The Specialty Pharma Association would like to extend our wishes to everyone for a very Merry Christmas, Happy Hanukkah, and a Safe and Happy New Year!
Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
November 30
Drug Master File (DMF) and Drug Substance Workshop on March 3-4, 2021  This workshop is Free.   Some of what will be discussed:   Information on submitting and managing DMFs, fee payments, and facility identification, How to maximize communication tools offered by the agency to get answers to your questions, and Common mistakes and how to avoid them -case study examples
November 27
Guidance Documents (Control/Click to read)

Warning Letters
Aurolife Pharma, LLC, Madan Reddy, Director, Hyderabad 500084 Telangana, India
During our investigation of your manufacturing facility our investigators observed:
1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.
2. Your firm failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair.
3. Your firm failed to establish and follow written procedures for cleaning and maintenance of equipment.
4. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess

Family Pharmacy of Statesville, Inc., Joshua Eudy, CEO Family Pharmacy of Statesville, Statesville, NC 28625
Based on our inspection it appears that you are violating Section 503 A of the FDCA in that
1. Receipt of valid prescriptions for individually identified patients
In addition, your firm prepared, packed, or held under insanitary conditions drug products:
2. Your firm did not use as sporicidal agent in ISO 5 Areas
3. Your firm reused bottles for use in the ISO 5 area without assurance that the bottles remained sterile after multiple uses.
4. Your firm handled hazardous drugs without providing adequate cleaning of work surfaces.
5. Material flows directly from an unclassified area into a room in which sterile production occurs via a pass-through window.
6. Your firm produced drug products with materials that had not been verified to assure that they did not contribute to endotoxin contamination that may be objectionable given the product's intended use.
7. Your firm failed to confirm that the quality of water was suitable for its intended use in the production of non-sterile drug products.
8. Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
More - too numerous to mention

Nartex Laboratorios Homeopaticos S.A. de C.V., Eduardo Acosta CEO, Torreon, Coah.Mexico During our inspection, our investigator observed specific violations and deviations including, but not limited to, the following.
1. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess.
2. Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality

November 25
Recorded (Free) Webinar:  Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions   This webinar and the guidance it accompanies are intended to help applicants submitting an abbreviated new drug application (ANDA) seeking approval of a generic drug [View Recording]
November 24
Free CDER Compliance Conference, January 14, 2021, 8:30 a.m. 4:30 p.m.  In SBIA's first conference dedicated to compliance, participants will learn from FDA subject matter experts on a range of drug compliance topics including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance. Presenters will discuss questions from the audience after each presentation. {REGISTER]
November 23
FDA Expands Approval of Influenza Treatment of Xofluza (baloxavir marboxil) to Post-Exposure Prevention  "This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic," said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research. "Americans will have to be more vigilant than ever as these viruses spread concurrently."
November 19
Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19     Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).   FDA Commissioner Stephen M. Hahn, M.D. said, "As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19."
November 18
Public Notification: Livtone contains hidden drug ingredients.  The Food and Drug Administration is advising consumers not to purchase or use Livtone, a product promoted for weight loss.   FDA laboratory analysis confirmed that Livtone contains sibutramine and fluoxetine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.  Fluoxetine is an FDA-approved drug in a class of drugs called selective serotonin reuptake inhibitors (SSRIs).  Uses of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. 

Public Notification: Vigorous Man contains hidden drug ingredient. FDA laboratory analysis confirmed that Vigorous Man contains sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction. FDA's approval of Viagra is restricted to use under the supervision of a licensed health care professional.
November 17
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home.   Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
November 16
The FDA has Published a New Webpage, A Closer Look at COVID-19 Diagnostic Testing.   It will be available to provide health care providers and other public health professionals, including those who might purchase COVID-19 tests, more technical information and resources. The article is also available in PDF for easy printing and distribution. This webpage is a companion to another overview of COVID-19 testing on our site which provides patients and consumers plain language information about both diagnostic and antibody testing for COVID-19.

FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs.   Today, the U.S. Food and Drug Administration approved Stelfonta (tigilanol tiglate injection) to treat dogs with non-metastatic, skin-based (cutaneous) mast cell tumors (MCTs). The FDA is also approving Stelfonta to treat non-metastatic MCTs located under the dog's skin (subcutaneous), in particular areas of a dog's leg.  Stelfonta is injected directly into the MCT (intratumoral injection). Stelfonta works by activating a protein that spreads throughout the treated tumor, which disintegrates tumor cells
November 13
To read more Control/Click on the underlined title above.
November 10
Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination      This product is sourced and repackaged from Sunstar Americas Inc. who has notified us the product may be contaminated with the bacteria Burkholderia lata.   In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.   The prescription oral rinse product, available through institutional use only, is indicated for use as part of a professional program for the treatment of gingivitis.
November 9
The FDA Issued an  emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.    Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
November 6
November 2
Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
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