THE PCCA BLOG

Partnerships Between 503A Pharmacies and 503B Outsourcing Facilities

Wed, 27 Nov 2024 15:31:09 GMT

by Bruno Onwukwe, PharmD Candidate, PCCA Clinical Services Intern, and Celeste Zizzamia, PharmD, BCSCP, PCCA Clinical Compounding Pharmacist

Sections of the FDA’s Drug Quality and Security Act (DQSA) distinguish compounding pharmacies (503A) from outsourcing facilities (503B). Due to several factors, many of which are related to drug shortages and the USP 797/USP 800 updates, 503A pharmacies are considering partnering with 503B entities for compounded sterile preparations and/or hazardous materials. We’ll discuss the differences between 503A pharmacies and 503B outsourcing facilities, review Section 503B and summarize how to effectively evaluate 503B compounding pharmacies for a potential partnership.

Key Differences

A 503A designated pharmacy may compound drugs only for an individual patient with a prescription from a qualified provider. In addition, 503A pharmacies are regulated by a state board of pharmacy, which may follow standards set by the United States Pharmacopeia (USP). In contrast, a 503B outsourcing facility does not require a prescription but must adhere to the FDA’s Current Good Manufacturing Practice (CGMP) regulations. Additional differences between 503A and 503B pharmacies related to compounding sterile and/or hazardous materials include:

Description	503A	503B
Standards	USP 797	CGMP
Regulatory Body	State Board of Pharmacy	FDA
Prescription Requirement	Yes	No
Office-Use Compounding	No	Yes
Max Batch Size	250	N/A
Release Testing	BUD Dependent	Yes
Beyond-Use Date	≤180¹	Stability Study Dependent
Interstate Distribution Limit	<5%	N/A

1. For a compounded sterile product (CSP) that has been terminally sterilized, stored frozen, passed sterility and all applicable tests for Category 3.

The 503A pharmacies that compound sterile preparations and/or hazardous materials can benefit from partnering with 503B outsourcing facilities. Forming a partnership may allow the 503A pharmacy to potentially mitigate risks, reduce operational costs, provide expanded services and improve customer satisfaction.

USP chapters 797 and 800 outline the minimum standards for sterile compounding and compounding hazardous materials. Although currently not adopted by all states, 503A pharmacies should consider implementing the USP standards as best practices in patient care and safety — even if doing so may pose challenges. USP updates include increased environmental monitoring, cleaning and disinfecting, garbing requirements, media-fill testing, personnel training, safety and more.

Wholesale Prohibitions for 503B

Section 503B(a)(8) of DQSA discusses the restrictions on wholesaling for outsourcing facilities. Compounded preparations must not be sold or transferred by an entity other than the outsourcing facility that compounded the product — wholesale distributors, pharmaceutical repackagers and relabelers, marketing firms and websites cannot participate in the sale and transfer of compounded preparations. Section 503B(a)(8) does not, however, prohibit the administration of a compounded product in a healthcare setting, nor its dispensing under a prescription.

The FDA Draft Guidance, which determines standard industry practice, clarified in June 2023 that a 503B outsourcing facility may sell its compounded products to a 503A pharmacy. Therefore, 503A state-licensed pharmacies or federal facilities may dispense compounded products in partnership with outsourcing facilities, opening the possibility of increased partnership between the two entities.

Evaluation Criteria for 503B Partnership

Many factors should be taken into consideration when deciding to partner with a 503B outsourcing facility, including:

Appropriate Licensures and Registrations — Investigate whether the 503B facility has appropriate licensure and registration within the states you intend to operate in.
Compliance with Prohibition on Wholesaling — 503As cannot buy from brokers and must directly purchase compounded products from their 503B partner. 503As, however, may use group purchasing organizations (GPOs) to negotiate contract pricing.
Quality Customer Service — Ensure the 503B facility provides reliable information for inventory, processing and shipping.
Regulatory History — Review their track record of FDA Form 483s, FMD-145s, warning letters, product recalls and other events that may call into question their conditions.

