Do Your Part
  • Wash Your Hands
  • Avoid Close Contact
  • Cover your mouth and nose with a cloth face cover when around others
  • Cover coughs and sneezes
  • Clean and disinfect
For more information visit the CDC website here.
Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
April 30
Reopening Guidance for Cleaning and Disinfecting  This message includes updates on the COVID-19 response from the CDC.  The COVID-19 outbreak is a rapidly evolving situation and information will be updated on the  COVID-19 Situation Summary  as it becomes available. You can visit the page by Control/Click on the colored words above.
April 29
Warning Letters The following companies have received Warning Letters for marketing unapproved products related to Coronavirus Disease (COVID-19):
Hopewell Essential Oils
Santiste Labs LLC
Control/Click on the colored titles to read.
April 28
Warning Letters
Health Solutions Pharmacy Center Inc. dba Professional Compounding Pharmacy, Sammi A. Molvi Corvallis OR 97330
Among other citations:
Water was observed to be dripping from the ceiling of the ISO7 cleanroom, onto the floor.
Loose, unsealed ceiling tiles were observed in the ISO7 cleanroom.
A household air freshener was observed to be attached to the underside of an ISO5 workstation.
You failed to routinely clean the ISO5 area prior to aseptic operations.
You used non-sterile wipes to clean the ISO5 area.
You failed to use a sporicidal cleaning agent on ISO5 surfaces.
Your firm failed to perform adequate studies under dynamic conditions to demonstrate unidirectional airflow within the ISO5 area.

Shriram Institute for Industrial Research, Dr. K.M. Chacko, Delhi 110007 Delhi, India
Among other citations:
1. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(a)).
2. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)).
3. Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your raw materials and API conform to established standards of quality and/or purity.

Hawaii Pharm LLC, Mr. Pavel Kosyak, Honolulu, HI 96821
Among other citations:
1. You have not established identity specifications for any incoming herbal ingredients that you receive and subsequently use to manufacture your dietary supplement products.
2. You have not established finished product specifications for any of dietary supplements that you manufacture and distribute.
3. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a).
4. You failed to prepare a batch production record (BPR) every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(a).
5. Your firm does not have written procedures for product complaints.
6. Your firm does not have a written procedure for maintaining reserve samples, and you do not maintain reserve samples of any of the dietary supplement products your firm has manufactured.
April 21
FDA Authorizes First Test for COVID-19 Patient At-Home Sample Collection
The FDA re-issued the emergency use authorization for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp's Pixel by LabCorp COVID-19 Test home collection kit. The LabCorp home self-collection kit includes a specific Q-tip-style cotton swab for patients to collect their sample. After a patient self-swabs to collect their nasal sample, they mail their sample, in an insulated package included in the kit, to a LabCorp lab for testing. LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a doctor's order, in the coming weeks.
April 17
Avet Pharmaceuticals, Inc. Issued a Voluntary Nationwide Recall of Tetracycline HCl Capsules USP 250 mg and 500 mg Due to Failed Dissolution Specifications    These drug products are manufactured by Avet Pharmaceuticals Labs Inc. and distributed under the Heritage Pharmaceuticals Inc. label. The voluntary recall is being initiated due to low out of specification dissolution test results.  Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures.  For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable probability that if there is not enough tetracycline in the body to fight the infection, this could result in rapid progression of the infection and death.

International Laboratories, LLC Issued a Voluntary Nationwide Recall of One Lot of Clopidogrel Tablets USP, 75 mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC #54458-888-16; Lot #117099A.   The product is labeled as Clopidogrel tablets USP 75 mg, a platelet inhibitor (blood thinner), but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.   Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening. 

Amneal Pharmaceuticals Issued a Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodiumethylamine (NDMA) Impurity Amounts Above the Levels Established by FDA.   NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
April 10
New Emergency Use Authorization (EUA) to Decontaminate Respirators    The U.S. Food and Drug Administration has granted an emergency use authorization to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide to decontaminate compatible N95 or N95-equivalent respirators.   Hydrogen peroxide sterilization is a low temperature sterilization process that utilizes hydrogen peroxide vapor. The vapor fills the sterilization chamber, penetrates the device and sterilizes exposed surfaces. The STERIS V-PRO Decontamination Cycle is capable of processing 10 respirators at one time through a process that takes approximately 28 minutes to complete. Each respirator can be processed up to 10 times for single-user reuse.    
April 8
FDA Has Approved the First Generic of Proventil HFA, the Commonly Used Albuterol Sulfate Inhaler to Treat and Prevent Bronchospasm.    According to the National Heart, Lung, and Blood Institute, bronchospasms occur when the muscles surrounding the airways swell and tighten, causing them to squeeze the airways and make them smaller. Exercise and other physical activity can bring on symptoms in most people who have asthma and may occur either during or right after being active. Asthma causes recurring periods of wheezing (a whistling sound when breathing), chest tightness, shortness of breath and coughing. The coughing often worsens at night or early in the morning. Asthma affects people of all ages, but it most often starts during childhood. In the United States, more than 26 million people are known to have asthma, about 7 million of these people are children.
April 3
Update on non-eCTD Submissions to Office of Prescription Drug Promotion (OPDP)
Recognizing that some submissions will be exempt from the eCTD requirement (i.e. Advisory Submissions, Amendments, Response to Information Requests, etc), CDER is providing an alternate electronic submission pathway to sponsors or applicants. OPDP encourages submissions to be made electronically via CDER NextGen Portal for submissions covered under such exemptions rather than paper or physical media. For information on how to organize a submission covered under such exemptions, please refer to the Providing Regulatory Submissions in Alternate Electronic Format; Draft Guidance for Industry. Please note the draft guidance says to submit via ESG, however, CDER has since opened the CDER NextGen Portal to accept these submissions as well. For additional information on the promotional submissions which will be exempt from eCTD submission requirements and the contents of those submissions, please refer to the Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs; Final Guidance for Industry. Any questions related to the submission promotional materials to CDER may be sent to the email address
April 1
The FDA Is Requesting Manufacturers Withdraw All Prescription and Over-The-Counter (OTC) Ranitidine Drugs (Listed Reference Drug: Zantac) From the Market Immediately.   This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). NDMA is a probable human carcinogen (a substance that could cause cancer). FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.   The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products.   To date, the FDA's testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).