DUBLIN – (BUSINESS WIRE) – May 26, 2021 –
the “FDA Regulation of Over-the-Counter Pharmaceuticals – What It Is, How To Analyze It, Make It Work For You” the conference has been added to ResearchAndMarkets.comoffer.
This 2-day online course is intended to equip participants with the knowledge and skills to develop and produce an over-the-counter drug product for marketing and sale in the United States.
Participants will gain an understanding of the different options available for the production and sale of an over-the-counter drug product, leave the workshop with an understanding of the United States Food and Drug Administration (“FDA”) regulations regarding these products and will receive strategic recommendations. to mitigate the risk of enforcement action in the future.
You have a headache? Are you back from lunch and now suffer from an occasional mild heartburn? Do you suffer from allergies? Got stuck in bed with a cough, sore throat, stuffy nose, and fever that you just can’t shake? Did you pitch the tent at Poison Ivy on last weekend’s family camping trip by mistake? Use deodorant?
Over-the-counter pharmaceuticals or “over-the-counter drugs” include many of the well-known products that we use to treat or control symptoms of occasional and moderate health problems. Available without a prescription and to buy directly from the shops, over-the-counter pharmaceuticals currently make up nearly 60% of all pharmaceuticals sold in the United States.
Anyone who has ever suffered from these occasional similar symptoms or conditions has likely relied on an over-the-counter drug product or “over-the-counter drug” to feel better. Enter any CVS, Wal-Mart, Meijer Grocery Story, Rite Aid Retail Pharmacy, or Target retail pharmacy in the United States; you’re sure to find shelves filled with hundreds, if not thousands, of different over-the-counter medications.
Some of the more widely recognized over-the-counter medications include ibuprofen tablets, anti-itch creams, nasal decongestant sprays, cough syrups, antacids, allergy medications, and topical pain relievers. Available without a prescription and purchased directly from the store, over-the-counter medications are safe and effective when properly labeled and used as intended.
The United States Food and Drug Administration (“FDA”) is responsible for the regulation and oversight of the United States over-the-counter drug market. Congress has granted the FDA regulatory authority over formulation, manufacture, labeling, marketing and promotion; and the import / export of OCT pharmaceuticals to the United States. Under this current regulatory regime, there are three pathways a company can take to enter the over-the-counter drug market, including (a) following an appropriate drug monograph; (b) with an Agency Approved New Drug Application (“NDA”); or (c) through the currently popular Rx-to-OTC switching process.
Market research suggests that there are currently over 300,000 over-the-counter drugs marketed and sold in the United States today and that number is increasing daily. This represents almost 60% of the total drug market in the United States (by purchase) and this number is expected to increase in the future. Based on these predictions alone, it is a profitable market and growth potential that drug and health product companies cannot afford to ignore.
If you can cook and follow a recipe; then you can make an over-the-counter drug product with access to the necessary resources and a proper facility.
- Gain an in-depth understanding of how over-the-counter pharmaceuticals are regulated in the United States
- Learn how to distinguish between a potential Rx drug and an over-the-counter drug.
- Recognize the difference between the various routes to market an over-the-counter drug product.
- Understand how to successfully identify and navigate an over-the-counter drug monograph.
- Recognize when it is appropriate to rely on a proposed rule, final rule and / or drug monograph.
- Understand how to determine if an ingredient is considered safe or GRAS / E for use in an over-the-counter drug and understand the difference between Category I, II and II ingredient designations.
- Identify the required elements of a compliant over-the-counter drug label.
- Eliminate strategies for marketing and promoting over-the-counter pharmaceuticals and mitigating potential law enforcement risks
- Have a working knowledge of the Rx-to-OTC switching process.
- Review and rate several of the FDA’s current OTC monographs.
Who should be present:
This includes those responsible for overseeing regulatory affairs, developing strategies for obtaining pharmaceutical approvals, and those responsible for ensuring corporate compliance.
Among others, this includes:
- Senior quality managers
- Quality professionals
- Regulatory Professionals
- Compliance professionals
- Production supervisors
- Manufacturing engineers
- Production engineers
- Design engineers
- Private Labelers and Labellers
- Contract manufacturers
- Custom importers and agents
- U.S. agents of foreign companies
- Process owners
- Quality engineers
- Quality auditors
- Document control specialists
- Records retention specialists
- Medical affairs
- Legal professionals
- Financial advisers and institutional investors
- Consultants, inspectors and cGMP experts
For more information on this conference, visit https://www.researchandmarkets.com/r/bcqpck
View source version on businesswire.com:https://www.businesswire.com/news/home/20210526005537/en/
Laura Wood, Senior Press Officer
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INDUSTRY KEYWORD: PHARMACEUTICAL HEALTH
SOURCE: Research and markets
Copyright Business Wire 2021.
PUB: 05/26/2021 6:27 a.m. / DISC: 05/26/2021 6:27 a.m.
Copyright Business Wire 2021.