For those of us that have been around a while and are well versed in the FDA’s expectations on repackaging of solid oral dosage forms into unit dose (UD) packaging, there is really nothing new in the recently published Guidance for Industry – Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products. (see full guidance here).
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 advice about the Agency’s efforts to develop a list of drugs that present demonstrable difficulties for compounding under section 503A of the FD&C Act (version in effect in 2000).
The question of where, when, and how to label a product, whether it be a prescription drug, OTC product under an approved application, or an OTC product marketed under the monograph system has always been kind of a guessing game for manufacturers, packagers, and repackagers. Now, a new Guidance titled “Child-Resistant Packaging Statements in Drug Product Labeling” answers many of those questions and provides guidance as to how to be in compliance with the FDA regulatory scheme.
FDA was hoping to have the User Fee Bill passed and to begin work on publishing fees and the accompanying Federal Register Notices that must go out ahead of the September 30 expiration of the funding measures. Remember, FDA must have legislation in place in order to request the fees, collect the fees, and spend the new money that comes in for the fees.
The controversial rule that would “amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license application (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change” has shifted to long-term actions on the HHS unified agenda (here).
On Tuesday July 18, 2017, the FDA held a public meeting entitled, “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access”. The meeting’s purpose was “intended to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.”
While there were a number of presentations which can be accessed through the CDER web site once the transcript is published (see here) the themes of each presentation were very similar.
The USP is planning to revise their USP<1058> Analytical Instrument Qualification Chapter, August 01, 2017. The planned principal changes to USP<1058> are as follows:
- The revised USP chapter introduces the concept of a user-driven risk assessment to establish the level of integrated instrument qualification to demonstrate “fitness for purpose” of the instrument.
On Thursday as I was giving a talk to a firm about the abuse-deterrent drug landscape and potential for the future, the firm that makes and markets Opana ER was announcing that it was agreeing to remove its product from the marketplace in accord with the FDA recommendations.
During the presentation, I was asked by one participant what I thought the maker of Opana ER would do.
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 and alludes that the current Act Drug Safety and Security Act of 2014 (DQSA) may deny patient access to compounded drugs.
FDA Issued a guidance document titled “Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy” (here) late last week that described the FDA’s position on enforcement discretion of certain key provisions of the Act that were set to take effect on November 27, 2017 relative to inclusion of product identifiers The guidance explains what a product identifier is and how enforcement discretion will be applied.
Appearing in today’s pre-publication of the Federal Register (here), the FDA announced the issuance of an Emergency Use Authorization (EUA) for an atropine autoinjector that has not been FDA approved to date. An EUA is issued by the FDA once a series of requests have been made and cleared for a product for a potential domestic disaster,
While I have never been a big fan of dietary supplements, far be it for me to criticize the entire dietary supplement industry. Clearly there are people that have clinically documented vitamin deficiencies and require supplementation as a result. There are also certain disease states where dietary supplementation is definitively indicated. And, like those of us who rush out to get a Vitamin C supplement at the first sign of a cold (including myself),
In a recent blog post, FDA Commissioner Scott Gottlieb reinforced FDA’s plans for supporting the growing innovation in medical technology. Dr. Gottlieb reemphasized the support for digital medical technologies through the implementation of the 21st Century Cures Act, which requires FDA to clearly define those technologies that are used for the promotion of health life choices and generally exempt from,
In what (I believe) is only the second opioid that FDA is seeking to remove from the market because the risk no longer outweighs the benefits of the product (first was the original formulation of Oxycontin), the Agency said “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks.
After slogging through some of the FDA dashboards, I came across one that I felt was worthy of mention. The FDA’s Office of Regulatory Affairs (ORA) has apparently begun the process of scoring drug manufacturing establishments in their risk-based inspection program. The FDA has been talking about risk-based inspection (as well as risk-based review) ever since I was at the Agency,