THE PCCA BLOG

USP 797: Revisions & Impacts, Part 2

Wed, 08 Mar 2023 12:00:00 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

If you missed Part 1 of USP 797: Revisions & Impacts, it can be found here.

ENVIRONMENTAL MONITORING

Personnel compounding Category 3 sterile preparations are required to perform media fills with glove fingertip sampling and surface sampling of the direct compounding area at least every three months, compared to at least every six months for those compounding Category 1 or 2 sterile preparations.

Pharmacies compounding Category 3 sterile preparations also require more frequent monitoring. Thirty days prior to starting to compound any Category 3 batches, viable air sampling must be conducted. Viable air sampling using an impaction device must be completed for each classified area monthly for facilities preparing Category 3 sterile preparations, compared to every six months for facilities preparing Category 1 or 2 preparations.

Surface sampling is required weekly for Category 3 sterile preparations and must be performed in the ISO 5 with each batch of a Category 3 CSP unless using a self-enclosed robotic device. By contrast, for Category 1 or Category 2 preparations, surface sampling is required monthly. Surface sampling must be done in all classified areas and pass-throughs. The sampling must include:

Each classified area, including each room
The interior of each ISO Class 5 primary engineering control (PEC)
Pass-through chambers connecting to classified areas
Equipment contained within the PEC
Staging or work area(s) near the PEC
Frequently touched surfaces

Pharmacies must also conduct viable air sampling and surface sampling:

When new facilities and equipment are certified
After servicing any facility or equipment (see Section 4, Facilities and Engineering Controls)
After identifying any problem (e.g., microbial growth in preparation sterility tests)
After identifying any problematic trends (e.g., failed fingertip/thumb sampling results, failed media-fill testing, or repeated air or surface contamination)
Any changes are made to the facility or processes that could impact the compounding environment (e.g., change in cleaning agents)

Pharmacies must also conduct total airborne particle-count testing in all classified areas during dynamic operating conditions at least every six months for all categories of sterile preparations.

CLEANING AND SANITIZING

Cleaning and sanitizing procedures also changed in Chapter 797 revisions. Pharmacies must clean surfaces prior to disinfecting them unless they use EPA-registered (or equivalent outside the U.S.) one-step disinfectant cleaners that simultaneously clean and disinfect with an appropriate contact time specified by the product.

In a PEC, after cleaning and disinfecting, pharmacies must apply sterile 70% isopropyl alcohol (IPA) to remove any residues of the product(s). Sterile 70% IPA must also be applied immediately before initiating compounding.

Another significant difference exists in the frequency of sporicidal application between Categories 1 and 2 and Category 3 preparations. When pharmacies create Category 3 preparations, they must apply a sporicidal agent to the PEC, including the removable work tray (if applicable), the equipment and work surfaces outside the PEC (pass-throughs and floors) at least weekly. Compounding Categories 1 and 2 preparations require monthly application of a sporicidal agent to all areas.

Along with these changes, the process for cleaning and disinfecting the PEC received more detailed directions. Compounders must:

If necessary, remove visible particles, debris or residue with an appropriate solution (e.g., Sterile Water for Injection or Sterile Water for Irrigation) using sterile, low-lint wipers.
Use a sterile low-lint wiper, apply a sterile cleaning agent followed by a sterile EPA-registered disinfectant, or apply a sterile EPA-registered (or equivalent for entities outside the U.S.) one-step disinfectant cleaner to equipment and all PEC interior surfaces.
Ensure the contact time specified by the manufacturer is achieved.
Use a sterile low-lint wiper, apply sterile 70% IPA to equipment and all PEC interior surfaces.
Allow the surface to dry completely before beginning compounding.

WHAT COMES NEXT

USP 795 and 797 are official and possibly enforceable in your state on November 1, 2023. Revisions to USP 795 and 797 also make USP Chapter 800, Hazardous Drugs — Handling in Healthcare Settings, “compendially applicable” (USP term) and possibly enforceable in many states on November 1, 2023. For more information on Chapter 800, visit pccarx/USP Update/800.

