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There has been some controversy over applying the United States Pharmacopeia USP shelf life rules for compounded pharmaceutical products to allergen extract mixes. These rules require that all compounded mixed materials be disposed of every 28 days due to sterility concerns. The allergy industry has successfully challenged this requirement and made the case that allergen extract mixes are an exception to this rule. Besides following routine sterile handling aseptic procedures, compounding mixing personnel are also required to pass a Media Fill Test at least annually. This is a test of aseptic technique. A written test is also recommended. ALK does not sell nor specifically endorse any Media Fill Test product on the market but can make suggestions upon request. The written test, as well as the guidelines for handling allergenic extracts, are available from www. An abbreviated list of guidelines is also printed in the most recent update of the Allergen Immunotherapy Practice Parameters If you encounter any issues with the USP shelf life guidelines for compounded products, please contact your allergen extract supplier for assistance.

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FDA, set out to investigate the efficacy of pharmaceutical drug stockpiles beyond their expiration dates. The results showed that about 90 percent of the drugs were still effective far past their expiration dates. Fifteen years ago, the U.

Chemical solutions used for argentometric procedures, such as M silver nitrate, showed an expiration dating of 7 months. Nevertheless, for lower concentrations ( M) the stability decreased to 5 months, due probably to the much higher incidence of photochemical degradation.

SVP Batch compounding will assure your pharmacy the lowest possible cost for the safest, best quality CSPs, available whenever they are needed. Recent concern about the quality of CSPs acquired from commercial compounding facilities by the hospital and clinical pharmacy has led to an increased interest in performing batch compounding in-house. Until now, such sterility testing of compounded batches has been very inconvenient, complex, and cost-prohibitive. This is done to minimize the potential for clinically-significant contamination by limiting the time for any organisms which might be present to multiply.

It is imperative that pharmacies that engage in lower-cost batch compounding have a complete understanding of all the procedures required to extend dating safely and effectively. Simply running the correct number of sterility tests for a batch of preparations does not in any way assure the sterility of that batch unless all the procedures discussed below are rigidly followed. Batch Sterility Testing For the purposes of sterility testing, a batch is not simply “a group of containers of the same solution compounded at the same time.

There can be no variation in the factors that present a possibility of microbial contamination, or the compounding process will encompass too many uncontrolled variables, and the results of testing will not be adequately representative of batch quality. For hand-compounded preparations, special efforts are required and quality assurance procedures must be adhered to if sterility testing is to be relied upon as the basis for extending dating.

Current Developments

Availability and Validity True 7. As per Section 5. This service is not available for the release of back-ordered products or lot changeovers. To receive a monthly list of lot changeovers, please subscribe to our free monthly Email Notice. USP strives to plan ahead to replace depleted lots in a timely manner. However, despite our best efforts, some USP Reference Standards might occasionally be out of stock temporarily.

EXPIRATION DATING PREPACKAGE versus REPACKAGE “Prepackaged drug product” means a drug that originally was in finished packaged form sealed.

Liquid sterilant, vapor phase sterilant 0. Certain liquid chemical sterilizers intended for use on critical or semicritical medical devices are defined and regulated by the U. Use of antiseptics to disinfect hands has been shown to be more effective than soap and water in reducing the counts of bacteria on the skin; repeated antiseptic use further reduces these counts. These principles may be applied to clean-room operators in the pharmaceutical industry.

In practice, the plots show a more sigmoid curve with a slower initial reduction in numbers followed by an increasing rate with respect to time. The rate constant, K, for the disinfection process can be calculated by the formula: As with a first-order chemical reaction, the same concentration of disinfectant reduces the number of organisms more rapidly at elevated temperatures. This can be expressed as a temperature, T, coefficient per 10 rise in temperature, Q10, calculated by the formula: Further evidence that a first-order reaction is an inadequate description of disinfection is that the Q10 values for chemical and enzyme reactions are 2 to 3, while the common disinfectants phenol and alcohol have a Q10 of 4 and 45, respectively.

