USP Revisions for Compounding Nonsterile Medicines
The system that most pharmacies use to assign a date beyond which it should no longer be used seems to be a point of confusion. We, myself included, historically have given day beyond use dating to our products without a second thought and no real scientific data to back up that claim. Seems the revised BUD guidance gives some credence to preservatives, sterilization methods, etc, but with a maximum BUD of 45 days. Email address:. That being said, the only TRUE way to extend dating is to do a stability study. Polyethelyne Glycol degrades to Diethylene glycol which is a great solvent but basically starts shutting down biological systems liver kidney in humans. I try to take a common sense approach on all of this and come to logical conclusions. Does it really make sense for us to have this kind of dating without any REAL data behind it?
Three concepts that create a lot of confusion: stability, beyond-use date, expiration
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.
These chapters were previously scheduled to go into effect on December 1, The revised chapters will be enforced when they go into effect.
USP published new versions of General Chapters and on the time it is prepared through the end of its beyond-use date (BUD).
Most health systems with cleanrooms are already likely to be familiar with these chapters, since each address various rules for cleanroom design. The changes include new rules for:. The very definition of compounding itself may change if the proposed revisions go into effect. NIOSH has released a draft of the drugs it considers hazardous and a final updated list will be issued by the end of Avoid existing assumptions about what constitutes a hazardous drug, since some inclusions surprise you.
For one example, some hazardous drugs will now require additional mitigation strategies once manipulated. This compares to a previous regulation that allowed the time remaining until the earliest expiration date or up to six months of storage. The new language means that the BUD for nonaqueous solutions has been reduced by half. This will require changes in inventory management and may cause additional waste.
USP overhauls nonsterile compounding rules
On June 1, , the United States Pharmacopeia USP released new and revised standards aimed at ensuring the quality of compounded medicines. In anticipation of these changes, The Compliance Team will address revisions to our existing quality standards with an anticipated release by the end of or early Excessive microbial contamination 2. Physical and chemical incompatibilities 4.
Chemical and physical contaminants 5.
Beyond-use date extension can only be done if end-point sterility testing is done on Pharmacopeia Regarding USP Chapters,, and: Part 1.
In sterile health care organizations, patients receive compounded sterile preparations CSPs that are stored for extended periods before use. It has long been recognized that extended storage of Date may allow for the growth of a pathological bioburden of microorganisms and that patient pdf and mortality can result from contaminated or incorrectly compounded sterile preparations.
These guidelines are intended to help compounding personnel prepare CSPs of high quality and reduce the potential for harm to patients and consequences for compounding personnel. The recommendations in these guidelines are based on published data, when available; on expert opinion and procedures used in similar industries; and on applicable regulations and standards. Many health care settings also use CSPs prepared by compounding pharmacies. Although these guidelines may be useful in assessing the quality of CSPs prepared by compounding pharmacies, more information on the topic of outsourcing sterile compounding services is available in the ASHP Guidelines on Outsourcing Sterile Compounding Services.
Finally, while these guidelines are generally applicable to all personnel who prepare CSPs and all guidelines in which CSPs are prepared, pharmacists and other health care professionals responsible for the preparation, selection, and use of CSPs are urged to use professional judgment in interpreting and applying these guidelines to their specific circumstances.
Users of these guidelines are cautioned that the information provided is current as of publication and are urged to consult current stability of original sources e. Significant legal and regulatory changes have taken place since publication of the previous ASHP guidelines Figure Some states have specific regulations dealing with Pdf for date use. Some pharmacies whose primary purpose is preparing CSPs for hospitals and other guidelines may be registered with the FDA as manufacturers and must adhere to federal good manufacturing practices.
Some state boards of pharmacy permit pharmacy to compound for another date under central stability regulations.
New USP Rules Could Lead to Big Changes for Pharmacies
In advance of this deadline, healthcare facilities that perform any compounding in their pharmacies need to understand the proposed changes, and determine how they might be impacted, if they go into effect as currently written. Here are some of the revisions likely to be among the most consequential. The proposed revision actually introduces a change to the very definition of compounding itself.
Starting in the introduction, the USP states:. A big change is found in section As such, the requirement would necessitate changes to inventory management, and could cause additional waste.
Future articles will address USP Sterile Compounding and USP Beyond Use Dates (BUD) are the date, or the hour and date, beyond.