PCCA offers resources to help pharmacies navigate the changing compounding standards and regulatory environment, including our blog on FDA Insanitary Conditions and limited USP training courses at eLearning Compounding Training.

PCCA offers additional resources to our members, including all courses offered in our eLearning Compounding Training, multiple online webinars and training sessions and, for members with Clinical Services, Speakers Bureau to guide, assist and educate compounding pharmacy staff. Members with Clinical Services may also contact our Clinical Services team for help with formulas and other compounding concerns.

The complete version of this article originally appeared in PCCA’s members-only magazine, the Apothagram.

USP 795: Revisions & Impacts, Part 2

Wed, 15 Feb 2023 13:30:23 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

If you missed Part 1 of our USP 795: Revisions & Impacts, it can be found here.

Beyond Use Dates

The concept of water activity receives significant discussion in the revisions to 795. Water activity is a measure of the water that is unbound and freely available to participate in chemical, biochemical or physicochemical reactions, or provides an environment that supports microbial growth. Compounded preparations with a water activity less than 0.6 are considered anhydrous with extended BUDs because they are less likely to allow degradation of API or microbial growth. Discussions on water activity were expanded in 795 revisions and examples of the water activity of various dosage forms were added to the chapter (USP 1112 also discusses water activity).

The maximum potential BUDs that can be assigned to compounded nonsterile preparations without additional stability testing has changed. Nonaqueous topicals, suppositories and troches are now preparations that allow up to 180-day expanded BUDs. Nonaqueous oral preparations can be assigned up to a 90-day BUD. Aqueous dosage forms are separated based on whether or not they have a preservative: non-preserved aqueous dosage forms may be given up to a 14-day BUD when stored at refrigerated temperature; preserved aqueous dosage forms may be given up to a 35-day BUD at room temperature or under refrigeration.

BUDs may extend up to 180 days with a stability study (published or unpublished) using a stability-indicating assay for the API(s), CNSP and type(s) of container closure used. If the BUD of an aqueous preparation is extended, the formulation must also be tested for the performance of the preservative, known as antimicrobial effectiveness testing, according to USP Chapter 51. Revisions to Chapter 795 also permit use of bracketing for stability studies and antimicrobial effectiveness testing. Bracketing is performing tests on a low concentration and a high concentration of API(s). If the formulation passes the tests at both concentrations, the data can be applied to all strengths that fall between the two that were tested.

PCCA has developed over 200 FormulaPlus^™ formulas tested with stability-indicating assays and USP 51 antimicrobial effectiveness (when applicable) for extended BUDs. Some of these are bracketed formulations to help PCCA members address the variety of strengths prescribed by practitioners. FormulaPlus^™ formulas meet all requirements in USP 795 revisions.

THE DESIGNATED PERSON(S)

Responsibility for the performance of the compounding operation created a new role, called the “designated person(s) (DP),” which holds one or more people responsible and accountable for the performance and operation of the facility and personnel preparing CNSPs. The DP(s) is tasked with over 20 areas of responsibility. Note a pharmacy can have one or several persons as the designated person(s), hence the “(s).” These responsibilities can therefore be divided among team members who are appropriate for each responsibility. A few DP(s) key responsibilities are training, documentation and quality control/assurance. While training was discussed above, it is imperative to highlight documentation, including:

Personnel training, competency assessments and qualification records, with corrective actions for any failures
Equipment records (e.g., calibration, verification and maintenance reports)
Certificates of analysis and all documentation required for components not conventionally manufactured
Receipt of components
Standard operating procedures, master formulation records and compounding records
Release-inspection and testing records
Information related to complaints and adverse events, including corrective actions taken
Results of investigations and corrective actions
Records of cleaning and sanitizing the designated compounding area
Temperature logs
Accommodations to personnel compounding CNSPs
Any required routine review (e.g., yearly review of quality assurance and quality control programs, yearly review of chemical hazard and disposal information)

