Pharmacy Accreditation

Ambulatory Infusion Centers are centralized locations where a patient can receive infusion therapy that is administered by the appropriate clinical personnel.

Community Retail services are provided in retail stores that sell prescription medications and commonly used durable medical equipment and supplies to the consumer.

Infusion Nursing services involve the administration of parenteral medications via various accesses and ports provided by a qualified Registered Nurse (RN), Licensed Practical Nurse (LPN), or skilled professional, as allowed by state regulations, specifically trained in these specialized services. These services can be provided in a variety of settings. A Registered Nurse or Pharmacist is responsible for supervision of all IRN services.
NOTE: IRN can be recognized for reimbursement by third-party payors and licensing boards. As of 2021, providers seeking to meet the Conditions for Coverage (CfCs) to receive Medicare reimbursement must be accredited under ACHC’s Home Infusion Therapy Accreditation program.

Infusion Pharmacy services include IV drug mixture preparation, therapy monitoring, client/patient counseling, and education. ACHC Infusion Pharmacy Standards include sterile compounding, referencing USP <797>. IRX covers the process of sterile compounding, patient care, and pharmacy-related DMEPOS equipment and supplies.

Revised ACHC IRX Standards that include USP updates to Chapter <797> took effect June 1, 2024. Organizations must now meet new USP requirements. Accreditation options offered before that date have ended.

Infusion pharmacies that handle hazardous drugs must add Hazardous Drug Handling (HD) Accreditation as a service. HD Accreditation Standards incorporate safety requirements of USP Chapter <800>. (Options offered before June 1, 2024, have ended.) The ACHC Distinction in Hazardous Drug Handling (HDH) has been retired and is no longer available.

Hazardous Drug Handling Accreditation (Ref. USP <800>)

Hazardous Drug Handling (HD) Accreditation Standards incorporate patient, employee, and environmental protection requirements established by USP General Chapter <800>, which became enforceable November 1, 2023. It is not a stand-alone service and is available for pharmacies seeking or renewing ACHC Infusion Pharmacy (IRX) Accreditation.

Infusion Pharmacy without Sterile Compounding enables infusion and specialty pharmacies to achieve accreditation without a clean room. Accreditation is available for infusion pharmacies facing delays in completing and certifying a clean room and for infusion and specialty pharmacies that supply, but don’t prepare, sterile infused medications.

IRX-NO797 includes IV administration, therapy monitoring, client/patient counseling, and education. It is the administration of medications using intravenous, subcutaneous, and epidural routes. IRX-NO797 focuses on the process of patient care and pharmacy-related DMEPOS equipment and supplies.

For more information, visit achc.org/irx-no797/.

Long-Term Care Pharmacy services include managing medications for residents of institutional facilities to ensure proper drug therapy, as well as packaging and delivery of medications.

Mail Order Pharmacies focus on the preparation and dispensing of prescription medications delivered by qualified distribution methods directly to consumers. Pharmacies that undergo this accreditation demonstrate compliance with standards addressing: Pharmacy licensure, shipping methodology, patient and employee safety, prescription intake and review, patient records and communication, personnel training, organizational oversight, and ongoing quality improvement.

Specialty Pharmacies dispense medications (injectable, intravenous, or oral) to a client’s/patient’s home, physician’s office, or clinic specializing in certain disease states. Specialty medications target a specific population with a chronic and sometimes life-threatening disease. Specialty Pharmacy services include disease-specific clinical monitoring, as well as patient compliance and adherence programs.

Specialty Pharmacy without DMEPOS services are for specialty pharmacies that DO NOT supply and/or bill Medicare patients for DMEPOS products as described by Medicare Part B coverage guidelines. This accreditation survey date can be coordinated and announced. ACHC will not report DMEPOS-accredited product codes to the National Supplier Clearinghouse (NSC).

Non-Sterile Pharmacy Compounding is a process by which ingredients are combined, mixed, or altered to create pharmaceutical preparations. These preparations are designed to be administered by a route that does not require sterility as result of a practitioner’s prescription. Compounding includes the preparation of drugs in anticipation of receiving prescriptions based on routine, regularly observed prescribing patterns. PCAB Non-Sterile Pharmacy Compounding Accreditation references USP <795> and measures a specific set of process standards that concentrate on the quality and consistency of compounded preparations.

Revised PCAB CFNS Standards that include USP updates to Chapter <795> took effect June 1, 2024. Organizations must now meet new USP requirements. Accreditation options offered before that date have ended.

Compounding pharmacies that handle hazardous drugs must add Hazardous Drug Handling PCAB (HDPCAB) Accreditation as a service. HDPCAB Accreditation Standards incorporate safety requirements of USP Chapter <800>. (Options offered before June 1, 2024, have ended.) The PCAB Distinction in Hazardous Drug Handling (HDH) has been retired and is no longer available.

Hazardous Drug Handling PCAB Accreditation (Ref. USP <800>)

HDPCAB Accreditation Standards incorporate patient, employee, and environmental protection requirements established by USP General Chapter <800>, which became enforceable November 1, 2023. It is not a stand-alone service and is available for compounding pharmacies seeking or renewing PCAB Accreditation for Non-Sterile (CFNS) Pharmacy Compounding.

Sterile Pharmacy Compounding is the practice of creating sterile preparations for patients through strict procedures to prevent contamination and maintain patient safety. PCAB Sterile Pharmacy Compounding Accreditation references USP <797> and measures a specific set of process standards that concentrate on the quality and consistency of medications that are produced.

Revised PCAB CFST Standards that include USP updates to Chapter <797> took effect June 1, 2024. Organizations must now meet new USP requirements. Accreditation options offered before that date have ended.

Compounding pharmacies that handle hazardous drugs must add Hazardous Drug Handling PCAB (HDPCAB) Accreditation as a service. HDPCAB Accreditation Standards incorporate safety requirements of USP Chapter <800>. (Options offered before June 1, 2024, have ended.) The PCAB Distinction in Hazardous Drug Handling (HDH) has been retired and is no longer available.

Hazardous Drug Handling PCAB Accreditation (Ref. USP <800>)

HDPCAB Accreditation Standards incorporate patient, employee, and environmental protection requirements established by USP General Chapter <800>, which became enforceable November 1, 2023. It is not a stand-alone service and is available for compounding pharmacies seeking or renewing PCAB Accreditation for Sterile (CFST) Pharmacy Compounding.

This additional recognition encompasses delivery of medications for the treatment of HIV; the ability to clearly manage client/patient adherence to these medications; collaboration between the physician, pharmacist, and client/patient to optimize the client’s/patient’s plan of care; cost containment; and outcomes. This distinction in HIV will show a clear, delineated dispensing and purchasing methodology.

This additional recognition was developed as a way for infusion providers to demonstrate their expertise in the delivery of parenteral and enteral nutrition products, with a focus on nutrition-specific pharmacy operations and provision of care. This distinction must be achieved in combination with ACHC Infusion Pharmacy Accreditation.

This additional accreditation recognition encompasses: delivery of medications for the treatment of cancer-specific conditions; the ability to identify the toxic nature of these medications; and collaboration between the physician, pharmacist, and client/patient to optimize the client’s/patient’s plan of care, cost containment, and client/patient outcomes.*

The additional recognition in Rare Diseases and Orphan Drugs encompasses processes and procedures necessary to bring medications for rare diseases into market from FDA approval to patient management, employee education, and medication handling and dispensing. There must be a clear, and agreed upon, collaboration between the pharmacy and the manufacturer to provide optimal patient care with the ability to collect, analyze, report on, and act upon data collected during the patient treatment journey.