August 28-29 * 4th Annual Regulatory Workshop
Offices of Buchanan Ingersoll & Rooney * Washington, D.C.
Specialty Pharma Industry News is provided by SPA Member Dr. Larry Boos
May 31
Outbreak Investigation of Salmonella Concord Linked to Tahini.  Tahini is made from sesame seeds and can be served on its own or used as an ingredient in Mediterranean and Middle Eastern Halva was added to Import Alert 99-19 for products that appear to be adulterated due to the presence of style dishes, such as hummus, falafel, and baba ganoush.     On May 30, 2019 Karawan Tahini and Halva were added to Import Alert 99-19 for products that appear to be adulterated due to the presence of Salmonella, which allows the FDA to detain products without physical examination.  The tahini of concern may be labelled as either "Karawan Tahini," "El-Karawan Tahini," or "Soco Tahini." Consumers should avoid eating this tahini. This tahini was sold in bulk to retailers and restaurants and was also available to consumers at retail locations and online. It may have also been used in other food products sold to consumers. Consumers should be aware that this product has a shelf life of two years and should check their homes for tahini with either label. Consumers with this tahini in their home should not eat it and should discard it.

PECGEN DMX by NOVIS PR: Recall - Due to a Labeling Error  Novis PR LLC is voluntarily recalling 5 lots of PECGEN DMX, 16 ounces, a liquid cough syrup to the consumer level. The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician.  The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
May 30
FDA is Working with the Food Industry to Reduce Confusion Over Date Labels Between the food industry and consumers, Americans are throwing out about a third of our food - approximately 133 billion pounds or $161 billion in food each year - according to estimates from the U.S. Department of Agriculture.  Part of the problem is that date labeling on packaged foods isn't user-friendly. It has been estimated that confusion over the multitude of different date labeling terms on food products accounts for about 20 percent of food waste in the home. "Use before," "sell by" and "expires on" are just some of the terms used,  Read this article to learn if what you're eating is good to eat-and how to reduce waste in your home.
May 28
FDA approved lenalidomide (REVLIMID, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL). More Information. May 28, 2019.  Read more at this link.

Webcast: FDA unveils validated method to detect major foodborne pathogen linked to consuming imported fresh produce. Thursday, June 13, 2019 12:00 p.m. - 1:00 p.m. EST Register here for webcast (public attendees and FDA staff) CE Credit Available  Presented by: Alexandre da Silva, Ph.D., Senior Biomedical Research Microbiologist
FDA's Center for Food Safety and Applied Nutrition Parasitology Laboratory
About the Presentation: Cyclospora cayetanensis, a significant foodborne pathogen causing the diarrheal illness cyclosporiasis, has emerged worldwide. In the U.S., C. cayetanensis has caused large and complex outbreaks, mainly linked to consuming imported fresh produce like cilantro.

Prepare for Hurricane Season.  People living along the coast aren't the only ones who need to prepare for hurricanes. These storms can cause damage even if you live hundreds of miles from the shore.   The 2019 Atlantic hurricane season officially begins on June 1. If you're in an area where hurricanes are a risk, you need a plan. Before the first hurricane hits, take time to plan for yourself and your family.   The Preparedness and Safety Messaging for Hurricanes, Flooding, and Similar Disasters  document contains messages about a range of topics including food safety, carbon monoxide poisoning, waterborne diseases, and mold.
May 24
Recall Notice - All Sterile Compounded Drugs by Pharm D Solutions, Houston Texas: Recall - Due to a Potential Lack of Sterility Assurance.   All sterile compounded drugs by Pharm D Solutions are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.  Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in serious injury or death.

Brodt Zenatti Holding LLC. Recalls Karawan Brand Tahini & SoCo Brand Tahini Because of Possible Health Risk    Brodt Zenatti Holding LLC of Jupiter, Florida is recalling all retail and bulk Karawan brand Tahini, sold in Jars: 450g (15.87 oz) and Buckets: 17kg (599.6 oz) that were imported from Palestine between the dates of December 2018 to April 2019 and SoCo Brand Tahini; because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Karawan brand Tahini was directly distributed to New York and Texas. We currently know that distributors have thereafter shipped the product to Massachusetts and Virginia.