USP 795 references USP 1163 on quality assurance, which can be a helpful resource in developing the required formal written quality assurance and quality control program. This program should establish a system of:

Adherence to procedures
Prevention and detection of errors and other quality problems
Evaluation of complaints and adverse events
Appropriate investigations and corrective actions, such as:

Determining when recalls must be initiated, including procedures to immediately notify the prescriber of a failure of specifications with the potential to cause patient harm (e.g., strength, purity or other quality attributes)
Determining the distribution of any affected CNSP, including other affected lots, and the date and quantity of distribution
Identifying patients who received the CNSP
Recalling any unused dispensed stock and quarantining any remaining stock
Disposing of the recalled CNSP and documentation

PCCA offers additional resources to our members, including all courses offered in our eLearning Compounding Training , multiple online webinars and training sessions and, for members with Clinical Services, Speakers Bureau to guide, assist and educate compounding pharmacy staff. Members with Clinical Services may also contact our Clinical Services team for help with formulas and other compounding concerns.

Look for USP 797: Revisions & Impacts, Part 1 Blog, on March 1.

The complete version of this article originally appeared in PCCA’s members-only magazine, the Apothagram.

Proposed Changes to USP 797

Wed, 03 Nov 2021 14:16:00 GMT

By Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

This article was updated on January 19, 2022.

On September 1, 2021, the United States Pharmacopeia (USP) prepublished their latest proposed revisions to General Chapter 797, Pharmaceutical Compounding — Sterile Preparations. These proposed changes are not in effect now and have several steps to go through before they will become official. The most important next step is the comment deadline for this chapter, which is March 17, 2022. If pharmacies and other stakeholders would like to submit comments about improvements to the proposed changes, they will need to do so by that date.

USP has held two open forums on the proposed revisions, which were opportunities for them to present information about the proposed revisions and their process along with allowing the attendees to ask questions about the proposed revisions. Now is the time for compounding pharmacies to consider how changes to the chapter may affect their practices, patients and procedures to prepare for submitting their comments on anything that they feel should be improved in the proposed revisions.

The most significant proposed revision to USP 797 is the inclusion of Category 3 compounded sterile preparations (CSPs) in addition to the Category 1 and 2 CSPs that were in the previously proposed revision to Chapter 797 in 2019. The addition of the third category involves many other changes in how pharmacies compounding CSPs must operate as well, which I have outlined below.

Beyond-Use Dates

When USP released the previous version of the revised Chapter 797 in 2019, there were two categories of CSPs. In the proposed version released in 2021, these two categories are still present with the same BUDs from the 2019 version. Category 1 CSPs are compounded under the least controlled environmental conditions and therefore are assigned a BUD of 12 hours or less at controlled room temperature or 24 hours or less when refrigerated and meeting the additional requirements for Category 1 CSPs. Category 2 CSPs require more environmental controls and testing than Category 1 CSPs and may be assigned a BUD of greater than 12 hours at controlled room temperature or more than 24 hours if refrigerated, but not exceeding the limits established in Table 11 of the proposed revisions. Please see Table 11 in the proposed revisions to review these BUDs.

In 2019, compounders took notice of the fact that there was not a way to extend the BUDs of Category 1 or 2 compounds. The 2021 proposed version of USP 797, however, has added Category 3 sterile preparations, which can have longer BUDs compared to those for Category 1 and Category 2 sterile preparations that were described originally in the 2019 proposed revisions. Category 3 BUDs are found in Table 12 of the proposed Chapter 797 (below).