Critical to the successful employment of disinfectants is an understanding of the effect of disinfectant concentration on microbial reduction. A plot of the log of the time to reduce the microbial population in a standard inoculum to zero against the log of the disinfectant concentration is a straight line with the slope of the line termed the concentration exponent, n. The relationship can be expressed as follows: The wide differences in concentration exponents, n, have practical consequences in picking the use dilution of different disinfectants and in using dilution to neutralize a disinfectant in disinfectant-effectiveness testing and routine microbial monitoring of the manufacturing environment.

For example, mercuric chloride has a concentration exponent of 1, so a 3-fold dilution will reduce the disinfectant activity by 31 or by one-third , while phenol with a concentration exponent of 6 will have a 36 or a fold reduction in disinfectant activity.

Édition 2018

Classification of air cleanliness. For example, particles of 0. Barrier isolators provide a suitable environment by restricting any ambient air from the work chamber. These systems are not as sensitive to external environments as the HEPA-filtered unidirectional airflow units.

of the United States Pharmacopeia (USP) chapter for compounding sterile prep-arations are presented. Summary. dating) assigned. Expiration dates are assigned by the manufacturer to medications to show the time frame that the medication is expected to meet USP monograph standards.

It is intended to provide public portions of communications within the General Committee of Revision and public notice of proposed new and revised standards of the USP and NF and to afford opportunity for comment thereon. The organization of PF includes, but is not limited to, the following sections. Supplements Supplements to official text are published periodically and include text previously published in PF, which is ready to be made official.

Reagent Standards The proper conduct of the Pharmacopeial tests and assays and the reliability of the results depend, in part, upon the quality of the reagents used in the performance of the procedures. Unless otherwise specified, reagents are to be used that conform to the specifications set forth in the current edition of Reagent Chemicals published by the American Chemical Society. Where such ACS reagent specifications are not available or where for various reasons the required purity differs, compendial specifications for reagents of acceptable quality are provided see Reagents, Indicators, and Solutions.

These are supplied by USP when they might not be generally commercially available or because they are necessary for the testing and are available only to the originator of the tests or assay. Where a test or an assay calls for the use of a compendial article rather than for a USP Reference Standard as a material standard of reference, a substance meeting all of the compendial monograph requirements for that article is to be used.

Units of Potency For substances that cannot be completely characterized by chemical and physical means, it may be necessary to express quantities of activity in biological units of potency, each defined by an authoritative, designated reference standard.

Determination of the expiration date of chemical solutions

While the CDC recommends that administration sets are not changed more frequently than every 72 hours, the USP recommends a maximum beyond use date of 48 hours. Neither organization provides specific guidance on expiration dating once the intravenous drug is dispensed. Likewise, neither addresses the length of time that a bag containing medication for continuous infusion may hang once administration to the patient has begun.

ScienTek Software, Inc. Mean Kinetic Temperature – A Short History By Mike W.H. Yang, Ph.D., Director of Software Development, ScienTek Software, Inc. The United States Pharmacopeia (USP) de nes Mean Kinetic Temperature (MKT) as the \single calculated An expiration dating period is usually understood to have been determined under this.

Fifteen years ago, the U. The testing, conducted by the U. Food and Drug Administration, ultimately covered more than drugs, prescription and over-the-counter. In light of these results, a former director of the testing program, Francis Flaherty, says he has concluded that expiration dates put on by manufacturers typically have no bearing on whether a drug is usable for longer.

Flaherty notes that a drug maker is required to prove only that a drug is still good on whatever expiration date the company chooses to set. The expiration date doesn’t mean, or even suggest, that the drug will stop being effective after that, nor that it will become harmful. Flaherty, a pharmacist at the FDA until his retirement last year.

Still, Joel Davis, a former FDA expiration-date compliance chief, says that with a handful of exceptions — notably nitroglycerin, insulin and some liquid antibiotics — most drugs are probably as durable as those the agency has tested for the military. And they acknowledge that expiration dates have a commercial dimension. But they say relatively short shelf lives make sense from a public-safety standpoint, as well.

