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Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
September 30
Free Drug Registration and Workshop Webcast, October 8, 2020.    Topics Covered:  1. Labeler Code Requests,  2. Establishment Registration,  3. Drug Listing,  4. 503B Compounder Product Reporting using CDER Direct, 5. Establishment Registration and Drug Listing Compliance Program, and 6. All sessions include a Q&A panel.  Control/Click here >>  REGISTER

Hand sanitizers Recalled due to presence of undeclared Methanol (Wood Alcohol) Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects. Companies included in the recall:
DDM Vission, S.A. DE C.V. - Cleaner Hand Sanitizer AJR Trading LLC - bio aaa Advance Hand Sanitizer 480 ml bottles
Medek - M Hand Sanitizer Alcohol Antiseptic 80%
Open Book Extracts - Always Be Clean Hand Sanitizer and Just Hand Sanitizer

Also CorgioMed, LLC - Leefree Instant Hand Sanitizer Aloe Vera is improperly labeled "edible alcohol"

Warning Letters HFL Solutions, LLC, Sam Robbins Ahdoot, Owner; Playa Vista, CA 90094
1. You promote CholesLo as a dietary supplement, but it contains Lovastatin an active ingredient in Mevacor and its generic counterparts, consequently it cannot be marketed as a dietary supplement.
2. Your AlphaViril, Blood Flow Optimizer, Blood Pressure Optimizer, Blood Sugar Optimizer, CHEATmeals, CholesLo, Inflame & Pain Relief, LeanOptimizer, Perfect Vitamin D & K, and ProVanax products are not generally recognized as safe and effective for the uses you promote and therefore are "new drugs" that have not been approved by the FDA and cannot be introduced into interstate commerce.

Essential Pharmaceutical Corp, Bruce Y. Lin, President; Pomona, CA 91768
1. Your firm manufactures and distributes "BIO-MINT Nasal Spray," which is an unapproved new drug and is being marketed as a nonprescription, over-the-counter (OTC) drug product. "BIO-MINT Nasal Spray" is a drug under section 201(g)(1)(B) of the Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.
2. Our inspection revealed serious violations of the FDA's regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). Specifically,
A. You failed to establish specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)
B. You failed to establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e).
C. You failed to establish specifications for dietary supplement labels, as required by 21 CFR 111.70(d).
D. You failed to establish and follow all required written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting reprocessing as required by 21 CFR 111.103.
E. You failed to prepare a Master Manufacturing Records (MMRs) that includes the information specified in 21 CFR 111.210. One example is that a complete list of components to be used is not included in the MMRs as required by 21 CFR 111.210(b).
F. You failed to prepare a batch production record every time you manufactured a batch of dietary supplements with the information required by 21 CFR 111.255(b).
G. You did not maintain, clean and sanitize equipment, and contact surfaces used to manufacture or hold components or dietary supplements as required by 21 CFR 111.27(d).
H. And Much More - see the Warning Letter for complete explanations

LEC Custom Products, Inc. Jeremy Willard, CEO; Brampton ON L6T 5G5 Canada
During our inspection our investigator observed the following some of which are repeat violations:
1. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).
2. Your firm failed to establish 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 (21 CFR 211.100(a)). Your firm lacked a process validation program.
3. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
4. Your firm failed to establish a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
5. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)).
6. Your firm failed to establish an adequate quality unit and the responsibilities, and procedures applicable to the quality control unit were not in writing and fully followed (21 CFR 211.22(a)&(d)).

Front Door Pharmacy, LLC dba Pure Pharmacy, Henry Shui, Owner; Houston, TX 77054 Based on our inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
1. The FDA investigator noted that drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA.
a. An operator exposed his bare hands by changing gloves inside the ISO 5 LAF hood during aseptic operations. Furthermore, once donned, the gloves did not cover the skin and hair around his wrists.
b. The ISO-classified areas had visibly dirty equipment and difficult to clean surfaces.
c. Your firm maintained the ISO 5 LAF hood in a powered-off state until (b)(4) prior to beginning aseptic processing and did not disinfect with a sporicidal agent prior to producing sterile drug products.
d. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area.
e. Air vents within your classified areas were located on the ceiling, adjacent to the HEPA filters. Therefore, your firm had no assurance of proper air circulation within the classified areas.
f. Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves. And much more....

