Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
July 31
Warning Letters
The following Warning Letters fall into the same violation: "Upon review of your website the claims you make establish your product as a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. Consequently, this product is classified as a dietary supplement that is adulterated."
1. Mind, Body & Coal LLC, Lisa Smith, Tampa, FL 33611
Product: Miracoal - Ultimate Hangover Relief Pills
2. Purple Biosciences, LLC, M Elias, CEO, San Diego, CA 92130
Product: Purple Tree for hangover prevention
3. LES Labs, John Heathco, CEO, Los Angeles, CA 91789
Product: DeToxx-for-Hangovers
4. Happy Hour Vitamins, Ben Shaw, President, Wilmington, NC 28401
Product: Happy Hour Vitamins
5. Ebnsol, Inc., Michal Radziszewski, CEO, San Diego, CA 92103
Product: PartyPal
6. Vita Heaven, LLC dba Hangover Heaven, J. Burke, MD President, Las Vegas NV 89109
Product: Hangover Heaven Nightlife Prep Supplement
7. Double Wood, LLC, Reese Wood, President, Philadelphia, PA 19129
Product: Dycetin ( for Hangover, Liver, and Brain protection )

Warning Letter issued jointly with the Federal Trade Commission to Vapore, LLC, dba Mypurmist for selling fraudulent COVID-19 related products.   The company sells Mypurmist with misleading claims that the product can mitigate, prevent, treat, diagnose or cure COVID-19 in people. There are currently no approved products that prevent or treat COVID-19.

The U.S. Food and Drug Administration has announced that the manufacturers of certain per- and polyfluoroalkyl substances (PFAS) have agreed to phase out these materials that have been used in food packaging. These PFAS have been used to grease proof paper and paperboard in some fast food wrappers, to go boxes, and pizza boxes in the United States.  PFAS have raised questions about potential human health risks from chronic exposure.

Guidance for Industry:  Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.  This guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for these repackaged products and appropriate expiration dates under those circumstances.  To obtain your copy paste this address into your browser: https://www.fda.gov/media/70985/download   
July 29
Companies issuing nationwide Recalls of Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and/or Subpotent Ethyl Alcohol content.
Resource Recovery & Trading LLC "Hand Sanitizer" in 200 mL and 20 Liter containers
4e Brands North America "Hand Sanitizer" unspecified sizes
Broncolin S.A. de C.V. "Herbacil Antiseptic Hand Sanitizer 70%" 125, 250, 500, & 1000 mL
Real Clean Distribuciones SA de CV "Born Basic Anti-Bac" & "Scent Theory Keep It Clean"
Liq-E S.A. de C.V. "Optimus Instant Hand Sanitizer"
Maquiladora Minara S.A. de C.V. "Shine and Clean Hand Sanitizer
ITECH 361 "All Clean Hand Sanitizer Moisturizer and Disinfectant"

Registration Open: CDER SBIA Regulatory Education for Industry (REdI) Annual Conference August 25-28, 2020    This webcast workshop is FREE.  Register for either the Drugs Track on August 25 & 26, or the Devices Track on August 27 & 28.  Register and view the full agenda at: https://sbiaevents.com/redi2020/
July 24
Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
July 23
FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to the prescribing information.   This will help ensure that health care professionals discuss the availability of naloxone and assess each patient's need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed.  The patient Medication Guides will also be updated.

FDA Proposes New Rule on Reporting Requirement Under the Right to Try Act.  Today, the U.S. Food and Drug Administration published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA for any eligible investigational drug they provide to eligible patients under the Right to Try Act.  The FDA is dedicated to achieving the goals that Congress set forth in the Right to Try Act, so that patients facing terminal conditions have another avenue to access investigational medicines,
July 22
Guidance for Industry - Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research    Download your copy by Control/Click on the title above.
July 21
InHe Manufacturing, LLC and MHR Brands Issues Voluntary Nationwide Recall of Several Products Due to Potential Health Risk for Excess Lead   The Company was recently advised by the Florida Department of Health of the presence of elevated heavy metals (lead) in some of its MHR Brands and White Label product lines for humans and for pets.   In response to this information, the Company undertook an investigation and determined that the issue related to graduated droppers provided by a third-party packaging supplier.   Control/Click on the colored title above to see a list of product labels.
July 14
Today, the U.S. Food and Drug Administration (FDA) issued final guidance: Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.    Click on the colored guidance title to download it.