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.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray together.
Updated by a group of distinguished regulatory experts, this new edition is a must-have handbook for regulatory professionals at all levels.
In light of the COVID-19 pandemic, the RAC Board has elected to offer online testing with live online proctoring this summer.
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.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
The RAPS store will be under maintenance Saturday, 6 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 06 July 2012 | By
The US agency in charge of setting drug production quotas for substances regulated under the Controlled Substances Act (CSA) is proposing a mid-year adjustment in its production quotas for the active pharmaceutical ingredients contained within many attention deficit hyperactive disorder (ADHD) drugs and painkillers in response to growing drug shortages.
In a 5 July 2012 Federal Register posting, the US Drug Enforcement Administration (DEA) announced it is looking to "adjust the established 2012 aggregate production quotas for some schedule I and II controlled substances." In doing so, DEA cited its authority under 21§1303.13 of the Code of Federal Regulations (CFR) which allows it to adjust the aggregate production quota if it determines there is a sufficient change in demand for a product. Part (c) of 21 CFR 1303.13 requires DEA to publish the proposed change in the Federal Register.
The largest proposed change in DEA's quota system would be for amphetamine salts, commonly used in attention deficit hyperactive disorder (ADHD) drugs. DEA is proposing to increase the quota by more than 32% from 25.3 million grams to 33.4 million grams.
The drugs have been in short supply for more than a year, and DEA has received criticism from consumers who complain of having a great degree of difficulty finding the drug. While the agency has previously placed blame for the situation on industry by saying results from manufacturing and distribution problems, its 5 July adjustment seems to indicate it is taking at least implicit responsibility for the problem. (See Regulatory Focus' 3 January story, 'ADHD Drugs Remain in Short Supply')
Another notable increase is the quota for hydromorphone, an active pharmaceutical used in certain opioid drugs including Palladone and Dilaudid. DEA said it is proposing to increase the API's quota by 173,000 grams.
Oxycodone, another opioid, will see its quota raised by 700,000 grams per year under the proposal while Oripavine, another opiate, will see a 5.5 million gram increase in its quota.
The majority of the remaining changes would be modest, with most API production quotas only increasing 10 grams for lesser-used drugs and other schedule I drugs only used for research purposes.
The agency is obligated under the CSA to set production quotas for schedule I and II drugs, which are defined as substances having a high probability of abuse. Schedule II drugs, unlike schedule I drugs, are available via a prescription and are seen as having a therapeutic benefit for patients. Access to schedule II drugs are typically restricted through Risk Evaluation and Mitigation Strategy (REMS) plans or other special access restrictions requiring proof of identification, limits on the amount of a drug able to be purchased or special licensing for pharmacists.
Comments on the proposal are due by 6 August 2012.
Read more:
DEA - Controlled Substances: Proposed Adjustment to the Aggregate Production Quotas for 2012
Tags: Quota System, ADHD, DEA, Opioids, Latest News, Drug Shortages
Regulatory Focus newsletters
All the biggest regulatory news and happenings.