New, more-beneficial drugs can be brought on the market more easily if the old ones are discarded within a couple of years, they say.

Shelf Life vs. Expiration Date of a Chemical Standard

Relates to State Board of Pharmacy, relates to sterile compounding, relates to permits. The bill contains the following provisions. The bill provides a definition for “compounding pharmacy” and describes sterile compounding pharmacies and non sterile compounding pharmacies. Beginning with appointments made on or after January 1, , the bill adds a physician and an advanced practice registered nurse to the Maine Board of Pharmacy, decreases the number of pharmacist members from 5 to 3.

MN H Pharmacy Regulation Pending – Carryover Changes licensing requirements for pharmacies, drug manufacturers, and wholesale drug distributors, requires all licensed pharmacies to comply with federal laws and state laws and rules related to operation of a pharmacy, requires out-of-state pharmacies dispensing drugs to residents of Minnesota to comply with federal laws related to operation of a pharmacy. MN H Health Pending – Carryover Relates to health, changes licensing requirements for businesses regulated by the Board of Pharmacy, clarifies requirements for compounding, makes changes to the prescription monitoring program.

At the time the CPG was adopted, this recommendation was substantially comparable to the USP standards on expiration dating of nonsterile unit-dose repackaged drug products. In , the USP revised its standards on the beyond-use dating of nonsterile solid and liquid dosage forms that are packaged in single- unit and unit-dose containers.

It is an epinephrine auto-injector with innovative features such as voice instructions that help guide a user with step-by-step instructions through the epinephrine delivery process and an automatic retractable needle system, a first for epinephrine auto-injectors, that injects the epinephrine and retracts the needle back into the device within seconds.

This new program removes potential and previously experienced insurance barriers, restrictions and delays, even for those commercially-insured patients with high-deductible plans. They know what it is like to live in fear of that life-or-death moment, both as patients and parents of food-allergic children. Their goal was to develop an epinephrine auto-injector that contained innovative features, such as a voice instruction system that helps guide patients and caregivers step-by-step through the injection process.

Eric and Evan Edwards believe and trust in AUVI-Q, not only for themselves, but also for their children and other families who may have to depend on it to administer epinephrine during an allergic emergency. AUVI-Q contains epinephrine, a well-established, first-line treatment for severe, life-threatening allergic reactions that occur as a result of exposure to allergens including food such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings or bites; latex and medication, among other allergens and causes.

Drug Expiration Dates – Are Expired Drugs Still Safe to Take?

Medically reviewed on Jun 11, by L. Anderson, PharmD Patients often have questions about drug expiration dates: Can I safely take a medication if it has reached the drug expiration date?

Therefore, the United States Pharmacopeia (USP), the body that sets the standards for pharmaceutical quality in the U.S., recommends using “beyond use” dates. The “beyond use” date would never be later than the expiration date on the manufacturer’s.

Thus, the successful manufacture of a pharmaceutical product requires the use of well-defined excipients and manufacturing processes that consistently yield a quality product. Excipients used in drug products typically are manufactured and supplied in compliance with compendial standards. However, the effects of excipient properties on the critical quality attributes CQAs of a drug product are unique for each formulation and process and may depend on properties of excipients that are not evaluated in USP or NF monographs.

The effects of variations in excipient material attributes depend on the role of an excipient in a formulation and the CQAs of the drug product. It covers the quality management system and the extent of good manufacturing practices GMP necessary throughout manufacturing for both batch and continuous processes. In light of the increasing globalization of the pharmaceutical industry and the harmonization of pharmaceutical registration requirements, deference to all schemes is becoming more essential.

Therefore, relevant portions of the manufacturing concepts are employed throughout this chapter. False Chapter Good Distribution Practices for Bulk Pharmaceutical Excipients The pharmaceutical excipient supply chain participants include manufacturers, distributors, brokers, suppliers, traders, transporters, forwarding agents, and repackagers.