In addition, 503B outsourcing facilities must comply with CGMPs to ensure that safe, quality compounds are prepared and dispensed to patients. Some facilities have not been FDA inspected; however, evaluating the facility’s systems will help to discern CGMP compliance. An evaluation should include:

Audits
Facility Certification
Environmental Monitoring Data
Cleaning and Disinfection Program
Quality Unit
Quality Control
Standard Operating Procedures
Investigations
Personnel Training
Validation Activities
Supplier Qualification Program
Master and Batch Production Records
Equipment
Container-Closure Systems
Laboratory Controls (Method Suitability/Validation/Stability Studies)

Many 503A pharmacies that compound sterile preparations and whose state boards of pharmacy implemented USP 797 updates face a pivotal crossroad. Collaboration with a 503B outsourcing facility may pave the way toward a partnership which can increase efficiencies and free up time for pharmacists and technicians to focus efforts in different areas of patient care activities.

More information about FDA-registered outsourcing facilities can be found at https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities.

References

FDA. Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Guidance Document. June 2023. Accessed January 2024 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/prohibition-wholesaling-under-section-503b-federal-food-drug-and-cosmetic-act
FDA. Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. Guidance for Industry. Draft Guidance. January 2020. Accessed January 2024 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-guidance-human-drug-compounding-outsourcing-facilities-under
FDA. 21 CFR Part 21 – Current Good Manufacturing Practice for Finished Pharmaceuticals. Accessed January 2024 at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
USP <797> Pharmaceutical Compounding – Sterile Preparations. 01 May 2024. Accessed January 2024 at https://doi.usp.org/USPNF/USPNF_M99925_08_01.html

These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care or encourage its abandonment.

USP Chapters 795- and 797-Related Changes to PCCA Formulations

Wed, 01 Nov 2023 17:51:51 GMT

USP Chapters 795- and 797-Related Changes to PCCA Formulations

by Melissa Merrell Rhoads, PharmD, PCCA Director of Formulations

USP Chapter 795

USP Chapter 795 describes the full guidelines for pharmaceutical compounding of nonsterile preparations (CNSPs). Specifically looking at the revisions related to BUDs, USP states the BUDs presented “are based on the ability of the CNSP to maintain chemical and physical stability and to suppress microbial growth.” The dosage forms are described as aqueous and nonaqueous based on water activity (aw or Aw). An aqueous preparation is one that has an aw ≥ 0.6 (e.g., emulsions, gels, creams, solutions, sprays or suspensions). Nonaqueous dosage forms have an aw of < 0.6 and are separated into two categories: “nonaqueous oral liquid” and “other nonaqueous dosage forms” (e.g., capsules, tablets, granules, powders, nonaqueous topicals, suppositories and troches or lozenges).

The following shows the revised BUDs and Notes that were added to all PCCA nonsterile formulas.

Non-preserved aqueous (PF) – 14 days refrigerated

Note: According to USP guidelines, “in the absence of an USP-NF Compounded Preparation Monograph or CNSP-Specific Stability Information,” the maximum BUD for a CNSP that is a non-preserved aqueous dosage form with a water activity (Aw) of >/= 0.6 is 14 days stored in a refrigerator, unless such storage affects the physical or chemical properties of the CNSP.*

Preserved aqueous – 35 days

Note: According to USP guidelines, “in the absence of an USP-NF Compounded Preparation Monograph or CNSP-Specific Stability Information,” the maximum BUD for a CNSP that is a preserved aqueous dosage form with a water activity (Aw) of >/= 0.6 is 35 days.*

Nonaqueous (anhydrous) oral liquid – 90 days

Note: According to USP guidelines, “in the absence of an USP-NF Compounded Preparation Monograph or CNSP-Specific Stability Information,” the maximum BUD for a CNSP that is a nonaqueous oral liquid dosage form with a water activity (Aw) of < 0.6 is 90 days.*

Nonaqueous (anhydrous) excluding nonaqueous oral liquids – 180 days

Note: According to USP guidelines, “in the absence of an USP-NF Compounded Preparation Monograph or CNSP-Specific Stability Information,” the maximum BUD for a compounded CNSP that is a nonaqueous dosage form (excluding nonaqueous oral liquids) with a water activity (Aw) of < 0.6 is 180 days.*

*For more information, refer to current USP Chapter 795.

