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. A guidance specific to biological products, such as therapeutic monoclonal antibodies, is in the works. A draft guidance on the compounding and repackaging of radiopharmaceuticals by state-licensed nuclear pharmacies was released in December.
FDA Extends Expiration Date for Certain Lots of EpiPen
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. The FDA has good and bad news.
account the manufacturer’s Beyond Use Date (BUD) and the effect on stability indication may contact FDA to open an Investigational New Drug Application.
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 FDA also issued a separate revised draft guidance document on repackaging of biological products, which will be the subject of a separate blog post. The Agency states, for example, that if tablets are removed from a blister pack and placed in a different container, then that would be considered repackaging.
However, if the blister packs are placed into a different container for later use leaving the blister packs intact then that would not be repackaging. Repackaging may alter the characteristics of drug products in ways that FDA did not consider during the drug approval process, affecting stability, safety and efficacy. Some highlights of the guidance include:. Palmer —. The drug must be repackaged by a state-licensed pharmacy, federal facility or outsourcing facility, and under the direct supervision of a pharmacist.
If repackaged by a pharmacy or federal facility but not an outsourcing facility , the drug must be pursuant to a prescription or order for an individually identified patient. Except for single-dose vials, the drug must be repackaged in a way that does not conflict with approved labeling.
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?
Provides for the use of containers meeting USP Class B standards if certain conditions are met.” Background. FDA current good manufacturing.
Please contact customerservices lexology. This update will provide our usual summary of recent actions as well as highlight some trends observed from the regulatory agencies over the past month. The DEA continues to allow flexibility regarding controlled substances to ensure providers have the necessary medications available to treat patients. For the duration of the public health emergency, the DEA is allowing DEA-registered hospitals and clinics to handle controlled substances at satellite hospitals and clinics that are nonregistered locations.
Additionally, the DEA is allowing distributors to ship controlled substances directly to these satellite hospitals and clinics, even though they are nonregistered locations. Products that have been subject to FDA warning letters include CBD products , homeopathic drug products , antiviral drug products , essential oils , beverage concentrates , hemp products and an industrial bleach promoted by a church.
Compounding FAQ for veterinarians
The site navigation utilizes arrow, enter, escape, and space bar key commands. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items. The regulatory function is vital in making safe and effective healthcare products available worldwide.
FDA study gets to the heart of expired medicine and safety were perfectly good to use even 15 years after the expiration date. So, the.
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.
But the law created some confusion, particularly for hospital pharmacies in health systems that compound and repackage sterile drugs and that compound biologics for shipment to outlying affiliated pharmacies. These two guidance documents, taken together, attempt to fill that regulatory gap. It should be noted that guidance documents are only advisory—they do not have the power of legal statute. However, the FDA uses them as a guide to enforcing the laws under its authority.
The point of both documents is to give three categories of pharmacies clear direction on when their repackaging practices will be legal, and therefore not subject to FDA enforcement.
Beyond-Use and Expiration Date Differences
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.
Examples of compounding include:.
The “beyond use” date would never be later than the expiration date on (SLEP) undertaken by the FDA for the Department of Defense.2,7,
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. Stockpiling drugs, vaccines, and medical products is critical to ensure public health emergency preparedness for both the U.
To avoid the need to replace entire stockpiles every few years at significant expense, and because it was recognized through testing that certain products remained stable beyond their labeled expiration dates when properly stored, the Shelf-Life Extension Program SLEP was established in SLEP is the federal, fee-for-service program through which the labeled shelf life of certain federally stockpiled medical materiel e. The program is administered by the U.
Drug Expiration Dates — Do They Mean Anything?
A: USP considers adding flavoring to a conventionally manufactured product to fall within the scope of compounding, because there are known instances when flavoring components have destabilized a product. If a flavoring component is added to a manufactured product that does not contain a preservative e. If a flavoring component is added to a manufactured product that contains a preservative e.
The addition of flavoring including the flavor manufacturer or product, lot number, and expiration date must be documented in the patient record notes for the prescription. A: Domperidone compounding is permissible only as part of an investigational new drug application IND.
Administrative Order · Executive Order · FDA Circular · Memorandum Circular · Others “Requirement for the Labeling of Pharmaceutical Products”, as the date after which or after which il is not permissible to sell, distribute or use said product. the sale or offering for sale of any drug or device beyond ils expiration date.
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,. 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 Most users should sign in with their email address.
If you originally registered with a username please use that to sign in. To purchase short term access, please sign in to your Oxford Academic account above. Don’t already have an Oxford Academic account? Oxford University Press is a department of the University of Oxford. It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account. Sign In. Advanced Search.
FDA-Registered 503B Outsourcing Facility
The big question is, do pills expire? With a splitting headache, you reach into your medicine cabinet for some aspirin only to find the stamped expiration date on the medicine bottle is more than a year out of date. So, does medicine expire?
Differentiation between “expiration date” and “beyond use date” FDA good manufacturing standards require that repackaged medications have a MAXIMUM.
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.
FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms
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.
Further, because official validated testing methods e. Association of Official Analytical Chemists [AOAC International] , for dietary supplements are evolving, especially for botanical dietary ingredients, such methods are not always available to assess the strength of a dietary ingredient in a dietary supplement.
Beyond-Use Date (BUD) (see General Notices Storage and Beyond-Use Dating multiple-dose container with antimicrobial pre- and efficacy by the FDA.
PDF version. Are dates required on these food products? Does it mean the product will be unsafe to use after that date? Here is some background information answering these and other questions about product dating. What is Food Product Dating? Two types of product dating may be shown on a product label. The calendar date provides consumers with information on the estimated period of time for which the product will be of best quality and to help the store determine how long to display the product for sale.
Except for infant formula, product dating is not required by Federal regulations. For meat, poultry, and egg products under the jurisdiction of the Food Safety and Inspection Service FSIS , dates may be voluntarily applied provided they are labeled in a manner that is truthful and not misleading and in compliance with FSIS regulations 2. To comply, a calendar date must express both the month and day of the month.
In the case of shelf-stable and frozen products, the year must also be displayed. Additionally, immediately adjacent to the date must be a phrase explaining the meaning of that date such as “Best if Used By.
FDA Outlines Conditions for Pharmacies to Repackage Drug Products
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.
Take, for example, the beyond-use date (BUD) for tablets taken from a manufacturer’s large container and repackaged into smaller containers.
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.