USP Standards for Compounding Sterile Preparations

This helps veterinarians that are struggling with drug shortages, price gouging, and sourcing difficult to find medications. In fact, the FDA has encouraged hospitals to use a B compounding service to meet these specific needs. Read More The main difference between B and A facilities, and a major practice of CGMP, is the requirement for every process to be validated in a B outsourcing facility. Multiple batches must be made and submitted for testing and stability studies, before any new product can be brought to market. Although production time frames may be prolonged, this certifies that batches made during normal production is dependable in quality and meets the standards set by the FDA and CGMP. Testing and validation methods must also guarantee accuracy according to USP standards.

Summary of USP for Compounding Sterile Preparations

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.

USP is a far-reaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound .

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.

At issue here is assuring that sterility testing of a sample of the batch is representative of every other item in the batch; not whether or not a deviation in the process was likely to lead to contamination. It is also possible for a deviation to be something that would decrease the likelihood of contamination for example, performing extra glove decontamination which poses the risk that testing would indicate higher quality than the rest of the batch actually possesses.


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.

We evaluated the sterility of medications that are commonly administered by continuous infusion to pediatric patients. Because frequent manipulation of infusion and administration sets may predispose the patient to adverse events, we evaluated sterility for extended beyond use dating up to 72 hours.

USP Chapter > provides for surpassing the Microbiological Beyond Use date limits when a batch of a manually-compounded sterile preparation is subjected to the official USP Chapter sterility test and.

The current USP Chapter on sterile compounding had three levels of safety protocols for compounding reflecting increasing levels of potential risk to patients. Aside from high, medium and lower risk categories, a separate section detailed standards for compounding of allergen immunotherapy, reflecting both how allergen immunotherapy is fundamentally different in nature from other compound administration processes and the comparative safety of the allergen extract compounding and administration.

The draft issued in abandoned the risk-relational approach and characterized all compounding for human injection as equally and inherently dangerous, thus treating allergen immunotherapy the same as radioactive and high-risk compounds. The extraordinary measures required would have made in-office compounding of allergen essentially impossible. The College, AAAAI, AAOA and others immediately responded by submitting thousands of comments expressing concern for both the patient safety and patient access to allergen immunotherapy unless in-office compounding remained feasible.

Extensive feedback focused on the increased risk of anaphylactic shock presented by lack of control of source material, the necessity of extended beyond use dates to make allergen immunotherapy feasible, and the likelihood of significantly increased patient costs and delays of treatment if control over compounding in the office setting was lost. An updated draft Chapter provides standards unique to allergen extract compounding for individual patients.

These standards include updated requirements for personnel qualifications and training; personnel hygiene and garbing; facilities; cleaning and disinfecting; and documentation and labeling. Standards are provided for the set-up, use and maintenance of either approach. In addition to these requirements for the physical space, there are additional requirements for personnel, including having their garbing and hand hygiene evaluated, including fingertip and thumb sampling, at least three times before beginning compounding and at least annually thereafter.


Our in-house team of engineers, architects and designers will provide assistance with the design and qualification process, while our nationwide network of local distributors will complete the construction and installation of your new enclosure. What is USP ? USP is a far-reaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound sterile preparations are prepared, stored, and dispensed.

The purpose of the regulation is to prevent infections in patients using pharmaceutical products, as well as to protect pharmacy staff members that are ordinarily exposed to pharmaceutical products. Below is a summary of the USP regulation. For more information, visit the USP website.

USP > allows for extended dating for all risk levels, so long as a sterility and stability program has been established for that specific preparation. If sterility testing in accordance with USP has occurred and there is evidence to support stability beyond USP >, what is the justification to limiting dating to medium risk? (2).

Define the day rule for multidose vials Demonstrate ways to document compliance On one hand, multidose vials are a great way to get more for your money with expensive medications. On the other hand, they can cause multiple complications if staff members are not following very precise procedures. In fact, the best solution for multidose vial complications is not to use them.

