The goals of the summit were to: Characterize the spectrum of activities from traditional pharmacy sterile compounding to manufacturing. Identify the drivers of outsourced sterile compounding. Identify current gaps in regulatory oversight and recommend strategies to ensure the quality and safety of compounded sterile preparations. Summit participants included representatives from health professional organizations, large and small health systems, companies providing compounded sterile preparations CSPs , experts in compounding and manufacturing quality, group purchasing organizations and other collaboratives representing health systems, and the U. Centers for Disease Control and Prevention. Representatives from the U. Food and Drug Administration FDA , a state board of pharmacy, and an organization representing member state boards of pharmacy also participated in portions of the meeting. Clarify the role of federal and state bodies with oversight of sterile compounding, with an emphasis on developing clear and consistent processes that will ensure the safety of CSPs regardless of origin.
United States District Court, E. Mantell , United States Attorneys Office. On July 14, , defendants Gerald Tighe and Stephen Kalinoski each pled guilty to a one-count superseding information that charged them with conspiracy to commit wire fraud. At sentencing, on December 19, , the Court gave each defendant the same noncustodial sentence: Although the defendants did not oppose restitution prior to sentencing or at their sentencing hearings, the Court reserved decision as to restitution at that time, and a hearing on restitution was scheduled for February 16,
Assuming physical stability, can I apply extended dating to a CSP that is mixed in a class 5 hood inside a class 7 clean room under the new USP > chapter guidelines?
Results of our survey on drug storage, stability, compatibility, and beyond use dating March 22, ISMP would like to thank the practitioners, mostly pharmacy directors and managers, staff pharmacists, clinical pharmacists, and medication safety pharmacists, who responded to our recent survey on drug storage, stability, and beyond use dating of injectable drugs. We conducted the survey to learn more about what resources pharmacists rely on to guide drug storage, stability, and beyond use dating.
We were specifically interested in learning about conditions that may result in unnecessary waste of drugs during the ongoing drug shortage crisis or waste of very expensive medications given the ever rising cost associated with healthcare. CMS is reviewing this matter further. We are hoping the results of our survey, as described below, provide CMS with some baseline information to support its review process.
About a quarter of respondents reported that, upon request, manufacturers never or rarely provide newer in-house data on extended beyond use dating that differs from the package insert. Numerous respondents also noted that a conflict of interest may exist for the drug company regarding additional drug testing or acknowledgment of external testing related to storage, stability, compatibility, and beyond use dating.
They remarked that, once a drug has been approved, the company may have little incentive to conduct additional testing on its products because the results may lead to required, costly labeling package insert changes and a reduction in sales if the beyond use dating is extended. FDA considers this a practice-related issue. Sixty-one percent of respondents said they feel compelled to discard injectable medications according to the package insert, knowing it differs from information in national compendia.
These respondents collectively reported more than different medications that they felt compelled to discard despite newer evidence that extends the stability and beyond use dating or alters the storage, dilution, or compatibility directions documented in the package inserts. Examples include bleomycin, cytarabine, DAPTOmycin, dacarbazine, diazepam, epoetin alfa, various insulin analogs, and various electrolytes.
Drug Expiration Dates – Are Expired Drugs Still Safe to Take?
Five Appendices — shall vs. Pharmacopeia USP is to provide the practice standards to help ensure that compounded sterile preparations are of high quality, and is for the pre-administration phase of sterile preparations. It describes the CSP requirements guidelines, USP procedures and compliance for CSPs and sets the standards that apply to all settings in which sterile preparations are compounded. Adherence to will reduce the potential for contamination caused by unclean environment, pharmacist error, lack of quality control, incorrect beyond-use dating and other factors.
The standard applies to anyone who prepares CSPs and all places where they are prepared.
BEYOND USE DATING FOR STERILE COMPOUNDING Beyond Use Date (BUD) is very different from expiration date. USP Chapter defines BUD as the date or time after which a compounded sterile preparation (CSP) may not be stored or If the BUD is extended beyond the allowances by USP Chapter , a sterility test that complies.