The Village Company Issued a Voluntary Nationwide Recall of The 22 ounce La Bella Extreme Sport Styling Gel Due to Bacterial Contamination.  Four lots failed micro testing due to bacterial contamination, resulting in potential contamination of 2,377 cases (or 9,508 units). The bacterium found is Burkholderia cepacia and a group of related strains.  Burkholderia cepacia and group of related strains rarely cause infections in healthy people, but pose serious risk to individuals with cystic fibrosis, weakened immune systems, and chronic lung disease. If you are feeling ill after having used the product, consult with your doctor. Washing your hands, hair brush, combs and other hair items, counter tops and other surfaces with warm soapy water are good practices to help prevent the spread of bacteria.

Federal Judge Enters Consent Decree of Permanent Injunction Against Compounder PharMedium Services for Violations at Multiple Facilities.  The company headquartered in Lake Forest, IL has four registered outsourcing facilities located in Memphis, Tenn.; Cleveland, Miss.; Sugar Land, Texas; and Dayton, N.J.   The government alleges that PharMedium manufactured and distributed drugs intended to be sterile, such as oxytocin and morphine sulfate, that were adulterated because the drugs were made under insanitary conditions.   The complaint also alleges that PharMedium distributed unapproved new drugs and drugs that were misbranded because their labeling did not bear adequate directions for use.

FDA Issues Guidance for Industry: Section 503A Bulks List Final Rule Questions and Answers - Small Entity Compliance Guide.  Today, FDA issued a guidance to provide clear answers to questions on the recently published final rule that establishes the agency's criteria for evaluating bulk drug substances that may be used to compound drugs under section 503A of the Federal Food, Drug and Cosmetic Act. That rule places six substances on the 503A bulks list. It also identifies four substances that were considered and were not included on the list. This rule went into effect on March 21, 2019.

FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies.  The U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S.; previously, tests for detecting Zika virus IgM antibodies-including the ZIKV Detect 2.0 IgM Capture ELISA-had been authorized only for emergency use under the FDA's Emergency Use Authorization (EUA) authority.  Read more

August 28-29 * 4th Annual Regulatory Workshop
Offices of Buchanan Ingersoll & Rooney * Washington, D.C.

May 23
Warning Letters
Petra Hygienic Systems Int. Ltd, Concord ON L4K 4R8, Canada
During our inspection the following violations were observed:
1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release.
2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals.
3. Your firm failed to establish adequate written procedures for cleaning and maintenance of equipment.
4. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures
In addition, your firm lacked adequate written procedures for various functions, including, but not limited to: Quality Unit responsibilities, vendor audits, and corrective actions and preventive actions.

Centurion Laboratories Private Limited, Manjusar 391775 Gujarat, India
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated
1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards.
2. 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.
3. Your firm failed to follow written procedures for cleaning and maintenance of equipment.

FDA cleared the first diagnostic tests for extragenital testing for chlamydia and gonorrhea.  Today, the U.S. Food and Drug Administration cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually-transmitted infections, respectively, chlamydia and gonorrhea, through diagnostic testing of extragenital specimens. The Aptima Combo 2 Assay and the Xpert CT/NG are the first devices cleared for extragenital diagnostic testing of these infections via the throat and rectum. These tests were previously only cleared for testing urine, vaginal and endocervical samples.   According to the Centers for Disease Control and Prevention's Sexually Transmitted Infections Surveillance Report, the rate of sexually transmitted infections is steadily increasing, with an estimated 1.7 million cases of chlamydia and more than 500,000 cases of gonorrhea in the U.S. in 2017 alone. Both infections can be contracted through vaginal, anal or oral intercourse. Typically, both infections can be easily treated, but if left untreated, both infections can cause serious complications for patients, including infertility.

Products with Hidden Drug Ingredients
Man Fuel Male Enhancement Shooter contains Tadalafil (Cialis) and Desmethyl Carbodenafil (a substance structurally similar to sildenafil (Viagra); both of which are used to treat E.D. (Erectile dysfunction. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Man Fuel Extreme Edition contains sildenafil (Viagra), dithiodesmethyl carvodenafil and desmethyl carbodenafil (structurally similar to sildenafil).

