News
ICViewExpert PerspectivesMedical World NewsPathogen PlaybookVideosWebinars
Conference CoverageConference ListingAPIC Chapters
Infection Control TodaySupplements And Featured Publications
CME/CEEditorial Advisory BoardJob BoardPartnersSponsoredWhitepapers
Subscribe
Educator of the Year Official Rules2025 Educator of the Year Winner2024 Educator of the Year Winner2023 Educator of the Year WinnerEducator of the Year
Advanced TechnologyAdvanced TechnologyAdvanced Technology
Bug of the Month
COVID-19
Environmental ServicesEnvironmental Services
HAIs
Hand Hygiene
IC Trends
Long-Term CareLong-Term Care
Operating Room
Personal Protective EquipmentPersonal Protective Equipment
Policy
PreventionPreventionPreventionPrevention
Sterile ProcessingSterile Processing
Surface Disinfection
Vascular Access
Spotlight -
  • IC Trends
  • Bug of the Month
  • Featured Articles
  • Featured Columns
  • Pathogen Playbook
Advanced TechnologyAdvanced TechnologyAdvanced Technology
Bug of the Month
COVID-19
Environmental ServicesEnvironmental Services
HAIs
Hand Hygiene
IC Trends
Long-Term CareLong-Term Care
Operating Room
Personal Protective EquipmentPersonal Protective Equipment
Policy
PreventionPreventionPreventionPrevention
Sterile ProcessingSterile Processing
Surface Disinfection
Vascular Access
    • News
    • Subscribe
Advertisement

FDA Issues New Draft Documents Related to Compounding of Human Drugs

February 16, 2015
Article

Today, the Food and Drug Administration (FDA) issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.

The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products. Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use. Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.

Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the FD&C Act, or they will be subject to all of the requirements applicable to drugs produced by conventional drug manufacturers.

“The draft guidance documents provide information to pharmacies, outsourcing facilities, health care entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” says Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

The documents are:

Draft Guidance: For Entities Considering Whether to Register As Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act
The draft guidance provides an entity considering whether to register with the FDA as an outsourcing facility under the law with information about the regulatory impact of registering. For example, it explains that a facility engaged in only certain activities, including repackaging human drugs and compounding non-sterile drugs, should not register as an outsourcing facility because its drug products will not qualify for the exemptions provided in section 503B, including the exemption from the new drug approval requirements.

Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
The draft guidance describes the conditions under which the FDA does not intend to take action for certain violations of the law when state-licensed pharmacies, federal facilities or outsourcing facilities repackage certain drug products. Repackaging generally involves taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container. Repackaged drug products are generally not exempt from any of the provisions of the FD&C Act related to the production of drugs, and the compounding provisions of the FD&C Act do not address repackaging. Therefore, the FDA is issuing guidance to describe how it intends to address repackaging when done in a state-licensed pharmacy, federal facility, or outsourcing facility.

Draft Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (BLA)
The draft guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act (PHS Act) and the FD&C Act when state-licensed pharmacies, federal facilities or outsourcing facilities mix, dilute or repackage specific biological products without an approved BLA, or when such facilities or physicians prepare prescription sets of allergenic extracts (used to treat allergies) without an approved BLA. The draft guidance notes that a biological product that is mixed, diluted or repackaged outside the scope of an approved BLA is an unlicensed biological product under section 351 of the PHS Act and may not be legally marketed without an approved BLA. Additionally, the compounding provisions of the FD&C Act do not address biological products subject to licensure under section 351 of the PHS Act. Therefore, the FDA is issuing guidance to describe how it intends to address these practices.

Draft Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act
Entities registered as outsourcing facilities are required to report adverse events to the FDA. The draft guidance explains adverse event reporting for outsourcing facilities.

Draft Memorandum of Understanding Between A State and the U.S. Food and Drug Administration Addressing Certain Distributions of Compounded Human Drug Products
The draft MOU under section 503A of the FD&C Act describes the responsibilities of a state that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the state, and in addressing the interstate distribution of “inordinate amounts” of compounded human drug products.

These documents are the latest in a series of policy documents related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities and outsourcing facilities.

The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA.

Source: FDA

Newsletter

Stay prepared and protected with Infection Control Today's newsletter, delivering essential updates, best practices, and expert insights for infection preventionists.

