Mike DeSalvio
 

R&D Blog



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Regulating Controlled Substances and Precursor Chemicals; DEA Requirements

Due to current regulatory requirements for the Department of Justice and Drug Enforcement Administration, the purchase of commonly used lab chemicals has become harder to purchase. Published by the DEA, a listing of chemicals used to make controlled substances is broken down into two main categories, List I and List II and are referred to as Precursor Chemicals.

List I chemicals are highly regulated and require a DEA registration number in order to legally purchase, ship, transport, transfer, store, use or distribute in any form which also includes post consumption of product in the form as a waste. In the event of a transfer, both parties must have DEA registrations to legally transfer custody of the chemicals. The storage of List I chemicals requires a security plan which describes the secure storage of the chemicals, the active inventory and restricted access.

List II however, does not require a DEA Registration in most cases. This list includes chemicals such as Acetone, Sulfuric Acid, Hydrochloric Acid and 2-Butanone or Methyl Ethyl Ketone.

Purchasing Problems: Due to tightening restrictions on manufacturers and distributors of Precursor Chemicals, the sales departments generally request a DEA registration number for all listed chemicals, indifferent from those on List II or otherwise.

The regulations against Listed chemicals are enforced at the federal level which poses some confusion for instances that are outside the federal jurisdiction. The transfer, purchase or use of Listed Chemicals across state lines falls under the federal jurisdiction on the grounds or being assumed to be in “interstate commerce”. Alternatively, if no state line is crossed, the purchase is not within the federal jurisdiction. While it may be possible to purchase Listed Chemicals from a California based distributor for use at a California University, several issues come into play. 1) The distributor may obtain their stock from out of state, either manufacturing out of state, or purchase from an out of state manufacturer, thus interstate commerce applies. 2) we are victims of their supply chain. Remember that many companies don’t do business in just one state. This means if a California based distributor ships to Arizona as well, will the sales department have a double standard for purchases made from out of state customers and another set of standards for California based customers? Of course, this is referring to requesting a DEA registration number from your out of state customers and not your in-state customers. 3) Sales inventory and asset software is just as critical. Many companies have software that sales personnel use to place orders from customers over the phone. In many cases, data fields and entries must be standardized which does not provide the luxury of making the distinction between in-state and out of state customers. At this point, the sales reps require a DEA registration number from EVERYONE for any Listed Chemicals.

Most suppliers require two major forms of identification, usually a list of multiple accepted types ranging from Tax ID Number, Tax Exemption Number, DEA registration number or other state issued permit or registrations. The height in regulation is designed to verify the identity of an entity and weed out shell organizations which may attempt to purchase illegal regulated materials under a fake identification. More information will be provided as it becomes available but keep an eye on the federal register as new additions to List 1 generally go through notice and comment rule making procedures.

 

(a) List I chemicals
(1)  Anthranilic acid, its esters, and its salts 8530
(2)  Benzyl cyanide 8735
(3)  Ephedrine, its salts, optical isomers, and salts of optical isomers 8113
(4)  Ergonovine and its salts 8675
(5)  Ergotamine and its salts 8676
(6)  N-Acetylanthranilic acid, its esters, and its salts 8522
(7)  Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers 8317
(8)  Phenylacetic acid, its esters, and its salts 8791
(9)  Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers 1225
(10) Piperidine and its salts 2704
(11) Pseudoephedrine, its salts, optical isomers, and salts of optical isomers 8112
(12) 3,4-Methylenedioxyphenyl-2-propanone 8502
(13) Methylamine and its salts 8520
(14) Ethylamine and its salts 8678
(15) Propionic anhydride 8328
(16) Isosafrole 8704
(17) Safrole 8323
(18) Piperonal 8750
(19) N-Methylephedrine, its salts, optical isomers, and salts of optical isomers (N-Methylephedrine) 8115
(20) N-Methylpseudoephedrine, its salts, optical isomers, and salts of optical isomers 8119
(21) Hydriodic Acid 6695
(22) Benzaldehyde 8256
(23) Nitroethane 6724
(24) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2 (3H)-furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid lactone; gamma-hydroxybutyric acid lactone) 2011
(25) Red Phosphorus 6795
(26) White phosphorus (Other names: Yellow Phosphorus) 6796
(27) Hypophosphorous acid and its salts (including ammonium hypophosphite, calcium hypophosphite, iron hypophosphite, potassium hypophosphite manganese hypophosphite magnesium hypophosphite and sodium hypophosphite 6797
(28) N-phenethyl-4-piperidone (NPP) 8332
(29) Iodine 6699
(30) Ergocristine and its salts 8612
(b) List II chemicals:
(1) Acetic anhydride 8519
(2) Acetone 6532
(3) Benzyl chloride 8570
(4) Ethyl ether 6584
(5) Potassium permanganate 6579
(6) 2-Butanone (or Methyl Ethyl Ketone or MEK) 6714
(7) Toluene 6594
(8) Hydrochloric acid (including anhydrous hydrogen chloride) 6545
(9) Sulfuric acid 6552
(10) Methyl Isobutyl Ketone (MIBK) 6715
(11)Sodium Permanganate 6588