TABLE 12: BUD LIMITS FOR CATEGORY 3 CSPs
Compounding Method	Controlled Room Temp. (20 – 25^oC)	Refrigerated (2 – 8^oC)	Freezer (-25 – -10^oC)
Aseptically processed, sterility tested, and passing all applicable test for Category 3 CSPs	60 days	90 days	120 days
Terminally sterilized, sterility tested, and passing all applicable tests for Category 3 CSPS	90 days	120 days	180 days

In order to use these BUDs, the Category 3 sterile preparations have a number of additional requirements beyond Category 2 preparations. The BUD of a Category 3 sterile preparation must be supported by a stability-indicating assay that is validated according to USP 1225, Validation of Compendial Procedures. The sterile preparation relying on this stability study for its extended BUD must be made using the same ingredients and procedures as the study. In addition, the Category 3 sterile preparation must be packaged in a container closure that is composed of the same materials as that used in the study.

Category 3 sterile preparations that are injections or ophthalmic solutions must pass the appropriate particulate matter test once for each formulation. Injections have to pass testing according to USP 788, Particulate Matter in Injections, while ophthalmic solutions have to pass testing according to USP 789, Particulate Matter in Ophthalmic Solutions. Additionally, the container closure systems used for injections and ophthalmic solutions must pass testing according to USP 1207, Package Integrity Evaluation — Sterile Products, for each formulation.

Endotoxin Testing

Category 1 sterile preparations do not require endotoxin testing. Category 2 sterile injectable preparations compounded from one or more nonsterile components and assigned a BUD that requires sterility testing must also be tested for endotoxin content complying with USP 85, Bacterial Endotoxins. If a Category 2 sterile preparation is compounded from one or more nonsterile components but is assigned a BUD that does not require sterility testing, it is not required to have endotoxin testing, although the proposed revisions suggest that it should be tested. Category 3 sterile injectable preparations compounded from one or more nonsterile components must be tested for endotoxin content in accordance with USP 85.

Garbing Practices

Beyond the data and testing supporting the formulation, there are additional requirements for the compounder and others who enter the classified area where Category 3 sterile preparations are compounded. Anyone entering the classified areas used for compounding Category 3 sterile preparations must adhere to stricter garbing practices:

Compounders are not allowed any exposed skin in the buffer room (e.g., face and neck must be covered).
All low-lint garb must be sterile.
Once a compounder leaves a classified area, disposable garbing items must be discarded, and laundered garb must not be reused without being laundered and resterilized with a validated cycle.

Environmental Monitoring

Pharmacies compounding Category 3 sterile preparations have more frequent monitoring requirements. Viable air sampling using an impaction device must be completed for each classified area monthly for facilities preparing Category 3 sterile preparations, compared to every six months for facilities preparing Category 1 or 2 preparations. This is a notable change because the 2019 proposed revisions to Chapter 797 required monthly viable air sampling for facilities compounding Category 2 sterile preparations.

Surface sampling is required weekly for Category 3 sterile preparations and also must be performed with each batch of a Category 3 sterile preparation. By contrast, when preparing Category 1 or Category 2 preparations, surface sampling is required on a monthly basis. Surface sampling must be done in all classified areas and pass-throughs. The sampling has to include:

The interior of the primary engineering control (PEC), which is typically a laminar airflow workstation, as well as the equipment contained in it
Staging or work area(s) near the PEC
Frequently touched surfaces

Pharmacies must also conduct viable air sampling and surface sampling:

When new facilities and equipment are certified
After any facilities or equipment are serviced (see Section 4, Facilities and Engineering Controls)
When any problems are identified (e.g., microbial growth in sterility tests of preparations)
When problematic trends are identified (e.g., failed fingertip and thumb sampling results, failed media fill testing, or repeated air or surface contamination)
When changes are made to the facility or processes that could impact the compounding environment (e.g., change in cleaning agents)

Pharmacies must conduct total airborne particle count testing in all classified areas during dynamic operating conditions at least every six months for all categories of sterile preparations as well.

Cleaning and Sanitizing

Cleaning in the proposed Chapter 797 has received some additional considerations. Pharmacies must clean surfaces prior to disinfecting them, unless they use EPA-registered (or equivalent) one-step disinfectant cleaners that clean and disinfect at the same time. However, the disinfectant must have sporicidal properties, so it’s important to confirm that the disinfectant or one-step disinfectant cleaner is sporicidal. After cleaning and disinfecting, pharmacies must apply sterile 70% isopropyl alcohol to remove any residues.