Additional Notes were added to bring awareness to new requirements of USP Chapter 795 during the compounding process. Examples of the notes include visually inspecting all components prior to use and visually inspecting the final preparation, including the container closure integrity. The Notes are not all encompassing. We recommend you become familiar with USP Chapter 795 to ensure compliance with all requirements.

Establishing and extending BUD

Note: USP Chapter 795 sets forth parameters to consider when establishing a BUD and states, “BUDs for CNSPs should be established conservatively to ensure that the preparation maintains its required characteristics to minimize the risk of contamination or degradation.” Stability testing may be performed by an FDA-registered laboratory using a stability-indicating assay to extend the BUD. An antimicrobial effectiveness test (see USP Chapter 51) must also be performed by an FDA-registered laboratory when extending the BUD of an aqueous CNSP.

USP Chapter 797

USP Chapter 797 describes the minimum standards to follow for the preparation of compounded sterile preparations (CSPs) for human and animal drugs. If adopted by your state board of pharmacy, you must meet the requirements of USP 797 to ensure the sterility of CSPs, which include but are not limited to injections, irrigations (for internal body cavities), ophthalmics and inhalations.

Notable changes in the PCCA sterile formulas for USP 797 appear as updates in the compounding procedures and Notes, as well as BUD revisions.

Sterilization and depyrogenation procedures described in Section 10 of USP 797 state, “The sterilization method used must sterilize the CSP without degrading its physical and chemical stability or the packaging integrity. The primary means of sterilizing compounded preparations are: terminal sterilization, which includes dry heat or autoclave, and filtration.” Note: USP 797 requires pre-filtering solutions through a 1.2-micron filter to remove potential particulate matter prior to sterilizing the preparation through autoclave or dry heat.

FILTRATION

Sterilization Procedure for Aqueous Solutions

Filter the solution through a sterile and depyrogenated filter (appropriate for pharmaceutical use) with a nominal pore size of 0.22 micron (PCCA #35-1156) or smaller into an appropriate sterilized and depyrogenated container-closure system. According to USP guidelines, a bubble point test must be performed on the used filter to ensure integrity of that filter. Refer to product specifications for the required minimum pressure.

Sterilization Procedure for Oil or Alcohol Solutions

Filter the solution through a sterile and depyrogenated Teflon® filter (appropriate for pharmaceutical use) with a nominal pore size of 0.2 micron (PCCA #35-2720) or smaller into an appropriate sterilized and depyrogenated container-closure system. According to USP guidelines, a bubble point test must be performed on the used filter to ensure integrity of that filter. Refer to product specifications for the required minimum pressure.

AUTOCLAVE

Sterilization Procedure for Solutions

Filter the solution through a sterile and depyrogenated filter (appropriate for pharmaceutical use) with a nominal pore size of not larger than 1.2 micron (PCCA #35-5755) for removal of potential particulate matter into an appropriate sterilized and depyrogenated container-closure system.

Crimp and seal the serum bottle. Autoclave the preparation until the contents within the vial have reached 121°C, 15 psi for the length of time necessary to render the preparation sterile.

The duration of this process can vary between 20 to 60 minutes, depending on preparation volume and load configuration. This process must be verified and documented with each sterilization run or load through the use of Sterilization Integrators, Steam (PCCA #35-3848) and SporeView® Steam Biological Indicators (PCCA #35-3634) per USP guidelines. Refer to USP 1229, Sterilization of Compendial Articles, for more information.

Sterilization Procedure for Suspensions

When autoclaving compounded suspensions, the initial filter step is removed. After the autoclave process, it is important to provide constant agitation while the preparation is cooling to prevent clumping of the suspension.

