FDA Outlines Conditions for Pharmacies to Repackage Drug Products

FDA Outlines Conditions for Pharmacies to Repackage Drug Products

Pharmacopeia, 3 as justification for the BUD requirements. The DQSA had two sections. One was a response to the deaths caused by contaminated compounded drugs produced by the New England Compounding Center NECC , and to questions about compounded medications in general. It set up a new drug-compounding regulatory program focused on large-scale compounders, referred to as outsourcing facilities. They are allowed to voluntarily enter the new B program, which the FDA oversees. The law also made some changes to the existing A program, which allows states to inspect retail and hospital pharmacies.

Beyond-Use and Expiration Date Differences

This is a good question and deserves an answer. Homeopathic remedies are also exempt from expiration dating see 21 CFR Section However, we were uncertain whether there are current and generally available methods to determine the expiration dating of other dietary ingredients. We did not propose to require expiration dating because we had insufficient scientific information to determine the biological activity of certain dietary ingredients used in dietary supplements, and such information would be necessary to determine an expiration date.

Beyond-Use Date (BUD) (see General Notices Storage and Beyond-Use Dating multiple-dose container with antimicrobial pre- and efficacy by the FDA.

Compounding under USP is much broader and includes many more situations than are subject to the FDA definition of compounding. The FDA states that “Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling” [21 USC k and m ].

The final revised version of USP fails to explicitly define the terms compounding and dispensing. However, USP does discuss the above-mentioned FDA statement about compounding, which clearly indicates that mixing or reconstituting performed in accordance with the instructions as stated in the package insert are not considered as compounding by the FDA.

Nevertheless, the USP Expert Committee on Sterile Compounding—the committee that was responsible for the development of USP —believed that even the mixing and reconstituting processes that are carried out per the package insert’s directions will be subject to the requirements of USP for the following reasons:. Nevertheless, the USP Expert Committee on Sterile Compounding—the committee that was responsible for the development of USP —believed that even the mixing and reconstituting processes that are carried out per the package insert’s directions will be subject to the requirements of USP for the following reasons: The FDA-approved labeling product package insert rarely describes environmental quality e.

When such durations are specified, they may refer to chemical stability and not necessarily to microbiological purity or safety.

Pharmaceutical Advisories

The Food and Drug Administration just pointed out something about bottles of hand sanitizer people are hoarding during the coronavirus pandemic: They have an expiration date. It’s likely few notice the fine print while grabbing handfuls off shelves in recent weeks. It’s hard enough just to find a bottle lately.

FDA does not require food firms to place “expired by”, “use by” or “best before” dates on food products. This information is entirely at the discretion of the.

The U. The FDA states that this action was taken in response to ” 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 “. In addition, once final, it will supersede Compliance Policy Guide Comments regarding the draft document should be submitted within 60 days of publication.

In the previous draft guidance on expiration dating issued in May , the FDA had proposed to set the expiration date for nonsterile, unit-dose repackaged drugs to one year, which was also aligned with USP standards at the time for beyond use dating for unit-dose repackaging by dispensers. FDA will not enforce certain stability study requirements for repackaged drug products in the following cases:.

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Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance

Q: What is compounding? A: Simply put, compounding is any manipulation of a drug beyond that stipulated on the drug label. Veterinary drugs should only be compounded based on a licensed veterinarian’s prescription, and to meet the medical needs of a specific patient. Manipulation might include mixing, diluting, concentrating, flavoring, or changing a drug’s dosage form. Some states allow veterinarians to prescribe compounds for administration to patients in the practice; but depending on state rules, it is typically not legal to dispense medications previously compounded by a pharmacy to leave the veterinary practice with clients, so state rules should be reviewed and followed.

Take, for example, the beyond-use date (BUD) for tablets taken from a manufacturer’s large container and repackaged into smaller containers.

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. Schulte, ASHP’s director for federal regulatory affairs, said FDA views the activity of repackaging a drug product as a manipulation that presents a risk and fits into the “larger discussions” about the quality of drug compounding.

Expiration date

Orange Book Archives. FDA is still considering applicability of these policies to hospitals and healthcare systems, which it intends to address in yet another guidance document. FDA also issued a separate revised draft guidance document on repackaging of biological products, which will be the subject of a separate blog post.