One significant difference exists in the frequency of sporicidal application between Category 1 and 2 preparations and Category 3 preparations. When pharmacies prepare Category 3 sterile preparations, they must apply a sporicidal agent to the PEC, the equipment in the PEC, work surfaces outside the PEC, equipment outside the PEC, pass-throughs and floors at least weekly. Compounding Category 1 and 2 preparations, on the other hand, require application of a sporicidal agent to all of these areas on a monthly basis.

Along with these changes, the process for cleaning the PEC has received more detailed directions. Compounders must:

Remove visible particles or residue from the equipment and interior surfaces of the PEC with an appropriate solution using sterile, low-lint wipes
Apply a sterile cleaning agent followed by a sterile disinfecting agent (or an appropriate one-step disinfectant cleaner as described above) to equipment and interior surfaces of the PEC using sterile, low-lint wipes
Ensure the cleaning and disinfecting agents are in contact with surfaces for the time specified by the manufacturer
Apply sterile 70% isopropyl alcohol to equipment and all interior surfaces in the PEC using sterile, low-lint wipes
Allow the surfaces and equipment to dry before beginning compounding processes

Next Steps in the Process

After the March 17, 2022, comment deadline, the USP Compounding Expert Committee will to review all submitted comments and determine if they will need to make further changes to the proposed chapter. The committee does not have a defined time period for reviewing the comments submitted, so it’s no possible to accurately predict a future implementation date for the chapter. If the USP Compounding Expert Committee moves to implement the revisions to USP 797, they will provide a six-month implementation window before the chapter becomes official, which would also be when it would become enforceable in most states. The new USP Chapter 797 will also be significant for USP Chapter 800, Hazardous Drugs — Handling in Healthcare Settings, because when the new Chapter 797 becomes official, it will also make Chapter 800 “compendially applicable.” In USP terms, this means that it will also become enforceable in many states. For more information about this chapter, visit the PCCA USP 800 webpage.

Pharmacies and other stakeholders can find the proposed changes to USP 797 on USP’s website along with a link to submit comments on the proposed revisions . PCCA has a wide variety of resources available to help pharmacies navigate the changing compounding standards and regulatory environment. PCCA members can reach out to us today if they would like to see how we can help them move forward in their practices.

Matt Martin, PharmD, BCSCP, is the Director of Clinical Services at PCCA. He joined the PCCA Clinical Services department in September 2014. Matt graduated from Morehead State University with a BS in Chemistry in 2002 and received his PharmD from the University of Kentucky College of Pharmacy in 2006. Prior to joining the PCCA team, Matt worked in pharmacy compounding for more than eight years and has experience with both sterile and nonsterile preparations.

The Top 5 Blog Posts of 2019

Wed, 11 Dec 2019 16:29:00 GMT

By PCCA

And just like that, The PCCA Blog is closing its first full calendar year in the world. Between January and November of 2019, we published 71 blog posts and attracted tens of thousands of readers just like you, many of whom have subscribed as well. Thank you to all of our readers and subscribers for making it a wonderful year. We’re grateful to be able to produce content that professionals in the pharmacy compounding industry find valuable. Below are some of our top-performing posts of the year, reflecting some of the biggest changes that our area of health care is experiencing along with the ever-present need for research-based clinical information.

1. Notable Changes in the New USP <795>
Even though implementation of the new USP General Chapter <795> has been delayed due to appeals, it is still crucial to have a full and nuanced understanding of it. In this post, PCCA Clinical Compounding Pharmacist Matt Martin, PharmD, addresses notable changes to the new USP guidelines and provides some considerations for implementation.

2. An Innovative Option for Hirsutism: Topical Metformin
Clinically, hirsutism “refers to women with excess growth of stiff, pigmented hair (known as ‘terminal hair’) in a male pattern,” explains PCCA Clinical Compounding Pharmacist Sara Hover, RPh, FAARM. But she has exciting news about a potential option for women with hirsutism as well.