DRY HEAT/CONVECTION

Sterilization Procedure for Solutions

Crimp and seal the serum bottle. Dry heat the oil solution in a convection oven until the contents of the vial have reached a temperature of 160°C or higher for a sufficient time to render the preparation sterile.

The duration of time for this process can vary and will depend upon preparation volume and load configuration. Per USP guidelines, this process must be verified and documented with each sterilization run or load through the use of SporeView® Culture Set Biological Indicators (PCCA #35-3632) and temperature monitoring. Refer to USP 1229, Sterilization of Compendial Articles, for more information. Remove from oven immediately and allow to cool to room temperature.

Sterilization Procedure for Suspensions

For dry-heat sterilizing compounded oil suspensions, remove the initial filter step. After the dry-heat process, provide constant agitation while the preparation is cooling to prevent clumping of the suspension.

MULTIPLE DOSE COMPOUNDED PREPARATIONS

USP 797 requires preserved multiple-dose CSPs: a multiple dose CSP must be prepared as a Category 2 or Category 3 CSP. An aqueous multiple-dose CSP must pass antimicrobial effectiveness testing per USP 51 Antimicrobial Effectiveness Testing (AET) standards. After a multiple-dose CSP (aqueous or nonaqueous) is dispensed and upon initially entering or puncturing the container on first use, the preparation’s BUD is 28 days or less.

BEYOND-USE DATES (BUDS)

We do not list specific BUDs on our sterile formulations due to several parameters for consideration when establishing BUDs. As a guide, we include the following Note on all PCCA sterile formulations:

Note: USP Chapter 797 sets forth parameters to consider when establishing BUDs, stating, “BUDs for CSPs should be established conservatively to ensure that the drug maintains its required characteristics (i.e., stability and sterility) until its BUD.” According to USP Chapter 797, “BUDs for CSPs must be established in accordance with Table 12 for Category 1 CSPs, Table 13 for Category 2 CSPs and Table 14 for Category 3 CSPs. One day is equivalent to 24 hours. The BUD limits in these tables are based on the risk of microbial contamination or not achieving and maintaining sterility despite implementation of the requirements in this Chapter. The CSP formulation must remain chemically and physically stable, and its packaging must maintain its integrity for the duration of the BUD.”

Extending the BUD of a sterile preparation per current USP Chapter 797 requires sterility testing for each batch in compliance with USP Chapter 71, including method suitability. Alternative sterility testing methods may be used per USP 797 if they are verified to be at least as effective and reliable as those described in USP 71. Other necessary data may include published or unpublished stability studies utilizing stability-indicating methods, endotoxin testing, container-closure integrity, antimicrobial effectiveness testing (where relevant), potency testing after compounding, as well as other relevant release checks, testing and documentation.

Members with clinical services access may contact our Clinical Services team for help with compounding sterile and non-sterile formulations in compliance with USP Chapters 795 and 797, as well as other compounding concerns.

Versions of this Blog originally appeared in PCCA’s members-only magazine, the Apothagram, as well as in separate Blog posts.

USP Chapter 797-Related Changes to Formulations

Wed, 30 Aug 2023 14:44:57 GMT

by Melissa Merrell Rhoads, PharmD, PCCA Director of Formulations

The revised USP Chapter 797 becomes official on November 1, 2023. USP 797 describes the minimum standards to follow for the preparation of compounded sterile preparations (CSPs) for human and animal drugs. If adopted by your state board of pharmacy, the requirements of USP 797 must be met to ensure the sterility of CSPs, which include but are not limited to injections, irrigations (for internal body cavities), ophthalmics and inhalations.

Changes that will occur in the PCCA sterile formulas related to USP 797 revisions are primarily seen in updates to the compounding procedures and notes.

Sterilization and depyrogenation procedures are described in Section 10 of USP 797, which states, “The sterilization method used must sterilize the CSP without degrading its physical and chemical stability or the packaging integrity. The primary means of sterilizing compounded preparations are: terminal sterilization, which includes dry heat or autoclave, and filtration.”