But the BUD the FDA is trying to sell—the “beyond use date” of repackaged pharmaceuticals or biologics—isn’t going down easy with hospital pharmacists.

A beyond-use date is a date placed on a prescription by a pharmacy for compounded medications they prepare, noting when that prescription should no longer be used. This date is determined by the pharmacy when they prepare a compound prescription based on different factors, including:. The beyond-use date is different than an expiration date of a drug.

This includes moving a medication to a different container, which is the normal practice for pharmacies dispensing prescriptions. Based on the type of drug, how fast it degrades, dosage, type of container, storage conditions, prescription length, the likelihood of contamination. Based on testing a drug in specific conditions related to storage containers, lighting, temperature, etc. The FDA says it’s dangerous to take medications after their expiration date because they may not be as effective, their chemical composition may have changed, or they may have deteriorated to a point where harmful bacteria could breed.

Particularly with antibiotics, it’s important to watch the expiration date because using an expired antibiotic means it may not be potent enough to completely treat your infection, leaving you at risk for a worse one. The bottom line is that it is best to not use expired medications because there is no guarantee that they will work the way they are supposed to and they may even make you worse.

FDA-Registered 503B Outsourcing Facility

PDF version. Are dates required on these food products? Does it mean the product will be unsafe to use after that date?

To extend a compounded preparation’s BUD would require a validated stability-​indicating method and subsequent stability testing. ‘s issued by the FDA.

To help prepare for public health emergencies, medical countermeasures MCMs may be stockpiled by governments and even by some private sector partners. For example, the U. Some state and local governments and private sector entities also stockpile MCMs to have ready access to them if an emergency were to occur. A medical product is typically labeled by the manufacturer with an expiration date.

This reflects the time period during which the product is expected to remain stable, or retain its identity, strength, quality, and purity, when it is properly stored according to its labeled storage conditions. Expiration dating can present challenges to MCM stockpilers because MCMs that have reached their labeled expiration date in most cases cannot be used.

While this is important to ensure patient safety, it also means that the MCMs, some of which might still be stable, must be replaced regularly, which can be very costly. In some cases, testing has shown that certain properly stored medical products can be used beyond their labeled expiration date if they retain their stability. The manufacturer of an approved drug product may extend the expiration date for the drug product based on acceptable data from full, long-term stability studies on at least three pilot or production batches in accordance with a protocol approved in the NDA or ANDA.

FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms

Cheryl A. 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. According to the guidance, FDA wants the BUD for those repackaged tablets to be the earliest of 6 months from the first time the large container is opened,.

Differentiation between “expiration date” and “beyond use date” FDA good manufacturing standards require that repackaged medications have a MAXIMUM​.

Last updated on Jul 22, For many patients, these questions arise because medications can be expensive and it is costly to frequently replace expired — but unused — medications. But is it safe to use medicines past their expiration date? The expiration date is the final day that the manufacturer guarantees the full potency and safety of a medication.

Drug expiration dates exist on most medication labels, including prescription, over-the-counter OTC and dietary herbal supplements. For legal and liability reasons, manufacturers will not make recommendations about the stability of drugs past the original expiration date. Once the container of medication is opened after production, that expiration date is no longer guaranteed. The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration FDA.

Drug products marketed in the US typically have an expiration date that extends from 12 to 60 months from the time of manufacturer. Once the original container is opened, either by the patient or the health care provider who will dispense the drug, that original expiration date on the container can no longer be relied upon. At the pharmacy, “beyond-use” dates are often put on the prescription bottle label given to the patient.

These dates often say “do not use after These dates are typically one year from the date of fill. But why would these expiration dates be different?

Two Draft FDA Guidance Documents Stir Controversy

Do you have stability studies to justify your expiration dating beyond-use date on repackaged drugs? Do you know what class of packaging materials you use? Do you have a separate quality team overseeing your packaging operation? Proposed changes in pharmacy packaging requirements could have a significant impact on your operations and budget. Shorter dating and more regulations could mean more time spent on packaging, more waste due to shorter dating, more personnel needed for packaging and higher costs.

Lower your risk.

Beyond-use exposure and storage dates or times (see “Determining Beyond-Use Dates” in USP)*for sterile products that have been either opened or prepared.

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FDA Expiration Date BVRMC Pharmacy


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