3. Oral vs. Topical Estrogen: What the Literature Is Showing about Health Risk
Compounded bioidentical hormone replacement therapy (BHRT) is an important treatment option for women around the world. Colleagues and patients alike come to experts like Pamela Smith, Nat Jones and Sara Hover for guidance. In this two-part post, they cover this all-too-important topic in the BHRT conversation, showing what current literature says about the usage of oral vs. topical estrogen.

4. Upcoming Changes to PCCA Formulas per the New USP <795>, <797> and <800>
The new and revised USP chapters affect many aspects of compounding, including formulas. In this post, PCCA Director of Formulation Development Melissa Merrell Rhoads, PharmD, details the updates we’re planning to make to our formulas based on the new USP guidelines. Pro tip: Look at the types of updates we’re going to make to our formulas as a guide for changes you should consider in your own.

5. Notable Changes in the New USP <797>
The new USP General Chapter <797> implementation is delayed because of appeals just like USP <795>, and that gives compounders more time to become familiar with it. Let Dylan Herr, RA/QA Development Manager at Eagle, help with that. She understands that this version makes significant revisions to the old one, and in this post, she provides you with an overview of those changes and strategies for implementing them.

We’re hard at work planning more content for 2020 that we hope will help you serve patients and grow your business, so keep an eye on The PCCA Blog. If you like what you see, consider subscribing. We’ll send you email notifications when we publish new posts. And if you’re already a subscriber, sit back and relax. We’ll be in touch.

Upcoming Changes to PCCA Formulas per the New USP <795>, <797> and <800> (Part Two)

Wed, 06 Nov 2019 14:52:00 GMT

By Melissa Merrell Rhoads, PharmD, PCCA Director of Formulation Development

As I wrote in the first part of this article, on June 1, 2019, the United States Pharmacopeial Convention published revisions to the compounding Chapters <795> and <797> in the United States Pharmacopeia and National Formulary, which were set to become official on December 1. However, USP later announced that they would postpone that official date because of pending appeals to certain parts of the revised chapters. The revisions in USP <795> and <797> affect the beyond-use date (BUD) that can be applied to compounded formulations, among other standards.

Even though the date when the revised chapters become official is postponed, our Formulation Development department is working on updates to our formulas to be compliant with the new USP standards. We will complete these updates within our formulation database when we are notified of the new official date and contents of the Chapters <795> and <797>, and they will go into effect in our database on the day that they become official. Therefore, it will be important for PCCA members to download the latest versions of PCCA formulas after the date that the new chapters become official (which has not been announced yet), as there will be changes that should be noted and documented for master formulas.

Therefore, we wanted to announce what these future changes will look like. Below is a summary of the formula changes based on the latest version of USP Chapter <797> as it is written currently. We will make further changes as needed based on the appeals outcome, and we will announce those changes as well.

Changes Related to USP <797>
Sterilization Procedures
Section 10 of the revised USP Chapter <797> discusses sterilization and depyrogenation for compounded sterile preparations (CSPs). The method of sterilization plays a role in establishing the BUD for CSPs. The chapter establishes two categories for CSPs: aseptically processed, which are sterilized by filtration, and terminally sterilized, which are sterilized by steam heat (autoclaving) or dry heat. We will update PCCA formulas to reflect these compounding processes and provide specific instructions to render the preparations sterile.

BUDs
Section 14 of USP Chapter <797> discusses the parameters for establishing BUDs for CSPs. Table 11 of the chapter covers the parameters in detail, but the BUDs are based primarily on factors that affect the achievement and maintenance of sterility (risk of microbial contamination). The chapter assumes that CSPs will remain chemically and physically stable within the container-closure systems used. Chapter <797> does not provide specific direction on chemical stability, but requires that compounders consider the chemical and physical properties of the drug and/or its formulation as well as the compatibility of the container-closure system with the finished preparation. Since establishing a BUD per these new guidelines depends on multiple factors, our sterile formulas (outside of FormulaPlus formulas) will no longer assign a specific BUD, but will rather provide the relevant guidelines for compounders to determine the maximum BUD they will be able to assign based on whether sterility testing was performed and passed and the temperature at which the preparation will be stored.