This brings up the second problem: Multidose vials have a limit on how long they can be stored after being opened or punctured; typically that limit is around 28 days. Sterile Preparations, requires multidose vials to be discarded 28 days after initial stopper penetration unless the manufacturer specifies otherwise. The vial should be labeled to reflect the penetration date or the beyond-use date. However, the CDC indicates that multidose vials can be used until the expiration date, unless there are concerns with sterility.

Safe Injection, Infusion, and Medication Vial Practices in Health Care, it recommends that facilities develop policies based on one guideline or the other, then follow through with those policies.

Compounded Sterile Preparation

ACA Continuing Education Programs Through educational conferences, seminars, compounding training, webinars and on-demand programs, ACA provides an array of opportunities for pharmacists, technicians, marketers and pharmacy students to obtain information, earn CE credits, and receive valuable networking with independent pharmacy entrepreneurs. ACA can also provide CE accreditation for other organizations.

Educational and Specialty Conferences ACA provides an annual multi-day conference each year with continuing education sessions, social events, induction of new ACA Fellows and members, networking and award presentations. These conferences are held in different areas and in addition to learning, a large focus is on networking and sharing amongst pharmacists, pharmacy technicians, marketers and pharmacy students.

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It is worth noting that several courts have stated that the remedies provided for by the Privacy Act are exclusive, in that a violation of the Act does not provide for any relief in the course of a federal criminal prosecution, see United States v. Additionally, the Privacy Act does not contain any provision allowing the quashing of an IRS summons as a remedy for any alleged failure to provide information as required by that Act.

United States, 43 F. United States, F. July 21, ; see also Harris v. United States, 8 F. But see Hager v. United States, U.


Terminology To get started in this article, there are some terms that should be defined. Prescriptions and over-the-counter medicines and other healthcare products sold in the United States are required to follow the standards in the USP-NF. The USP also sets standards for food ingredients and dietary supplements. Chapters in the USP that are listed as below are considered enforceable, while chapters enumerated as or greater are considered guidelines.

USP – USP Chapter , Pharmaceutical Compounding-Nonsterile Preparations, codifies the rules pharmacists and pharmacy technicians must follow when compounding nonsterile formulations intended for humans and animals.

Cite the new interpretation of the standard requirements related to beyond-use dating of multi- dose vials and the CDC guidelines related to Safe Injection Practices as it pertains to pharmacy practice.

The BUD is determined from the date the preparation is compounded. This date should be based on drug-specific, scientifically valid studies when possible. Things to consider when assigning BUD include: Product labeling Appropriate literature Direct testing Beyond use dating must be carefully interpreted with respect to the actual compounded formulation and conditions for storage and use.

Predictions based on literature are considered theoretical beyond-use dates as the published data introduces varying degrees of assumptions with a likelihood of error or inaccuracy. State and federal regulations also require pharmacists to have written justification for a beyond use date assignment. The only truly valid beyond use date is obtained through product-specific studies supported by scientific data.

These direct testing studies use stability indicating methods SIM to ensure therapeutic effectiveness of compounded drug products. A SIM is a reliable, meaningful, and specific analytical procedure that accurately and precisely measures active pharmaceutical ingredients API by separating the API from its degradation products and excipients. A SIM must be validated for the exact formulation being tested.

High performance liquid chromatograph HPLC is one of the most commonly used techniques for examining the chemical stability of compounded product, but not all HPLC tests are stability indicating.

Batch Compounding Developments from Valiteq and Lab Safety Corporation

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REMINDER: All locations (no exception) are required to hold a license as a terminal distributor of dangerous drugs in order to possess, have custody or control of, or distribute dangerous drugs that are compounded or used for the purpose of compounding.

During the process of parenteral nutrition preparation, aseptic techniques by nursing staff must be guaranteed. Chapter of the United States Pharmacopeia classifies the risk levels of sterile compounding and defines the requirements that must be followed throughout the compounding. To describe the development of an aseptic technique validation procedure for nurses who compound parenteral nutrition at the compounding area Pharmacy Service according to Chapter United States Pharmacopeia guidelines Gregory F Peters, Marghi R McKeon, Richard G Nerburn To comply with pharmacy-practice and occupational safety standards and guidelines “the standards” for the compounding of sterile preparations, a small community hospital that had an extended care unit as part of its facility had to make improvements to its pharmacy.

