Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Posted 03 January 2012 | By Alexander Gaffney, RAC
A shortage of a medication used to treat attention deficit hyperactive disorder (ADHD) shows little sign of abating as the US Drug Enforcement Administration (DEA) continues to regulate the amphetamine salts that act as the drug's active pharmaceutical ingredient (API).
The DEA controls the supply of the amphetamine salts via a manufacturing quota system, and authorizes certain amounts of the amphetamine salts to be distributed based on what the agency determines to be the actual medical need for the drug.
Critics maintain that the quota system has led to a shortage of the drug that has had an outsized effect on generic versions of the drug as manufacturers opt to use their limited supplies of the amphetamine salts to make pricier, brand-name products instead.
US Food and Drug Administration (FDA) officials have called for the DEA to recognize the issue of shortages, which according to the New York Times has led to a "rare open disagreement between two federal agencies." The FDA, however, has no say in how the DEA manages its quota system.
The DEA has responded to the FDA by stating that they believe the shortage issue is a result of marketing decisions made by industry, and that the quota system as it currently exists is adequate.
Said DEA spokeswoman Barbara Carreno, "Any shortage of these products is therefore a result of decisions made by industry regarding manufacturing or distribution." Carreno further noted that the DEA believes that the same issues causing other drug supply issues are likely to blame.
Industry, however, has deflected blame back to the DEA, calling the quota system the root of the issues-not manufacturers.
Tags: amphetamine salts, ADHD, DEA, Class II, Latest News, Shortage, API
Regulatory Focus newsletters
All the biggest regulatory news and happenings.