According to USP Chapter <797>, a multiple-dose CSP must additionally pass antimicrobial effectiveness testing in accordance with USP Chapter <51>. After the multiple-dose CSP is dispensed, and upon initially entering or puncturing the container for the first time, “the multiple-dose container must not be used for longer than the assigned BUD or 28 days if supported by antimicrobial effectiveness testing results (see <51>) on the CSP, whichever is shorter.” As an alternative, compounders may dispense the preparation in smaller, sealed, single-use, sterilized and depyrogenated container-closure systems.

According to the new guidelines as they are currently written in USP Chapter <797>, there are no means to extend a BUD beyond the dates listed in Table 11. However, PCCA’s data on our sterile FormulaPlus formulas is still a valuable resource. Since USP <797> does not address chemical stability, these studied formulas provide documented chemical stability and therefore ensure the chemical and physical stability of the preparation. We have 12 sterile FormulaPlus formulas, and several are bracketed studies allowing for a broad range of active ingredient concentrations. PCCA members can view these in the FormulaPlus master list.

Given the significant changes in pharmacy compounding recently, it is as important as ever to ensure that compounders comply with the latest standards. We hope that the updates we will make to our formulas when the new USP <795> and <797> become official — as well as the change we’ve implemented for compliance with USP <800> — will help them do just that. If PCCA members with Clinical Services access have questions about any of these changes, they can contact our Clinical Services department.

Melissa Merrell Rhoads, PharmD, PCCA Director of Formulation Development, received her pharmacy degree from Mercer University in Atlanta, Georgia, in 1995. She currently is involved with and oversees the development and implementation of new formulas at PCCA. She had more than six years of compounding experience with pharmacies in Georgia and Florida prior to joining the PCCA staff in 2004. Her areas of interest include women’s health, veterinary and pain management compounding.

A version of this article previously appeared in PCCA’s members-only magazine, the Apothagram. PCCA members can find a more detailed description of these formula changes in the Fall 2019 issue.

Reference
United States Pharmacopeial Convention. (2019). General chapter <797> pharmaceutical compounding — Sterile preparations. In United States pharmacopeia and national formulary (USP 42nd ed. & NF 37th ed.). Rockville, MD: United States Pharmacopeial Convention, Inc.

New Releases on PCCA Play — August 2019

Wed, 21 Aug 2019 14:34:00 GMT

By PCCA

PCCA Play is our educational media library exclusively for members. It offers tens of thousands of dollars’ worth of educational content available on desktop, tablet or smartphone. PCCA members can also access premium content through a subscription or a la carte rental.

PCCA Play includes everything from main-stage presentations at our live events to our recorded webinars, bringing PCCA members the information they need, when and where they need it.

Now Free
Here is a video that is now free on PCCA Play.

Quality and USP <800> Implementation
This video is a combination of two presentations from the 2017 PCCA Quality Symposium. In part one, Ross Caputo, PhD, Eagle President, covers essential quality assurance elements for compounding pharmacies. In part two, Jerra Banwarth, RPh, FIACP, PCCA Education and Training Manager, discusses USP <800> risk assessment steps in detail.

New Release (at a Great Price)
This new release on PCCA Play is available for just $95.00.

USP <797> — Is Your Pharmacy Ready?
PCCA Clinical Compounding Pharmacist Matt Martin, PharmD, and Eagle Vice President of Operations Megan Jeffrey Liotta, MS, share detailed information about how the revisions to USP General Chapter <797> may affect personnel qualifications, facilities and documentation in compounding pharmacies.

Members, stay tuned to PCCA Play: We’ll release our latest webinar recording on the revised USP <795> soon!