Methods A review and discussion of compounding issues with supporting literature, clinical experience, illustrations, and expert opinion. Results Closer examination of the events surrounding the recent clusters of infectious endophthalmitis cases occurring after the intravitreal injection of bevacizumab suggest that the vision loss is not the result of the drug or the injection technique, but rather of the compounding procedures used to prepare the syringes containing the bevacizumab.
Noncompliance with recognized standards and poor aseptic technique are the most likely causes of these outbreaks. The key to preventing these catastrophic occurrences depends on the implementation of and strict adherence to United States Pharmacopoeia Chapter requirements. Conclusions Recommendations arising from a root cause analysis of infectious endophthalmitis outbreaks should focus on the procedures used by pharmacies to compound bevacizumab.
Microbial contamination of bevacizumab-containing syringes prepared from the same vial of drug can be avoided by using a single vial of bevacizumab for each eye or by following strict adherence to United States Pharmacopoeia Chapter requirements when compounding a single vial of bevacizumab into multiple syringes. A specialist in ophthalmic compounding, he was the first to compound bevacizumab for intraocular injection and his protocol is currently used worldwide.
See Accompanying Article on page
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Bing CM, ed. Extended stability for parenteral drugs, 4th ed. Bethesda, MD: American Society of Health-System Pharmacists; Bing CM. Storage and Beyond Use Dating (Chapter 10) in Compounding Sterile Preparations, 3rd ed. Bethesda, MD: American Society of .
A total of SHS captures including recaptures were made in the Rewa Delta from September to March by using gill nets. Of the captured individuals, individuals were tagged and released. Ninety three out of of the individuals we captured during our survey died 9. Of these 93 individuals 20 were tagged. According to the definition of a shark nursery area currently accepted by the scientific community our results unambiguously confirmed that the Rewa Delta is a nursery ground for SHS because the following conditions were met: A Sharks are more commonly encountered in nursery the area than in other surrounding areas A significant spatial difference in the number of individuals caught was found among the sites over 18 months of the study.
There were also significant differences in the number of each age class utilizing the area throughout the year.
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? Are there recommendations about the best way to store my medications? Which drugs should never be used past their expiration date?
encouraged by USP to support dating periods exceeding 30 days.3 It is clearly the responsibility of compounding personnel to assure that any data used to determine BUDs of preparations is applied consistently and is sufficiently conservative to protect the patient receiving the preparation.
Some of the most common issues for healthcare providers today include: PharMEDium was among the first entities to voluntarily register with the U. The company works with hospitals and ambulatory surgery centers to promote patient safety while easing the supply chain burden to ensure hospitals and surgery centers have the drugs they need. Since the passage of the Drug Quality and Security Act in November , the FDA has been charged with federal oversight of sterile compounding facilities and conducts rigorous inspections.
The Drug Quality and Security Act eliminated the patchwork of state laws and provided clear oversight to regulatory bodies. Prior to the federal law passage, regulatory bodies at the state level licensed facilities to compound medications. The inspection process varied by state. Many times, there were questions as to whether manufacturing regulations were appropriate or should outsourcing facilities be regulated as a pharmacy.
The amount of oversight is greatly enhanced.
U.S. v. TIGHE
Closed but untaped mL bottles have a shelf life of 4 years. Closed but untaped mL bottles have a shelf life of 21 months. Transpiration loss occurs mainly around the cap circumference and not through the container walls.
Compounding for Phase 1 Investigational Studies: USP General Chapter is currently being developed to provide guidance on compounding investigational preparations for phase 1 clinical studies. The chapter will describe considerations such as training, facilities, equipment and components, release testing, quality assurance, quality control and documentation for compounding investigational .
Both the amplitude- and the phase-modulation of the modes are anti-correlated in V The other three stars show, however, quite diverse modulation properties of the radial modes. We find no evidence of an influence of the radial modes and their modulations on each other. The only common features are that both modes are modulated in each Blazhko RRd star, the rapid phase change either positive or negative is connected to the amplitude minimum of the respective mode a typical feature of Blazhko stars , and that the amplitude and amplitude variation of the fundamental mode are larger than or the same as for V99 those of the overtone mode.