The typical financial, staffing, and space constraints of the smaller institution had to be accommodated in a comprehensive plan for the low-cost conceptualization, qualification, design, construction, cerification, operation, and maintenance of a modern compounded sterile preparation pharmacy International Journal of Pharmaceutical Compounding https:


Boyle BETHESDA, MD — With increasing shortages of critical chemotherapy drugs — and the funds to buy them — VA pharmacists are constantly looking for ways to enable the medications and money to go farther so that more patients can be treated. As a result, significant amounts of expensive and often hard to obtain drugs are simply thrown away. While the language of USP chapter implies that multiple uses of these vials during the established time frame is permitted, prior to the study, the oncology pharmacy at Walter Reed discarded all unpreserved vials immediately after opening.

During the study period, the pharmacists recorded use of vials of 21 antineoplastic agents.

Sterile Product Compounding References: 1) United States Pharmacopeia Chapter (USP>) The minimum standards for sterile product preparation, storage, and transport Compounding Sterile Product Risk Levels & Beyond Use Dating (BUD) o Assigned based on potential for contamination (microbial, chemical, physical) during.

The revision to that particular chapter was introduced in March , opening a period for public comment and review which closed on July 31, Here are some of the revisions likely to have the greatest consequences. The rule permits a nurse, in an emergency situation, to mix a medication using aseptic technique on a nursing unit, so long as the medication — from the time that they start mixing it until the time that administration begins — is less than an hour.

The Proposed Revision consolidates that into two: Category 1 and Category 2. This shift is likely to have the greatest impact on facilities that were formerly classified as medium-risk compounders, which describes the vast majority of hospitals in the U. Many hospitals, currently categorized as medium-risk facilities, perform compounding using a compounding aseptic containment isolator CACI.

Under the current rules, facilities are able to place these units in unclassified areas and assign usual beyond-use dating extending as far as 45 days to the compounded products made there. In the case of a pharmacy that wants to be able to mix medications and provide greater than a hour beyond-use date at controlled room temperature, that team will now be required to create an area that would bring them up to Category 2 standards. Specifically, this facility might now be required to construct its first compounding suite, comprised of a negative pressure buffer room for hazardous medications , positive pressure buffer room for sterile compounding and an ante room.

Based on some estimates, the cost to construct a brand new compounding suite could reach the neighborhood of one million dollars.

Analysis of Hour Sterility of Common Pediatric Continuous Intravenous Infusions

I can remember only one hospital that succeeded in putting an outdating process in place for open multi-dose vials — it took tons of leverage from leadership and only lasted until the surveyor came back to clear them. So, what are the options? Background There is no requirement to place a date on multi-dose vials when the membrane is punctured — unless, of course, you require it in hospital policy.

Until recently, there were no recommendations to date these vials, leaving the practice up to manufacturer guidelines.

The revision will clarify that the beyond-use date (BUD) in the table “BUD by Type of Formulation” is specific for nonsterile preparations and users should refer to General Chapter Pharmaceutical Compounding—Sterile Preparation for standards on sterile compounding.

For pre-organization period of sterile arrangements – Reduces the potential for pollution brought on by unclean environment, drug specialist blunder, absence of value control, inaccurate past use dating and other factors. Joint Commission requires a hole investigation and activity arrangement for USP consistence.. Ecological and Engineering Solutions, Inc. Pharmacopeia USP For pre-organization period of sterile arrangements – Reduces the potential for sullying brought on by unclean condition, drug specialist blunder, absence of value control, off base past utilize dating and different variables.

Joint Commission requires a crevice investigation and activity anticipate USP consistence. Absolved from specific angles under specific conditions: Hand cleanliness PPE utilized Simple aseptic exchange Contain compelling measure of additive Single patient just Gloves are purified with IPA Vial plugs sterilized Labeling necessities Exemption conceded in view of a review with 27, subjects and no diseases.

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