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Searching Content by Rachael Pontikes from Duane Morris LLP ordered by Published Date Descending.
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1
FDA Form 483 Inspectional Observations Are Not Findings of Wrongdoing
Since shortly after the U.S. Food and Drug Administration ("FDA") began publishing FDA Form 483 inspectional observations of Section 503B outsourcing facilities, many State Boards of Pharmacy have inappropriately relied upon the FDA's findings as a basis to pursue outsourcing facilities for violations of state law.
United States
27 Oct 2016
2
FDA Solidifies Its Position On Certain Compounding Issues In New Guidance Documents
On June 9, 2016, the U.S. Food and Drug Administration published two final guidance documents on drug compounding under Sections 503A and 503B of the Food, Drug, and Cosmetic Act.
United States
21 Jun 2016
3
FDA Clarifies Its Position On Several Compounding Issues In New Draft Guidance Documents
On April 15, 2016, the U.S. Food and Drug Administration announced the release of three new draft guidance documents on drug compounding under Sections 503A and 503B of the Food, Drug, and Cosmetic Act.
United States
17 May 2016
4
FDA Publishes Revised Guidance On Product Tracing Requirements For Dispensers
On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed in the United States."
United States
5 Nov 2015
5
FDA Publishes Draft Guidance Documents On Compounding Using Bulk Drug Substances
FDA is currently developing this bulk substances list, which it will publish in the Federal Register and promulgate as a regulation pursuant to section 503A(b)(1)(A)(i)(III) of the FD&C Act.
United States
4 Nov 2015
6
FDA Issues New Documents Governing Drug Compounding
The first few months of 2015 have proven very active for the U.S. Food and Drug Administration (FDA) and its regulation of pharmaceutical compounding.
United States
8 Apr 2015
7
Drug Quality And Security Act Does Not Apply To Veterinary Compounding
While the Drug Quality and Security Act (DQSA) provided a new regulatory framework for compounded medications for use in human medicine, it does not apply to veterinary compounded medications.
United States
10 Mar 2015
8
Compounding Pharmacy Co-Owner Pleads Guilty To Misdemeanor Criminal Violations Of The Food, Drug, And Cosmetic Act
The U.S. Food and Drug Administration, acting through the U.S. Department of Justice appears to have relied on the Park Doctrine to hold a corporate officer of a compounding pharmacy criminally responsible for the pharmacy's violations of the Federal Food, Drug, and Cosmetic Act (FDCA).
United States
22 Dec 2014
9
FDA Issues Guidance On Registration, Fees And Reporting Requirements For Drug Compounding Outsourcing Facilities
On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities.
United States
9 Dec 2014
10
FDA Gives Guidance On Compounding For Human Use
The FDA released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities.
United States
15 Jul 2014
11
FDA Releases Draft Guidance On Section 503B Fees For Drug Compounding Outsourcing Facilities; Details Process For Paying And Calculating Fees
The FDA published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities.
United States
8 Apr 2014
12
Compounding Pharmacies Now Subject To Federal Oversight
On November 27, 2013, President Obama signed into law the Drug Quality and Security Act.
United States
3 Dec 2013
13
U.S. House Introduces Bill On Federal Oversight Of Compounding Pharmacies
On September 12, 2013, U.S. Representative Morgan Griffith introduced H.R. 3089 which proposes a structure for federal oversight of compounding pharmacies.
United States
20 Sep 2013
14
Senate HELP Committee Releases Revised Senate Bill Providing Federal Oversight for Compounding Pharmacies
The Senate HELP Committee has released a revised draft Senate Bill ("Revised Senate Bill"), updating the committee's first proposed compounding bill and signaling the latest push for the U.S. Food and Drug Administration's (FDA) regulation of compounding pharmacies.
United States
30 Jul 2013
15
Compounding Legislation Goes Through Another Change: New House Bill on Federal Oversight
On July 11, 2013, U.S. Representative Morgan Griffith (R-Va.) released a revised draft House Bill ("Griffith Bill"), updating the June 14, 2013, release of Senator Griffith's first proposed compounding bill, and signaling the latest push for the U.S. Food and Drug Administration's (FDA) regulation of compounding pharmacies.
United States
20 Jul 2013
16
Congress Drafts Compounding Legislation -- Defines Compounded Drugs As "New Drugs" Under The FFDCA And Creates Bright Line Between "Traditional Compounders" And "Compounding Manufacturers"
In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies.
United States
5 May 2013
17
Compounding Animal Drugs From Bulk Ingredients
A discussion relating to the federal role in regulating compounding pharmacies has focused on compounded drugs for human use.
United States
22 Apr 2013
18
FDA Emphasizes Patient-Specific Prescriptions
The FDA's reliance on the compliance policy guide as a basis for the need for a patient-specific prescription is also noteworthy.
United States
31 Mar 2013
19
FDA Tightens Requirement For Patient-Specific Prescriptions In The Wake Of The Meningitis Outbreak
In a letter to compounding pharmacy PharMEDium, the U.S. Food and Drug Administration (FDA) stated it was no longer willing to accept an alternate method of satisfying the requirement for a patient-specific prescription.
United States
4 Mar 2013
20
U.S. Government’s Use Of The "Park Doctrine" To Police Pharmacies
Based on the current public scrutiny that compounding pharmacies are under due to the outbreak of fungal meningitis in Massachusetts, pharmacy executives may want to review their internal procedures for compliance with the FDCA to ensure they are robust.
United States
8 Jan 2013
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