We will be updating the specific compounding sterilization process to comply with the revisions to USP 797. Note that one of the biggest differences is the requirement to pre-filter solutions through a 1.2-micron filter to remove potential particulate matter prior to sterilizing the preparation through autoclave or dry heat.

Filtration

Sterilization Procedure for Aqueous Solutions

Filter the solution through a sterile and depyrogenated filter (appropriate for pharmaceutical use) with a nominal pore size of 0.22 micron or smaller into an appropriate sterilized and depyrogenated container-closure system. According to USP guidelines, a bubble point test must be performed on the used filter to ensure integrity of that filter. Refer to product specifications for the required minimum pressure.

Sterilization Procedure for Oil or Alcohol Solutions

Filter the solution through a sterile and depyrogenated Teflon® filter (appropriate for pharmaceutical use) with a nominal pore size of 0.2 micron or smaller into an appropriate sterilized and depyrogenated container-closure system. According to USP guidelines, a bubble point test must be performed on the used filter to ensure integrity of that filter. Refer to product specifications for the required minimum pressure.

Autoclave

Sterilization Procedure for Solutions

Filter the solution through a sterile and depyrogenated filter (appropriate for pharmaceutical use) with a nominal pore size of not larger than 1.2 micron for removal of potential particulate matter into an appropriate sterilized and depyrogenated container-closure system.

Crimp and seal the serum bottle. Autoclave the preparation until the contents within the vial have reached 121°C, 15 psi for the length of time necessary to render the preparation sterile.

The duration of this process can vary between 20 to 60 minutes, depending on preparation volume and load configuration. This process must be verified and documented with each sterilization run or load through the use of Sterilization Integrators, Steam and SporeView® Steam Biological Indicators per USP guidelines. Refer to USP 1229, Sterilization of Compendial Articles, for more information.

Sterilization Procedure for Suspensions

Dry Heat/Convection

Sterilization Procedure for Solutions

The duration of time for this process can vary and will depend upon preparation volume and load configuration. This process must be verified and documented with each sterilization run or load through the use of SporeView® Culture Set Biological Indicators and temperature monitoring per USP guidelines. Refer to USP 1229, Sterilization of Compendial Articles, for more information.

Remove from oven immediately and allow to cool to room temperature.

Sterilization Procedure for Suspensions

When dry-heat sterilizing compounded oil suspensions, the initial filter step is removed. After the dry-heat process, it is important to provide constant agitation while the preparation is cooling to prevent clumping of the suspension.

Multiple Dose Compounded Preparations

Revisions to USP 797 also state the requirement for preserved multiple-dose CSPs. According to USP 797, a multiple-dose CSP must be prepared as a Category 2 or Category 3 CSP. An aqueous multiple-dose CSP must additionally pass antimicrobial effectiveness testing in accordance with USP 51 Antimicrobial Effectiveness Testing (AET) standards. After a multiple-dose CSP (aqueous or nonaqueous) is dispensed and upon initially entering or puncturing the container for the first time, the beyond-use date (BUD) of the preparation becomes 28 days or less.

BUDs

We will not list specific BUDs on our sterile formulations, as there are several parameters for consideration when establishing BUDs. As a guide, we will include the following on all PCCA sterile formulations:

Note: USP Chapter 797 sets forth parameters to consider when establishing beyond-use dates (BUDs), stating, “BUDs for CSPs should be established conservatively to ensure that the drug maintains its required characteristics (i.e., stability and sterility) until its BUD.” According to USP Chapter 797, “BUDs for CSPs must be established in accordance with Table 12 for Category 1 CSPs, Table 13 for Category 2 CSPs and Table 14 for Category 3 CSPs. One day is equivalent to 24 hours. The BUD limits in these tables are based on the risk of microbial contamination or not achieving and maintaining sterility despite implementation of the requirements in this Chapter. The CSP formulation must remain chemically and physically stable, and its packaging must maintain its integrity for the duration of the BUD.”

Extending the BUD of a sterile preparation per current USP Chapter 797 requires sterility testing for each batch in compliance with USP Chapter 71, including method suitability. Alternative sterility testing methods may be used per USP 797 if they are verified to be at least as effective and reliable as those described in USP 71. Other necessary data may include published or unpublished stability studies utilizing stability-indicating methods, endotoxin testing, container-closure integrity, antimicrobial effectiveness testing (where relevant), potency testing after compounding, as well as other relevant release checks, testing and documentation. Review the requirements of your state board(s) of pharmacy with whom you are licensed. For more information, refer to current USP Chapter 797 and other relevant USP Chapters.

As a reminder, PCCA FormulaPlus™ sterile formulations comply with the requirements set forth by the revised USP 797 for extending a BUD when all applicable requirements are met. FormulaPlus extended BUDs address the chemical stability of the formulation determined by a stability-indicating assay. A passing sterility test is required prior to considering applying for this extended BUD.

PCCA members may access more information related to the revisions in USP 795 and USP 797 on PCCA Play.

For information on revisions to PCCA nonsterile formulas related to the USP 795 changes, see the Spring 2023 Apothagram Formula Spotlight column, available to PCCA members on our Members-Only Website.

Members with clinical services may also contact our Clinical Services team with any questions.

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

Modular Compounding Cleanroom 101

Wed, 18 Jan 2023 18:26:42 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services and Mike DeLisio, PCCA North American Sales Director

If you're thinking of integrating compounding services into your pharmacy, are new to compounding or are a seasoned professional who’s looking to expand, it's important to know regulatory standards are changing the compounding environment. Modular cleanrooms are a great way to implement or expand existing cleanrooms and address the ever-evolving compounding pharmacy regulations and standards.

Advantages of choosing a modular compounding cleanroom include:

Lower costs
Greater customization & flexibility
Can be built adjacent to existing walls within pharmacy lab
Shorter build time
Easier to clean and maintain pressure
Reduces risk of insanitary conditions related to appropriate materials of construction
Less “down” time
Easier to supply air and exhaust air if required
Fewer disruptions for pharmacy & customers

What is a modular cleanroom?

Generally speaking, a modular cleanroom provides a dedicated space for compounding medicines within an enclosed environment. Its purpose is to help prevent compounded medications from potential contaminants and protect compounders from potentially harmful chemicals (hazardous materials) when appropriate controls are included in the design of the room. As such, a compounding cleanroom requires a well-sealed area using non-porous, powder coated materials that won’t harbor chemicals or microbes.

Modular cleanrooms are built using prefabricated materials. Given the increased regulatory focus on maintaining sanitary conditions in cleanroom environments, materials used in prefabricated constructions must be able to sustain routine exposure to harsh cleaning, sanitizing, decontaminating, or sporicidal solutions, which can easily degrade walls, doors, ceilings, and floors when they are not made from suitable materials.

Careful consideration should also be given to the cleanroom’s design, which directly impacts staff efficiency and efficacy of meeting cleaning standards. For example, walls, floors and ceilings designed with rounded or coved corners are much easier to clean than those with angular corners. Ceilings designed with a T-grid system with removable vinyl coated panels are easily sanitized and help safeguard against hidden microbes and other potential contaminants.

The type of compounding performed by your pharmacy will determine the types and levels of controls needed in the cleanroom:

A cleanroom used to compound non-sterile preparations (CNSP, USP 795) require the fewest controls;
A cleanroom used for CNSP using hazardous materials (USP 795 + USP 800) increases controls;
A cleanroom used to compound sterile preparations (CSP, USP 797) adds significant controls;
A cleanroom used for CSP using hazardous materials (USP 797 + USP 800) need maximum controls.