Outbreak Investigation of Salmonella Infantis Linked to Del Monte Vegetable Trays.  The Food and Drug Administration (FDA) is inspecting the Del Monte facility in Kankakee, Illinois that produced vegetable trays that the Wisconsin Department of Health Services linked to an outbreak of salmonellosis.   On May 21, 2019, the Wisconsin Department of Health Services announced that vegetable trays produced by Del Monte Fresh Produce Inc. and sold at Kwik Trip convenience stores in Wisconsin and Minnesota are linked to three illnesses in Wisconsin and one illness in Minnesota.  The FDA, CDC and state authorities from Wisconsin and Minnesota continue to investigate the cause and source of the outbreak and the distribution of products.
May 22
The Truth About Aging and Dementia    Dementia is not a normal part of aging. Read more to learn what the differences are between normal aging and dementia.  Want to know even more, then go to The World Health Organization's  Guidelines on risk reduction of cognitive declines and dementia.
May 17
FDA Warns Manufacturers of Products Labeled as Homeopathic for Putting Consumers at Risk with Significant Violations of Manufacturing Quality Standards. The FDA has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations. Products labeled as homeopathic have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality. Products labeled as homeopathic can be made from a wide range of substances, including ingredients derived from plants; healthy or diseased animal or human sources; minerals and chemicals. These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products and are widely available in the marketplace. These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured which can lead to contamination, or may contain active ingredients that are not adequately tested or disclosed to patients. The warning letters issued to Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It, Inc., and Bershtel Enterprises LLC, doing business as WePackItAll, describe failures to conform to CGMP requirements due to improper methods, facilities or controls for manufacturing, processing and packing. These companies jointly manufacture and package Puriton Eye Relief Drops, which are labeled as homeopathic. These companies jointly manufacture and package Puriton Eye Relief Drops, which are labeled as homeopathic. Another warning letter was issued to Newton Laboratories for human drug CGMP and misbranding violations, as well as unapproved new animal drug violations. One example of this company's products is nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. Earlier this year, the FDA issued separate warning letters to additional companies regarding violative products labeled as homeopathic:
* [4/1/19]: FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards
* [3/19/19]: FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions

May 15
FDA Advises Consumers, Tattoo artists, and Retailers to Avoid Using or Selling Certain Tattoo Inks Contaminated with Microorganisms. The following tattoo inks have been recalled because they are contaminated with microorganisms:
Scalpaink SC, Scalpaink PA, and Scalpaink AL basic black tattoo inks manufactured by Scalp Aesthetics (all lots)
Dynamic Color - Black tattoo ink manufactured by Dynamic Color Inc (lots 12024090 and 12026090
Solid Ink- Diablo (red) tattoo ink manufactured by Color Art Inc. (dba Solid Ink) (dba Antone's Ink) (lot 10.19.18)

May 13
Novartis Issues Voluntary Nationwide Recall of Promacta (eltrombopag) 12.5 mg for Oral Suspension Due to Potential Peanut Contamination.   Promacta tablets in 12.5 mg, 25 mg, 50 mg, and 75 mg strengths are not impacted by this recall and are not manufactured in the same facility.

FDA/CDER Report on the State of Pharmaceutical Quality. This is a yearly snapshot of the pharmaceutical manufacturing industry's ability to deliver quality products to the U.S. market.  To read the report, please visit: Report on the State of Pharmaceutical Quality.
May 9
Final Guidance for Industry "Determining Whether to Submit an ANDA or 505(b)(2) Application".  This serves as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, & Cosmetic Act is appropriate for the submission of a marketing application for a human drug product to the FDA. 
May 3
FDA Advises Consumers to Stop Using Dietary Supplements from Life Rising Corporation Because They May Be Contaminated With Lead. Samples of the following products tested  positive for lead during FDA testing: Holder-W Holder Warmer, Metabolism Cleansing  (MET-CLS), and Neck-ND Neck Clear. The FDA recently sampled and tested targeted dietary supplement products as part of a follow-up inspection to a previous company recall involving lead contamination and a related Warning Letter issued to the company in 2017. The FDA notified the company, Life Rising Corporation, that their products were contaminated with lead and the company has agreed to issue a voluntary recall.