Subscribe Now!
Recent Videos
 Brenna Doran PhD, MA, hospital epidemiology and infection prevention for the University of California, San Francisco, and a coach and consultant of infection prevention; Jessica Swain, MBA, MLT, director of infection prevention and control for Dartmouth Health in Lebanon, New Hampshire; and Shanina Knighton, associate professor at Case Western Reserve University School of Nursing and senior nurse scientist at MetroHealth System in Cleveland, Ohio
 Brenna Doran PhD, MA, hospital epidemiology and infection prevention for the University of California, San Francisco, and a coach and consultant of infection prevention; Jessica Swain, MBA, MLT, director of infection prevention and control for Dartmouth Health in Lebanon, New Hampshire; and Shanina Knighton, associate professor at Case Western Reserve University School of Nursing and senior nurse scientist at MetroHealth System in Cleveland, Ohio
In a recent discussion with Infection Control Today® (ICT®), study authors Brenna Doran PhD, MA, hospital epidemiology and infection prevention for the University of California, San Francisco, and a coach and consultant of infection prevention; Jessica Swain, MBA, MLT, director of infection prevention and control for Dartmouth Health in Lebanon, New Hampshire; and Shanina Knighton, associate professor at Case Western Reserve University School of Nursing and senior nurse scientist at MetroHealth System in Cleveland, Ohio, shared their insights on how the project evolved and what the findings mean for the future.
Related Content

CDC  (Adobe Stock unknown)

CDC Firings: Wake up, America, Public Health Needs You

Heather Stoltzfus, MPH, RN, CIC
August 31st 2025
Article

Pill bottle with assorted antibiotics and vitamins spilling out   (Adobe Stock 1485283959 by Jiran)

Fuel Immunity First: How to Use Nutrition to Stay Ahead of Infection

Tori Whitacre Martonicz
August 31st 2025
Podcast

Classroom  (Adobe Stock unknown)

Back-to-School: An Infection Preventionist’s Guide to a Healthier School Year

Heather Stoltzfus, MPH, RN, CIC
August 31st 2025
Article

Set of bright yellow sharps containers with biohazard labels and red lids used in clinics and hospitals for safe disposal of medical needles and waste.    (Adobe Stock 1521632893 by Maksim)

Sharps Safety Starts with Us: Why Infection Preventionists Must Lead the Charge

Tori Whitacre Martonicz
August 31st 2025
Podcast

Infection Control Today® Educator of the YearTM Official Rules

Infection Control Today's Educator of the Year Award Official Rules

August 31st 2025
Article

A health care professional's gloved hands meticulously clean and sterilize a surgical instrument with a green sterile cloth.  (Adobe Stock 1557328533 by Alina)

Implementing Point-of-Use Instrument Care to Mitigate Surgical Site Infections in Operating Rooms

Anthony Onunga, MBChB
August 31st 2025
Article
Related Content

CDC  (Adobe Stock unknown)

CDC Firings: Wake up, America, Public Health Needs You

Heather Stoltzfus, MPH, RN, CIC
August 31st 2025
Article

Pill bottle with assorted antibiotics and vitamins spilling out   (Adobe Stock 1485283959 by Jiran)

Fuel Immunity First: How to Use Nutrition to Stay Ahead of Infection

Tori Whitacre Martonicz
August 31st 2025
Podcast

Classroom  (Adobe Stock unknown)

Back-to-School: An Infection Preventionist’s Guide to a Healthier School Year

Heather Stoltzfus, MPH, RN, CIC
August 31st 2025
Article

Set of bright yellow sharps containers with biohazard labels and red lids used in clinics and hospitals for safe disposal of medical needles and waste.    (Adobe Stock 1521632893 by Maksim)

Sharps Safety Starts with Us: Why Infection Preventionists Must Lead the Charge

Tori Whitacre Martonicz
August 31st 2025
Podcast

Infection Control Today® Educator of the YearTM Official Rules

Infection Control Today's Educator of the Year Award Official Rules

August 31st 2025
Article

A health care professional's gloved hands meticulously clean and sterilize a surgical instrument with a green sterile cloth.  (Adobe Stock 1557328533 by Alina)

Implementing Point-of-Use Instrument Care to Mitigate Surgical Site Infections in Operating Rooms

Anthony Onunga, MBChB
August 31st 2025
Article
Advertise
About Us
Editorial Board
Contact Us
Job Board
Terms and Conditions
Privacy
Do Not Sell My Personal Information
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.
Home
About Us
News