The modulations of the F and 1O modes of V13 are anticorrelated; no connection between the modulation properties of the modes in the other stars is evident. Standard image High-resolution image Export PowerPoint slide The phase differences of the maxima of the overtone mode and the nearest maxima of the fundamental mode are plotted in the bottom panels of Figure 1. As the period ratios do not equal 3:
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The United States Pharmacopeia (USP) General Chapter > “Pharmaceutical Compounding—Sterile Preparations” was pub – lished in the fall of .
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The immediate-use provision in USP allows the preparation and dispensing of CSPs without the need to be in compliance with the requirements as stipulated in USP for low-risk level CSPs (e.g., ISO Class 5 hood or isolator, facility design and environmental controls, and personnel cleansing and garbing).
For further information about unapproved drugs, click here. Ascorbic Acid vitamin C is a water-soluble vitamin. It occurs as a white or slightly yellow crystal or powder with a light acidic taste. It is an antiscorbutic product. On exposure to air and light it gradually darkens. In the dry state it is reasonably stable in air, but in solution it rapidly oxidizes.
Ascorbic Acid is freely soluble in water; sparingly soluble in alcohol; insoluble in chloroform, ether, and benzene. The chemical name of Ascorbic Acid is L-ascorbic acid. The molecular formula is C6H and the molecular weight is The structural formula is as follows: Ascorbic Acid Injection is a clear, colorless to slightly yellow sterile solution of Ascorbic Acid in Water for Injection, for intravenous, intramuscular or subcutaneous use.
Ascorbic Acid mg, Disodium Edetate 0. In humans, an exogenous source of ascorbic acid is required for collagen formulation and tissue repair. Ascorbic acid is reversibly oxidized to dehydroascorbic acid in the body.
This incident was attributed as a direct link to the lack of proper oversight provided by the state boards of pharmacy. As a result, the Food and Drug Administration FDA has stepped in as the primary regulatory body for regulating the compounding pharmacies and have divided the pharmacies into two sectors: What is A Compounding Pharmacy? In this business model, the facility is prohibited from dispensing for office use which limits the product line to items that the patient can use in their home.
In addition, the facility may not compound large batches which can lead to increased product cost.
USP requires that personnel must be trained and their knowledge and skills verified through testing at least annually at the skill level appropriate to their compounding duties. However, because extending dating, by definition, makes a preparation high-risk, personnel who perform the batch-preparation of CSPs must receive additional training and technique verification at least semi-annually.
The deadly, multistate meningitis outbreak our country is currently dealing with brings much needed scrutiny to the compounding pharmacy business. The scale of the outbreak makes it the worst among a series of fatal or harmful infections and overdoses linked to compounding pharmacies in the U. For example, in , more than patients died after the S. Up until now, there have been adverse events involving 71 compounded products in the past 2 decades, many with devastating outcomes.
Each case has prompted calls for federal oversight of compounding pharmacies, which are not subject to the same controls as drug manufacturers but whose regulation falls between the state board of pharmacy, the state department of health, and the FDA. While the present outbreak cannot be considered an outlier event, it should certainly be the very last event before enacting federal legislation to protect the public from preventable compounding errors and contamination.
The magnitude of the current tragedy must serve as a wake-up call for Congressional action, just as it was in the above tragedies. In April, , I blogged about the need for federal and state oversight after 9 patients died in Alabama due to contamination of nutritional solutions made by a compounding pharmacy. Since , FDA has issued 49 warning letters to compounding pharmacies around the country for significant safety violations; 19 previous deaths may be associated with these pharmacies.
As we move forward and learn from the most recent outbreak, Congress must act quickly to address the need for laws on the federal level to fill in current regulatory gaps. Regulations must be equal to what is required of pharmaceutical companies when compounding pharmacies dispense in mass quantities without individual patient prescriptions, or manufacture sterile products from non-sterile active ingredients.
These pharmacies must be registered with FDA and subject to periodic inspections. FDA must clearly articulate requirements for IV compounders to register, regulate them and subject them to periodic inspections. We believe Congress should undertake a thorough examination of the construct of state boards of pharmacy, and examine their roles associated with keeping patients safe.