News & Analysis as of

Drug Compounding Draft Guidance

Quarles & Brady LLP

FDA Releases Draft Interim Guidance on Bulk Drug Substances in Compounding Under Sections 503A and 503B of FDCA

Quarles & Brady LLP on

The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more

BakerHostetler

FDA Clarifies Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act

BakerHostetler on

On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more

BakerHostetler

FDA Provides Playbook for Developing Cannabis Drugs

BakerHostetler on

The U.S. Food and Drug Administration (FDA) recently released the Draft Guidance for Industry, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. In this guidance, the FDA defers to the...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

Holland & Knight LLP

FDA Issues Draft Guidance on Bulk Substances for Compounding by Outsourcing Facilities

Holland & Knight LLP on

On March 23, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance regarding the process through which it proposes to evaluate bulk drug substances nominated for use in compounding by outsourcing...more

Robinson+Cole Health Law Diagnosis

FDA’s New Draft Guidance on Bulk Drug Substances in Compounding

This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...more

Arnall Golden Gregory LLP

FDA Releases Draft Guidances on Compounded Drugs, Helps to Answer “When are they Copies?”

Some of us remember the television commercial and poster, created by the then-audio cassette company, Memorex, asking “is it live, or is it Memorex?” Forty years later, the Food and Drug Administration could paraphrase the...more

King & Spalding

FDA Issues Three Draft Guidance Documents For Drug Compounders

King & Spalding on

On April 15, 2016, the U.S. Food and Drug Administration (“FDA”) issued three new draft guidance documents related to human drug compounding under the Food, Drug, and Cosmetic Act (“FD&C Act”), as amended by Title I of the...more

Akin Gump Strauss Hauer & Feld LLP

FDA Issues Guidance for Hospitals and Health Systems Engaged in Drug Compounding

If you read one thing... - FDA interprets the FDCA not to permit compounding for “office use” under Section 503A; compounding pharmacies must receive a valid prescription for an individually identified patient before...more

BakerHostetler

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more

McGuireWoods LLP

Animal Compounding Guidance (Draft) for Use of Bulk Drug Substances Released by FDA Today

McGuireWoods LLP on

On May 18, 2015, FDA released new draft guidance on animal drug compounding from bulk drug substances. While FDA’s current statutory framework and regulations do not permit compounding of animal drugs from bulk drug...more

Akin Gump Strauss Hauer & Feld LLP

FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

BakerHostetler

Now's the Time to Comment on the FDA's New Draft Documents on Compounding Policy

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has released five new draft documents related to drug compounding and repackaging by “outsourcing facilities,” state-licensed pharmacies, federal facilities and other healthcare...more

Akin Gump Strauss Hauer & Feld LLP

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

Cooley LLP

FDA Releases Five New Compounding Pharmacy Policy Documents

Cooley LLP on

Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use. All of the documents are available through the FDA’s...more

15 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide