nhia logo

Quick Links
Search NHIA.org

Sterile Compounding Resource Center

Welcome to NHIA's clearinghouse for information related to the compounding of sterile products.

The preparation of compounded sterile products (CSPs) in compliance with federal, state and industry standards is a core function of home infusion pharmacy practice.   Patients rely on the expertise of home infusion providers to ensure medications are prepared in a sterile, accurate and safe manner.  Home infusion providers must be informed of changing standards and regulations related to the professional practice of sterile compounding in order to remain in good standing with regulating bodies, and to ensure operating procedures are adequate to protect patients and employees.  NHIA strives to ensure all stakeholders are informed of the latest trends in sterile compounding regulatory and standard setting activities and regularly posts updated information on this site.

 

Oversight of Sterile Compounding

Oversight for sterile compounding practice falls primarily to the states and is typically governed by the individual state's Board of Pharmacy, however the Food and Drug Administration (FDA) also maintains authority to inspect pharmacies for insanitary conditions. In some states, the Board of Medicine (or similar entity) regulates sterile compounding that occurs in physician offices.  Additionally, most pharmacies maintain active accreditation from an agency that performs rigorous inspections for compliance with state laws and internal policies.   The majority of state laws and accreditation standards are based on the principles outlined in the U.S. Pharmacopeial Chapter <797> Pharmaceutical Compounding – Sterile Preparations.

 

Additional Resources:

Interactive Map for State Boards of Pharmacy sterile compounding rules and regulations.

U.S. Pharmacopeial Convention

  • Proposed Revision USP Chapter <797> Pharmaceutical Compounding – Sterile Preparations (download)

FDA Sterile Compounding Regulatory and Policy Information

Accreditation Resources membersonly

Hazardous Drug Compounding membersonly

 

Recent News:

(January 2017)
FDA Finalizes Repackaging Rules for Pharmacies and Outsourcing Facilities

On January 11, 2017, the U.S. Food and Drug Administration (FDA) released a final guidance entitled "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities." This final guidance addresses the definition of repackaging, the conditions under which repackaging of drug products may occur, BUD requirements, and labeling of repackaged drug products prepared by outsourcing facilities. Read the full guidance document.

*FDA's guidance documents do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

 

(January 2017)
FDA Issues Revised Draft Guidance for Mixing, Diluting and Repackaging of Biologics Products Outside the Scope of an Approved BLA

On January 11, 2017, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled "Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application." This draft guidance addresses the conditions for mixing, diluting and repackaging of biologic products; including BUD requirements and labeling of products prepared by outsourcing facilities.  Additionally, guidance is issued regarding how allergenic extracts used for subcutaneous immunotherapy must be handled.  Read the full guidance document

Action Alert:  The FDA is accepting comments on the above revised draft guidance.  Submit comments on the above guidance to Connie Sullivan, R.Ph. at connie.sullivan@nhia.org.

 

(January 2017)
FDA Issues a Status Report on the Regulation of Compounding Pharmacies, Three Years after the Passage of the Drug Quality and Securities Act.

Read the report

 

(December 2016)
FDA Finalizes Prescription Requirement for 503A Pharmacies

On December 29, 2016, the U.S. Food and Drug Administration (FDA) released a final guidance entitled "Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance sets forth FDA's policy concerning prescription requirements for compounding human drug products for identified individual patients under section 503A of the FD&C Act.  It addresses compounding before and after the receipt of a prescription for an identified individual patient as well as compounding for office use. Read the full guidance document.

*FDA's guidance documents do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

 

(July 13, 2016)
FDA Outlines New Protocols for Assessing 503A vs 503B Prior to Inspection

Notice of change in FDA procedures effective as of August 1, 2016, to assess whether a pharmacy qualifies for a 503A exemption prior to conducting an inspection for insanitary conditions. 

 

(June 6, 2016)
Final Guidance Issued by the FDA on the Interim Policy on Compounding Using Bulk Substances Under Section 503A of the Federal Food, Drug and Cosmetic Act

Describes the FDA's interim regulatory policy for licensed pharmacists and physicians regarding the use of bulk drug substances while the official list of approved bulk substances for use in compounding is being developed by the FDA.

 

(April 15, 2016)
New FDA Draft Guidance for Prescription Requirement Under Section 503A of the Federal Food, Drug and Cosmetic Act

Issued to establish prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act. It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use (or "office stock").

Read NHIA's comments to this Guidance here.

 

(April 15, 2016)
New Draft Guidance on Hospital and Health System Compounding Under the Federal Food, Drug and Cosmetic Act

Issued to describe the circumstances under which a hospital or health system should register as a 503B outsourcing facility.

 

(February 1, 2016)
New Chapter <800> Hazardous Drugs – Handling in Healthcare Settings Released by the U.S. Pharmacopeial Convention

General Chapter <800> was published on February 1, 2016 in the First Supplement to USP 39–NF 34.  The Expert Committee approved a delayed official implementation date of July 1, 2018 to allow entities additional time to implement the standard.  For more information and resources related to hazardous drug compounding, click on the link above under "Additional Resources."

 

(September 25, 2015)
Proposed Revision to U.S. Pharmacopeial Convention General Chapter <797> Pharmaceutical Compounding – Sterile Preparations Released for Review and Comment

The existing General Chapter (approved in 2008) has undergone significant review and revision to incorporate changes in industry practice.   The expert panel is currently reviewing comments submitted from stakeholders.  At this time, the current standard remains in effect until a final approved revision is released. 

Major revisions of the General Chapter include:

  1. Reorganization of existing sections and placement of procedural information in boxes
  2. Collapsing of the three compounded sterile preparation (CSP) microbial risk categories (e.g. low-, medium-, and high-risk) into two categories (Category 1 and 2) distinguished primarily by the conditions under which they are made and the time within which they are used.
  3. Removal of information on handling hazardous drugs and added cross-references to <800> Hazardous Drugs—Handling in Healthcare Settings
  4. Introduction of the terminology "in-use time" to refer to the time before which a conventionally manufactured product used to make a CSP must be used after it has been opened or punctured, or a CSP must be used after it has been opened or punctured.

Click here to download a copy of the proposed revision.

  • Click here to read NHIA's comments on the proposed revision.