. Propofol injectable emulsion, the guidance explains in a footnote, has labeling stating that the drug "undergoes oxidative degradation in the presence of oxygen and is therefore packaged under nitrogen.
Dec 11, Expiration date: The date for a drug estimated for its shelf life with proper storage in sealed containers away from harmful and variable factors like heat and humidity. transported and is calculated from the date or time of compounding. Expiration date is a manufacturer defined term based on very specific testing used for commercially available products. A CSP cannot be labeled with the term "expiration date" or any variance thereof. It. Mar 10, The expiration date on the large container. The BUD of 6 months agrees with the time frame for expiration dating stated by FDA in a decades-old compliance policy guide for unit dose repackaging firms, said Dennis Tribble, an expert in pharmacy operations automation who works for medical device maker BD.
Thus, a pharmacy that repackages propofol and exposes it to oxygen during the process is producing a drug product that conflicts with FDA-approved labeling, the guidance states. In addition, when a drug degrades it may yield toxic compounds that could cause consumers to experience unintended side effects.
Patients with serious and life-threatening diseases may be particularly vulnerable to potential risks from drugs that have not been stored properly. There are a number of simple steps consumers can take to dispose of expired medications.
FDA supports a public health program involving other partners to extend the expiration dates for a limited number of carefully selected drug products. Federal stockpiles are stores of certain drugs that might be needed to prevent or treat diseases or conditions which may occur during a public health emergency.
SLEP is a fee-for-service program through which the labeled shelf life of certain federally stockpiled products can be extended after select products undergo periodic stability testing conducted by FDA.
Expiration Dating by Dana Gunders of the NRDC
Drugs held by consumers may have been stored under varied conditions after entering the market.