Panacea Biotec Limited, Rajesh Jain, Managing Director, New Delhi 110044 Delhi India
During our inspection, our investigators observed:
1. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
2. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
September 29
Guidance for Industry                                                                                          
September 25
FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)    The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine diphenhydramine (Benadryl) can lead to serious heart problems, seizures, coma, or even death. We are aware of news reports of teenagers ending up in emergency rooms or dying after participating in the "Benadryl Challenge" encouraged in videos posted on the social media application TikTok. When used as recommended, it is a safe and effective medicine.
September 24
FDA Issues Recommendations Regarding Mercury-Containing Dental Amalgam Dental amalgam  (sometimes improperly referred to as "silver amalgam") is a mixture of mercury and a powdered alloy made up of silver, tin and copper. The amalgam releases small amounts of mercury vapor over time.   How much vapor is released can also depend on the age of the filling as well as a person's habits such as teeth grinding.  Uncertainties remain about: the effects that long-term exposure to dental amalgam may have on the specific high-risk groups we've listed above; the potential for mercury in dental amalgam to convert to other mercury compounds in the body; and whether the accumulation of mercury in some body fluids and tissues results in other unintended health outcomes (such as mouth cancer).
September 23
Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level.  The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration.

The FDA is requiring the Boxed Warning, FDA's most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class.   Benzodiazepine prescriptions include alprazolam (38%) being the most common followed by clonazepam (24%) and lorazepam (20%).   Also, be advised to take precautions when benzodiazepines are used in combination with opioid addiction medications.
September 18
Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency   One lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] are being recalled to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4).
September 17
Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book. Webcast October 27-28, 2020. In the first-ever Orange Book Conference, FDA will showcase the Orange Book and provide a roadmap for the rich information it contains. This conference is a great opportunity for the brand and generic drug industries, and other interested public health stakeholders, to hear from the agency's Orange Book experts, and provide feedback on its use and functionality. This event is FREE. REGISTER
September 16
FDA Encourages Use of Drug Master Files to Further Support Cannabis Research   The FDA is alerting those involved in research on drugs containing cannabis and cannabis-derived compounds of the potential benefits of using Drug Master Files (DMFs). The agency has heard concerns from some stakeholders about their ability to protect proprietary information while participating in drug development. FDA has given these concerns much thought and is suggesting that stakeholders involved in research and development of drugs that contain cannabis and cannabis-derived compounds who have these concerns consider the Drug Master File (DMF) pathway.  In July 2020, FDA published a draft guidance ("Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry") to provide FDA's current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds.  For more information on DMFs and the guidance please see our recently recorded webinar, "Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations."
September 15
How High Fructose Intake May Trigger Fatty Liver Disease    Studies suggest that high fructose intake may increase the risk of non-alcoholic fatty liver disease (NAFLD), in which too much fat is stored in liver cells. Fatty liver disease can lead to liver inflammation and liver damage, resulting in a more aggressive disease called non-alcoholic steatohepatitis (NASH). NASH can progress to scarring of the liver (cirrhosis), liver cancer, and liver failure.   A major source of fructose is high fructose corn syrup (HFCS), an inexpensive substitute for cane sugar that was introduced in the 1970s. It's now used to sweeten a variety of foods, including soda, candy, baked goods, and cereals.   To read more go to:

FDA issues draft guidance on geriatric information in product labeling    Today, the U.S. Food and Drug Administration issued the draft guidance for industry  "Geriatric Information in Human Prescription Drug and Biological Product Labeling - Guidance for Industry and FDA Staff."     Geriatric patients are patients 65 years of age and older. Manufacturers should ensure the appropriate geriatric use information is consistently placed in prescription drug labeling so that the information is clear and accessible to health care professionals and guides the safe and effective use of prescription drugs in geriatric patients.
September 2
UV Lights and Lamps, Disinfection, and Coronavirus     Consumers who may be interested in purchasing ultraviolet-C (UVC) lamps to disinfect the home or similar spaces should read the FDA's answers to common questions about the use of these lamps for disinfection during the COVID-19 pandemic. Go here.
September 1
FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs   Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and Drug Administration has undertaken a thorough investigation in an effort to protect patients. While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.  To read more go to the FDA Statement here.