The quality of pharmaceutical excipients is affected by inadequate control of activities including distribution, packaging, repackaging, labeling, and storage.

Expiration Dating and Stability Testing for Human Drug Products

Technical Service product or service. Technical Service must be made by means of an approved credit card or check and received in full prior to the commencement of service. Ownership of Bundle Packs The expiration on any TSS Bundle Pack purchase option is based on a one 1 year time line from purchase date as it relates to access to the online formula database. All other components customized formulas and compounding inquiries expire based on the limits of the individual components or one 1 year from purchase date, whichever comes first.

Compounding Inquiries, as identified in a Bundle Pack, are subject to limits on time.

AUVI-Q will be available by prescription nationwide on February 14, KALÉO ANNOUNCES U.S. AVAILABILITY AND PRICING TO PATIENTS OF AUVI-Q ® (Epinephrine Injection, USP) AUTO-INJECTOR, FOR LIFE-THREATENING ALLERGIC REACTIONS. AUVI-Q will be available by prescription nationwide on February 14,

Do you know how your epinephrine auto-injector is made? During an allergic emergency, you and your family count on your epinephrine auto-injector. That is why we are committed to quality. Over automated quality checks, using specially calibrated sensors and vision inspection systems, help ensure a consistent, high-quality product. Important Safety Information AUVI-Q is for immediate self or caregiver administration and does not take the place of emergency medical care.

AUVI-Q should only be injected into your outer thigh, through clothing if necessary. If you inject a young child or infant with AUVI-Q, hold their leg firmly in place before and during the injection to prevent injuries. Do not inject AUVI-Q into any other part of your body, such as into veins, buttocks, fingers, toes, hands, or feet.

If this occurs, seek immediate medical treatment and make sure to inform the healthcare provider of the location of the accidental injection. Only a healthcare provider should give additional doses of epinephrine if more than two doses are necessary for a single allergic emergency. Rarely, patients who use AUVI-Q may develop infections at the injection site within a few days of an injection.

Expiry Dating for Reagents and Solutions in Laboratories: What are FDA’s Expectations?

To date, Form FDA has been submitted in lieu of these forms. Jeffrey Shuren, Assistant Commissioner for Policy. We are proposing to revise CPG b.

USP’s Reference Standards are considered primary standards, except for certain biological USP Reference Standards with units of activity that are established against and traceable to the World Health Organization International Standards.

Each drug product may be a unique article because of, for instance, differences in 1 chemical and physical properties of the active ingredients or the excipients, 2 manufacturing procedures, 4 containers and closures, 5 proposed storage conditions, and 6 the stability of the article to maintain its quality or purity through the use of antioxidants or preservatives. Because of the uniqueness of each drug product, it is virtually impossible to provide one set of rules that can apply to all situations.

The CGMPs were purposely written broadly to allow for such unique differences. Absence of an Expiration Date The absence of an expiration date on any drug product packaged after September 29, , except for those drugs specifically exempt by Exemptions OTC drug products meeting the exemption of Information obtained from old stock, not previously the subject of stability studies, may also be utilized.

Products Intended for Reconstitution Any drug product intended for reconstitution and not bearing an expiration date for the unreconstituted product and another expiration date for the product after reconstitution is considered to be out of compliance with There must be separate stability studies to support each expiration date. Supportive Stability Data Number and Size of Batches Initial stability testing by accelerated testing may be performed on a batch smaller than the normal production size as long as the batch is produced by similar equipment as would be used for regular production.

Generally, the placing of three initial batches into the long term stability program is considered minimal to assure batch uniformity for establishing an expiration date. Since a dosage form is a complex unit and there are continued variables in the production process, such as change in personnel, raw material lots and suppliers, and equipment, it is imperative that stability studies are not limited only to initial production batches but a portion of annual production batches be the subject of an ongoing stability program.

Accelerated Studies When accelerated stability studies are performed, one batch may be adequate in order to establish a tentative expiration date.

Beyond Use Dates 2017