Upon receipt of a prescription for such a preparation, pharmacists or other qualified individuals working under the authority and supervision of a physician compound the drug formulation and dispense it to the patient. For convenience, a limited bulk quantity of the special formulation may be compounded in anticipation of future dispensing requirements. Such medical and pharmacy practices are regulated by state boards of medicine and pharmacy. Physicians who prescribe a drug that must be compounded extemporaneously bear the professional responsibility to base its use on sound scientific and medical evidence. Pharmacists and physicians who compound or oversee the compounding of drug preparations on prescription orders, bear the professional responsibility to ensure that the preparation meets prescribed and appropriate standards of strength, quality, and purity. As a result, these radionuclides are usually produced using particle acceleration techniques e. The radionuclides may then be synthetically incorporated into the final PET radiopharmaceutical for subsequent patient administration. The following requirements address the compounding of PET radiopharmaceuticals for human use see also Automated Radiochemical Synthesis Apparatus.
USP Establishes Elemental Impurities Implementation Dates
Classification of air cleanliness. For example, particles of 0. Barrier isolators provide a suitable environment by restricting any ambient air from the work chamber.
But, the term still held a lot of weight.
The container used depends on the physical and chemical properties of the compounded preparation. Sterility Assurance of sterility in a compounded sterile preparation is mandatory. Stability Criteria and Beyond-Use Dating The beyond-use date is the date after which a compounded preparation is not to be used and is determined from the date the preparation is compounded. Because compounded preparations are intended for administration immediately or following short-term storage, their beyond-use dates may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products.
Compounders are to consult and apply drug-specific and general stability documentation and literature when available, and are to consider the nature of the drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy when assigning a beyond-use date see Expiration Date and Beyond-Use Date under Labeling in the General Notices and Requirements.
Beyond-use dates are to be assigned conservatively. When using manufactured solid dosage forms to prepare a solution or aqueous suspension, the compounder is also to consider factors such as hydrolysis and the freeze-thaw property of the final preparation before assigning a beyond-use date. In assigning a beyond-use date for a compounded drug preparation, in addition to using all available stability information, the compounder is also to use his or her pharmaceutical education and experience.
When a manufactured product is used as the source of active ingredient for a nonsterile compounded preparation, the product expiration date cannot be used to extrapolate directly a beyond-use date for the compounded preparation. However, a compounder may refer to the literature or to the manufacturer for stability information. The compounder may also refer to applicable publications to obtain stability, compatibility, and degradation information on ingredients.
All stability data must be carefully interpreted in relation to the actual compounded formulation. At all steps in the compounding, dispensing, and storage process, the compounder is to observe the compounded drug preparation for signs of instability.
Sodium nitrite (USP)
Descriptions of testing procedures for raw materials and finished products. Any other information that may be indicative of the quality of a given finished drug product. There should be no history of recurring product recalls indicative of deficient quality control procedures. The supplier should permit visits during normal business hours by the pharmacist to inspect its manufacturing and control procedures.
To the extent possible, all products should be available in single unit or unit dose packages.
Although USP no longer releases new lots labeled as Authentic Substances, you may still receive a lot released prior to this change.
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.
Contact Reference Standards Technical Service rstech usp. Products that become available within 30 days of your order will be shipped to you automatically. If the product becomes available after 30 days, USP will send you a Notice of Availability to get your confirmation before shipping the order.
United States Pharmacopeia
How often should volumetric solutions be re-standardized? This decision is made based on the stability of the solution, its intended use and storage conditions. If this information is not stated in the text in a USP monograph for the particular volumetric solution, then it is up to your lab to define this frequency. You need to have experimental data to support your decision. Do not assume arbitrary frequencies.
How do I establish expiry dates for solutions, buffers, etc.?
Now the guidelines give more details about manipulating unapproved drug products, reporting adverse events, registering a facility and repackaging compounded drugs.
An official dosage form is required to bear on its label an expiration date assigned for the particular formulation and package of the article. This date limits the time during which the product may be dispensed or used. However, under no circumstance should the repackaged pharmaceutical preparation’s expiration date exceed the original manufacturer’s expiration date. It is necessary, therefore, that other precautions be taken by the dispenser to preserve the strength, quality, and purity of drugs that are repackaged for ultimate distribution or sale to patients.
The following guidelines and requirements are applicable where official dosage forms are repackaged into single-unit or unit-dose containers or mnemonic packs for dispensing pursuant to prescription. Repackaged dosage forms must bear on their labels expiration dates as determined from information in the product labeling see Preservation, Packaging, Storage, and Labeling section of the General Notices and Requirements.
Each single-unit or unit-dose container bears a separate label, unless the device holding the unit-dose form does not allow for the removal or separation of the intact single-unit or unit-dose container therefrom. A refrigerator or freezer shall not be considered to be a humidity-controlled environment.
This is significant because it is the first time in the long history of USP standards that this topic has been addressed. But in order to fully understand the depth and scope of this new chapter, the history of its inception must be covered first. The Packaging and Distribution Expert Committee is charged with the maintenance, review and updating of the appropriate chapters covering the storage and distribution of drug products and starting materials.
For instance, while GDP is an overarching subject, individual components e.
Regulatory authorities may enforce the standards presented in the USP and NF, but because recognition of the USP and NF may vary by country, users should understand applicable laws and regulations.