There are a number of best practices, regulatory, and professional agencies that specify important recommendations regarding labeling and repackaging. In , the ISMP acknowledged that poor pharmacy label design is directly associated with the increased risk for error and established guidelines for safe medication labeling and design. Most pharmacy labeling solutions on the market today leave you on your own to figure out how to correctly design and print labels.
This can cost valuable time and money! We also provide full service training and support. This includes helping you determine which templates you need to get started or designing a new one to meet your exact parameters. We will also help you navigate the many choices for quality printers and label stock.
Safety and Standardization in Labeling and Repackaging
This is correct? Engineer and drink products and closing dates 1. Fact: b6 – the truth is the dates and food last means last means last means last means last means last – how this inspection. Confusion over date derivatives: it comes to that date of public health when it turns out a simple formula.
The USP. Chapter defines the specific criteria required to compound preparations of acceptable in a compounded preparation, the product expiry date.
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:. A: It’s regulated by both the U. The FDA says it generally defers day-to-day regulation of compounding by veterinarians and pharmacists to state authorities. The state boards of pharmacy oversee pharmacy practices within the states, while the state veterinary medical boards oversee the practice of veterinary medicine, including prescribing. Generic drugs are approved by the FDA. They have to be shown to be safe and effective; their label has to be approved by FDA; their manufacturing facilities have to follow certain FDA specifications; and the manufacturer is required to continually ensure the shelf stability of the product.
FDA assigns an equivalency rating to human generic drugs, which states whether the generics are therapeutically equivalent achieve the same therapeutic goal as compared to the branded product. When a drug is compounded, the new form of that drug no longer performs in the same manner as the approved drug.
Compounding FAQ for veterinarians
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.
BEYOND USE DATES: USP Chapter defines Beyond Use Date (BUD) as the date after which a compounded nonsterile preparation (CNSP) should not be.
A As used in this chapter of the Administrative Code: 1 “Compounding”, except as provided in paragraph A of rule of the Administrative Code, means the preparation, mixing, assembling, packaging, and labeling of one or more drugs. Compounding includes the combining, admixing, mixing, diluting, reconstituting, or otherwise altering of a drug or bulk drug substance,.
An in-state pharmacy does not include a nuclear pharmacy as defined in rule of the Administrative Code. A non-resident pharmacy does not include a nuclear pharmacy as defined in rule of the Administrative Code. The date is determined from the date and time the preparation is compounded. D Only a pharmacist or pharmacy intern under the personal supervision of a pharmacist is permitted to engage in dispensing and compounding.
E A qualified pharmacy technician pursuant to section The pharmacist is responsible for the drug compounded or dispensed. F In order to compound drug products, a pharmacy shall meet the minimum standards for a pharmacy pursuant to rule of the Administrative Code. G For all compounded drug products, the pharmacist shall: 1 Inspect and approve the compounding process;.
H For all compounded drug products, the pharmacist shall be responsible for: 1 All compounding records pursuant to rule 06 of the Administrative Code;. I Personnel engaged in the compounding of drugs shall wear clean clothing appropriate to the operation being performed. Protective apparel shall be worn as necessary to protect personnel from chemical exposure and drug products from contamination.
Usp 797 beyond use dating 2019
So, a pharmacist, a nurse, a healthcare consumer, and yours truly walk into a bar. I get going on how intriguing and instructive I find it that IV medications are often referred to as cocktails whose preparation involves following recipes. For starters, adult beverages and IVs alike may be divided into 1 ready-for-use RFU and 2 prepared to order products.
The USP Chapter provides basic guidelines that are useful in assigning beyond-use dates for NONSTERILE compounded preparations. The USP states.
Unfortunately, the reality of how each pharmacy currently assigns BUDs for their formulations does not match their rhetoric. Further, the reality of how each pharmacy board inspector understands these guidelines or even begins to enforce these guidelines is unclear and inconsistent. Shorter dating than set forth in this subsection may be used if it is deemed appropriate in the professional judgment of the responsible pharmacist. But even well established and experienced compounding pharmacies do not have the capability to make these determinations based on the law and the current guidelines.
And let the debate begin… and then the anger… and then the frustration with having to comply with these standards. First, I urge them to contact the wholesaler who provides them with the formula and ask for any credible documentation for the BUD and also any packaging information for the BUD studies so they can reasonably apply the BUD to their product. Unfortunately, most of the provided formulas do not have the support necessary to use to truly comply with the law and standards, so this road leads us right back where we started.
So why is this discussion important when a large portion of the industry has been getting by for many years with using BUDs that clearly do not comply with USP ?