Additional Considerations

On November 1, 2022, the United States Pharmacopeia (USP) published revisions to General Chapter 795, Pharmaceutical Compounding — Nonsterile Preparations (CNSPs), will be official and possibly enforceable in your state on November 1, 2023. The date also triggers potential enforcement of USP 800, which addresses CNSPs and CSPs using hazardous drugs.

USP 795 revisions define minimum schedules for cleaning and sanitizing nonsterile compounding area surfaces. Cleaning and sanitizing procedures also changed in Chapter 797 revisions, including environmental monitoring and cleaning processes for specific categories of compounded sterile preparations. The FDA also focuses on the quality of the compounding environment for both CNSPs and CSPs in their guidance, Insanitary Conditions at Compounding Facilities .

Cleanroom Providers

Given regulatory oversight and complexities, it’s vital to partner with an experienced and reputable cleanroom provider with:

Knowledge of regulatory & compounding industry standards
Recommendations to improve pharmacy workflow & minimize patient inconvenience
Experience in modular compound cleanroom installation for type(s) of compounding
Guidance and support throughout the build process
1. Immediate notification of delays in cleanroom construction materials or build time
2. Previous customer experience (i.e., testimonials, peer organizations, peer collaboration)
3. Foremen and installation crews familiar with all wall-system components & trained from A to Z to install modular compounding cleanrooms

Initial Steps

Decide type(s) of compounding service(s) your pharmacy will offer (including lab expansion)
Become familiar with USP Minimum Standards
1. USP 795 sets minimum standards for non-sterile compounded preparations
2. USP 797 sets minimum standards for sterile compounded preparations
3. USP 800 sets minimum standards for compounding preparations with hazardous materials
Contact your state board of pharmacy to learn state board requirements
Become familiar with FDA guidance

Helpful Resources

PCCA partnered with ISO 9001 certified Nicos to deliver seamless cleanroom design with expert support that exceed USP minimum standards. Learn more here.

Look for our forthcoming four-part Blog series on USP 795, 797 and 800 Revisions & Impacts, scheduled to begin February 13.

For those looking for USP implementation training, we partnered with the Alliance for Pharmacy Compounding (APC) to provide courses on quality, compliance and regulatory requirements.

PCCA offers additional resources to our members, including eLearning Compounding Training and multiple online webinars and training sessions . Members with Clinical Services may also contact our Clinical Services team for help with formulas and other compounding concerns.

THE PCCA BLOG

Partnerships Between 503A Pharmacies and 503B Outsourcing Facilities

Key Differences

Wholesale Prohibitions for 503B

Evaluation Criteria for 503B Partnership

References

USP Chapters 795- and 797-Related Changes to PCCA Formulations

USP Chapters 795- and 797-Related Changes to PCCA Formulations

USP Chapter 795

Non-preserved aqueous (PF) – 14 days refrigerated

Preserved aqueous – 35 days

Nonaqueous (anhydrous) oral liquid – 90 days

Nonaqueous (anhydrous) excluding nonaqueous oral liquids – 180 days

Establishing and extending BUD

USP Chapter 797

FILTRATION

Sterilization Procedure for Aqueous Solutions

Sterilization Procedure for Oil or Alcohol Solutions

AUTOCLAVE

Sterilization Procedure for Solutions

Sterilization Procedure for Suspensions

DRY HEAT/CONVECTION

Sterilization Procedure for Solutions

Sterilization Procedure for Suspensions

MULTIPLE DOSE COMPOUNDED PREPARATIONS

BEYOND-USE DATES (BUDS)

USP Chapter 797-Related Changes to Formulations

Filtration

Sterilization Procedure for Aqueous Solutions

Sterilization Procedure for Oil or Alcohol Solutions

Autoclave

Sterilization Procedure for Solutions

Sterilization Procedure for Suspensions

Dry Heat/Convection

Sterilization Procedure for Solutions

Sterilization Procedure for Suspensions

Multiple Dose Compounded Preparations

BUDs

Modular Compounding Cleanroom 101

What is a modular cleanroom?

Additional Considerations

Cleanroom Providers

Initial Steps

Helpful Resources

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