Lachman Consultant Services, Inc. / Articles by: Roy Sturgeon, PhD.
11
Sep

The Devil is in the Details:  Requirements for State Boards of Pharmacy under the Draft Standard MOU Regarding 503A Compounding and Intrastate and Interstate Distribution

By    Sep 11, 2018    Compliance FDA

The FDA estimates that the burden of information collection under their newly revised draft Memorandum of Understanding (MOU) (here) and reporting to the FDA to be about 7600 hours per year per state (assuming approximately 2000 work hours per year; this equates to about four new employees per year per state).  The FDA also estimates […]

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01
Aug

Welcome to the 21st Century – FDA Goes Greener!

By    Aug 01, 2018    Compliance FDA Regulatory Affairs Science & Technology

On May 30, 2018, Diana Amador, Program Division Director, Office of Pharmaceutical Quality Operations (OPQO), Division I, issued a letter to “Our Regulated Pharmaceutical Industry”. This letter offers firms an opportunity to submit all FDA 483 responses in electronic format up to 100 megabytes. If files exceed 100 megabytes, they may be submitted as smaller […]

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27
Feb
Policy isolated on elegant green round button abstract illustration

Compounding Fairness???

By    Feb 27, 2018    Compliance FDA Generics Regulatory Affairs Science & Technology

As the compounding Industry awaits the next round of Guidances from FDA on using bulk drug substances, one point of controversy appears to be the fairness of compounding for 503A and 503B entities. The most recent Guidances for Compounding from Bulk Drug Substances are: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A […]

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30
Jan

Is There a New Tactic for Generic Manufacturers to Use to Hit a Bullseye?

By    Jan 30, 2018    Compliance FDA Generics Regulatory Affairs

We have long heard arguments that traditional and Outsourcing compounding entities represent unfair competition to the generic drug industry and that they frequently circumvent the Federal Food, Drug and Cosmetic Act (especially the 2013 Drug Quality and Security Act, DQSA). A new tactic that has been recently used by a generic firm to protect its […]

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26
Jan
FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan Image

FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan (Part II)

By    Jan 26, 2018    Compliance Generics Regulatory Affairs Science & Technology

Just days after FDA Commissioner Dr. Scott Gottlieb shared the 2018 Compounding Policy Priorities Plan, FDA issued three guidances: (1) Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act   ; (2) Compounded Drug Products That Are Essentially Copies of Approved Drug […]

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23
Jan
Bending, Breaking or Moving On Image

Thought FDA Was Tempering Back Its Oversight and Enforcement of Compounding Operations? Think Again!

By    Jan 23, 2018    Compliance FDA Regulatory Affairs

Commissioner Dr. Scott Gottlieb shared FDA’s 2018 Compounding Policy Priority Plan (here) providing an overview of the Agency’s key priorities to implement (and enforce) the federal law on compounding (Drug Quality and Security Act [DQSA], signed into law November 2013). He also states that this plan advances FDA’s mission to protect the health and safety […]

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13
Nov
FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan Image

Compounding Pharmacies Still in FDA’s Crosshairs

By    Nov 13, 2017    Compliance FDA Science & Technology

From August 2016 to October 2017, FDA has issued 63 Warning Letters (an average of 4 per month) and has orchestrated 4 Injunctions and multiple prosecutions against Compounding Pharmacies and their Principals. Most of the Warning Letters deal with citations for insanitary conditions for compounding and for lack of sterility assurance for compounded preparations. It […]

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07
Aug

Pharmacy Compounding in the News Again – Difficult to Compound List – A Long Time Coming

By    Aug 07, 2017    Compliance FDA Science & Technology

Looks like FDA is nearing the end of the daunting task of developing and (soon hopefully) publishing a “Difficult to Compound List” that has been in the works for nearly 17 years. At a meeting on July 13 and 14, 2000, an advisory committee on compounding (specifically, the Pharmacy Compounding Advisory Committee [PCAC]) provided FDA […]

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06
Jul
USP, BP, EP or JP - Which Should You Cite? - Lachman Consultants

Pharmacy Compounding in The News Again

By    Jul 06, 2017    Compliance FDA

Congress has introduced the Compounded Drug Access Bill, H.R. 2871.  This blog article only addresses the first four sections of H.R. 2871, “Preserving Patient Access to Compounded Medications Act of 2017”. Here we go again with another introduced bill for pharmacy compounding. This six-page bills title (above) purports to “preserve” patients’ access to compounded drugs […]

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23
Jan

FDA 2017 List of 101 Guidances – How Many Apply to Compounding Pharmacies and Are You Current and in Compliance???

By    Jan 23, 2017    Compliance FDA Generics Regulatory Affairs Science & Technology

For 503A and 503B compounding pharmacies, how do you protect your business from heavy-handed interventions from State and Federal Regulators? Can you affirmatively respond to the following questions? Do you know the Federal and State laws you are required to follow? Do you have the right enabling documentation (procedures, policies, records, etc., in place and […]

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