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FDA issued a Draft Guidance, entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification which describes the proper means of notification of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.

Confused About the Force of FDA Draft Guidance? You Are in Good Company!

The issue of when to apply FDA Draft Guidance has always been a bit confusing and sometimes an amusing subject. FDA Guidance (whether in draft or final form) is supposed to represent the FDA’s current thinking on a specific matter. If the Draft Guidance is newly issued and is still within a reasonable comment period, then it may be best to contact FDA to see if the Guidance is likely to change. Sometimes you can look at the comments submitted to the appropriate Docket to see if there appears to be controversial issues raised by the industry or other government components. The real problem comes when a Draft Guidance is issued and the comment period has passed and months or years go by where the Guidance just sits there in limbo before being finalized.

To Register or Not to Register – Compounding Pharmacy Dilemma

For Compounding Pharmacies, there is a new law (Compounding Quality Act) and a sheriff (the FDA) to enforce the law. The new law is an amendment to the Food, Drug & Cosmetic Act (FDCA), which (amongst other things) requires that the drugs must be compounded in compliance with Current Good Manufacturing Practices (CGMP) by or under direct supervision of a licensed pharmacist in a registered facility.

Under this new law, some compounding pharmacies will be categorized as “outsourcing facilities”. Those pharmacies that compound sterile drugs, among others, must register with the FDA as an “outsourcing facility”.

37 Compounding Pharmacies Currently Registered as Outsourcing Facilities

As of April 11, 2014, the FDA has received and processed requests for 37 compounding pharmacies as outsourcing facilities. In October 2014, outsourcing facilities will be required to pay a fee. The fee schedule will be published in August 2014, and any facility that registers on or after fees are due will have to pay the registration fee at the time of registration.

MDI and Dose Counters – FDA Reaffirms Position

On April 10, 2014, FDA responded to a petition from Teva Respiratory LLC approving it in part and denying it in part. Teva requested that FDA refuse to approve any rescue inhaler (generally metered dose inhalers (MDIs) of short-acting beta agonist like albuterol), brand or generic, unless it has a dose counter, and that FDA implement a plan to transition all currently approved rescue inhalers to versions incorporating a dose counter.

Who’da Thunk?

At the outset of the generic drug scandal uncovered in the late 1980’s FDA developed an administrative Application Integrity Policy. At or about the same time, legislation (the Generic Drug Enforcement Act [GDEA] of 1992), provided for debarment of individuals convicted of certain misdemeanor or felony offenses. During the generic drug scandal, there were 22 criminal convictions of drug companies and 70 convictions of industry and FDA personnel as well as $50 million in fines levied against these organizations and individuals. Eventually there were some 70 individual debarment actions relating to the shenanigans that occurred but to date no firm has been debarred under the provisions of the GDEA. I thought it might be interesting to see what the number of debarments looked like over the last few years.

Warning Letters Continue for Compounding Pharmacies – FDA Cites Five in 2014 So Far

The FDA has stepped up its surveillance of compounding pharmacies and has issued at least 5 Warning Letters to such establishment so far this year. The beat goes on, and now the FDA must begin to integrate with the State Boards of Pharmacy and State Drug Inspectors to determine the evolving definition of what is a compounding pharmacy and what is an “outsourcing” compounding pharmacy.