For general inquiries, please contact Mylan Customer Relations at or customer. Mylan Customer Relations hours of operations are Monday through Friday, 8 a. What is the reason for the supply constraints? Over the past few months, there has been intermittent supply of EpiPen at wholesalers and pharmacies. Pfizer is working hard to increase production and stabilize supplies, but until this occurs, supplies of EpiPen 0.
Mylan sells and distributes EpiPen 0. Mylan is not the manufacturer. When will the supply constraints be fully resolved? Pfizer anticipates supply will stabilize in the fourth quarter of What are Mylan and Pfizer doing to resolve the supply constraint? Pfizer is working tirelessly to increase production. Mylan is expediting shipments upon receipt from Pfizer. We also are working closely with Pfizer to stay informed of anticipated shipments and are maintaining regular dialogue with health authorities to provide frequent updates on supply status.
Dissolution Testing of Nutritional Supplements
FDA Abstract As the third part and final part of this series, this article focuses on future directions and challenges faced by the USP excipient Up to-Date initiative with regard to excipients. The article will provide the key findings of the USP Excipients Workshop held in November that focused on several topics, including challenges involved with introducing new or missing NF excipient monographs and opportunities to update USP excipient standards used in injectable and biologic dosage forms.
Excipients are often complex substances that, within their definition and specification in a USP monograph, can exhibit relatively wide variation in composition. This article also explores the challenges involved in updating current monographs to improve characterization of excipient composition and thereby assure that impurities, concomitant components, and certain allowed additives are properly accounted for and controlled.
Introduction The United States Pharmacopoeia — National Formulary USP—NF currently provides tests, procedures, and acceptance criteria that help to ensure the quality and safety of excipients used in drug products and dietary supplements marketed in the U. The USP—NF defines pharmaceutical excipients as substances other than the active pharmaceutical ingredient API that have been appropriately evaluated for safety and are intentionally included in a drug delivery system.
Selection of the appropriate tests and specifications that are necessary to ensure consistent and reliable excipient performance requires an understanding of the formulation and manufacturing processes, the dosage form performance requirements and the physical and chemical properties of each ingredient in the dosage form.
Note that this requires knowing what the true value is. Adjuvant A material that enhances the action of a drug or antigen Alcohol Unless otherwise specified, ethyl alcohol ethanol. Concentration is normally in percent by volume. Analyte The specific substance to be determined in an assay or analysis Assay, Analysis Properly, an ‘assay’ determines how much of some particular material is in the sample such as an assay for the Aspirin contentof Aspirin tablets.
An ‘analysis’ generally determines more or less everything in the sample. An analysis of a rock would determine the content of calcium, magnesium, lithium,. Both assays and analyses generally use similar procedures and instruments, but an analysis may be qualitative, reporting what is detected, or quantitative, reporting how much is found. An assay is always quantitative. Bioavailability Indicates measurement of the rate and amount of drug that reaches the general circulation from an administered dosage form.
Bioequivalence Indicates that a drug in two or more similar dosage forms reaches the general circulation at the same relative rate and the same relative extent. Dissolution Generally, dissolving; but specifically, a USP test which determines how rapidly the active ingredients of a dosage form dissolve. The test is generally done with six tablets in containers with very specifically defined dimensions, stirring mechanisms, etc.
Dosage form A pharmaceutical product as produced for use tablet, capsule, etc. Excipient Any component other than the active substance s that is intentionally added to the formulation of a dosage form; “added substance”.
Observations in the Proposed USP Revisions
Oxygen, while frequently encountered in Pharmaceutical Manufacturing, is not an excipient; but rather because of its reactivity, is some sort of oxidizing reagent. Oxygen has its own USP monograph. It is therefore important to ensure that all steps of the Pharmaceutical Manufacturing process incorporate processes, materials and equipment which minimize any possibility for the introduction of adulterating substances.
However, multiple procedures may be included in particular monographs specifically for the purpose of assuring the availability of an appropriate procedure for a particular product.
Are we required to show them these files? An FDA employee may request under the requirements of the regulations, management with executive responsibility certify in writing that management reviews and quality audits have been performed and documented, the dates on which they were performed, and that “any required corrective action has been undertaken.
While periodic preventative maintenance is always a good business practice, there is no regulatory requirement that the analyzer must be returned to the factory for recertification as long as the analyzer is performing properly. Who can we legitimately sell medical gas products too? Medical Gas Products are prescription legend drug products and can only be sold to the following entities: FDA has agreed to exercise enforcement discretion regarding the sale of Nitrogen NF to firms that install hospital medical gas systems.
NFPA 99 specifically requires the use of Nitrogen NF in purging and pressure testing of healthcare medical gas piping systems. NFPA 99 is the national standard for health care facility medical gas piping systems, and FDA participated directly in the development of elements of the code. While the practice seems to be acceptable in the FDA’s eyes at this time, it is recommended that if you are going to sell to this market, you obtain a letter from the plumbing company stating that “They understand they are obtaining a drug product and will only use it for the intended purpose of purging and pressure testing of healthcare medical gas piping systems.
They are constructing “safe rooms” that are designed to be used in case of events like the one in West Virginia when the miners were trapped underground. It will be used to support life, however it will not be dispensed or provided by an emergency responder or licensed healthcare provider.