Acetaminophen Back in the Spotlight, with Draft Guidance for Pediatric Liquid Products

With the FDA’s move to reduce the amount of acetaminophen (APAP) for prescription combination products to no more than 325mg per dosage unit completed, FDA seems to be moving into the Over-the-Counter (OTC) arena to help reduce potential overdose or medication errors with liquid APAP products targeted for pediatric patients. Today, FDA released the draft Guidance Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen.

PQRI Presentation Provides Interesting Insights

In a September 17, 2014 presentation at the FDA/PQRI Conference on Evolving Product Quality given by Susan Rosencrance, Ph.D., Acting Deputy Director, Generic Drug Chemistry in the Office of Pharmaceutical Science at CDER, a number of interesting issues were presented and discussed. Some of these issues may be a welcome sign to the industry of a turnaround at OGD, but others still need some explaining.

Follow-up on Visible Particulate Matter in Parenteral Products

In a blog post on August 12, 2014, I raised the question of why there have been so many recalls of parenteral products related to visible particulate matter. There are a multitude of factors that lead to the formation of particulate matter, some of which have to do with formulation, some with storage, some with handling, some with manufacturing equipment and the like as was discussed in the blog referenced above.

Particulate Matter in Parenteral Products – Why So Much?

Last week while waiting for my flight home at an airport on the east coast, I decided to look at the recalls listed on the CDER web page. I realize that I have read about a number of recalls of parenteral products recently and those recalls were for a number of different firms, but what caught my attention was that 12 of 25 recalls listed were for visible particulate matter (including glass particles).
While I am not a manufacturing expert by any stretch of the imagination, I started to wonder why this might be.

Compounding Back in the News as FDA Adds 25 Drugs to the Do Not Compound List

The FDA is proposing to update its list of drug products (previously found in its regulations at 21 CFR 216.24) that have been removed from the market for safety or efficacy and cannot be legally compounded. It has also revised one product relative to its dosage form that allows compounding under the pharmacy compounding exemption. Since FDA has approved an ophthalmic form of bromfenac, it has removed the restriction to now permit the compounding in certain situations for this drug product but only for ophthalmic use, whereas this drug was previously excluded for any use by the Rule.

New Requirements on FDA Notification of Suspected Illegitimate Products To Begin January 1, 2015

FDA issued a Draft Guidance, entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification which describes the proper means of notification of FDA by trading partners of the potential suspect products. The requirements under the Drug Supply Chain Security Act (DSCSA) will kick in on January 1, 2015 and also requires firms to identify other immediate trading partners of their suspicion. The Guidance defines trading partners as manufacturers, repackagers, wholesalers or dispensers and requires the notice to be given to FDA within 24 hours of identifying a suspect product.

Use of Animal Rule Discussed in Revised FDA Guidance

FDA typically requires safety and efficacy to be demonstrated in humans, but there are times when exposure of humans to toxic therapeutic substances may be impractical and ethically impossible (e.g., antidote for nerve gas treatment, nuclear threat, biological, chemical or substance that would otherwise causea life-threating condition or poisoning [e.g., snake venom, virus, industrial chemicals]). The FDA has released a newly revised update to its previously issued 2009 Guidance on this topic.

Buyer Beware! That Legitimate Looking Prescription Site May Cost You Your Health

In a coordinated enforcement action involving the FDA, US Customs and Border Patrol, along with international agencies like Interpol and enforcement and regulatory bodies from 111 countries, action was taken against web sites that “sell unapproved prescription drugs to US consumers.” This is part of an ongoing effort of a program termed Operation Pangea.

FDA Acts to Prevent a Shortage Situation for an Emergency Drug

On May 13, 2014, the FDA took the third in an unusual series of evaluations to extend the expiration date of certain lots of the drug DuoDote Autoinjectors (atropine and pralidoxine chloride), a drug indicated for the initial treatment of poisoning by organophosphorous nerve agents and insecticides. The manufacturer of the drug product notified FDA of problems relative to under-dosing or failure to activate associated with a small number of its autoinjectors. The FDA responded with a letter (here) indicating that the Agency would exercise enforcement discretion and would, based on information provided by the firm, extend the expiration date for one year beyond the current established expiration date. FDA also noted that the firm would not need to revise the expiration date on the actual packaging.