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Learning Management System Development

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A Learning Management System is a critical element to any business in need of a mass training solution. With an LMS the users have the ability to access customized training modules and courses, some of which come in media friendly versions. The general idea is to maintain a compliance with multiple regulatory agencies, training requires a verification process to assess or quantify that learning has taken place. This is where tests and quizzes come into play. The benefit of providing a comprehensive assessment is that an administrator can easily see who is compliant with training. Generally an 80% passing unit is used, meaning the lowest passing grade allowable is 80%. Many features are available with a custom LMS, including:

  • Grade distribution
  • Graphic Analysis
  • Analytics
  • Point distribution
  • Countdowns
  • Custom Workflows
  • Data Flexibility (import/ export)

  1. Training Modules are critical elements for an LMS for the principle reason of providing a segment of material in a format that can train employees outside a classroom. Many choose to use multimedia formats to achieve this feat but others may resort to assigned reading, supplemental materials and more.
  • Modules are available to integrate a wide variety of information into your LMS which provides your user with the ability to have more control while logged in. Critical modules like user permissions and grade tracking are very important to use because this functionality adds a great deal of control for the user.
  • Multimedia is an ever growing development. Only within the last five or six years have regulatory agencies fully recognized the use of videos for training purposes within an LMS to meet compliance. That being said, there are a great deal of considerations to be mentioned regarding the ethics of test making and the biases associated with training modules. These, we will touch upon in just a moment. The use of videos can be an extremely powerful tool for a training module but having a written or typed transcript of all recorded information is an important consideration to make.

2. Testing and Quizzes are a great way of assessing your sites learning retention and aptitude post training but is there a way to write them correctly?

  • Bias is a significant issue within a training module with regards to the content and narrator but there is also a wide range of bias associated with the testing method itself. Most testing modules will utilize multi-question formats which promote the use of Multiple Choice, True/ False, and Matching because these formats have pre-determined solutions or answers associated with them. The test writer can incorporate a wide range of bias within the assessment due to, in part by the question styles and basic content. If the same person or team writes the content for the training module, and also writes the content for the exam, there is a wide variety of cohesion between both. However, this is not always the case and often times, testing material may contradict the training content in a subtle way that can confuse a trainee. It is important to outline your content for both training and assessments while covering nothing more in these modules. This will ensure that all content is cohesive and accurate.
  • Validation and Verification is of key importance when administering a training module. Regulatory agencies require these provisions be made in an effort to assess the level of learning acquired or absorbed from the training module. The use of the various LMS functions and settings make this relatively easy but only if proper considerations have been made. Record retention and integrity are very important considerations with regards to document and record security. These requirements should be reviewed carefully with respect to your corresponding regulatory agency.
  • Many people have asked the question, How is it possible to gauge both compliance and learning in a work environment where testing as a form of training validation is not observed or tolerated? The answer is simple but resolves itself on a basic assumption. The causal relationship that is commonly associated with training as well as the lack-thereof plays a huge role in industry. Hence, training is performed to achieve a central goal; higher sales, lower injuries, maintain compliance, increase operational efficiency, reduce losses etc. If these goals have not been met in a post-training situation then the training has been a failure. In the context of safety compliance training, your validation of training is essentially the lack of workplace accidents, which could be directly related to the lack of worker’s comp claims. Regardless, the use of tests and quizzes with a learning management system integration is by far the most efficient method of assessing your sites success in respect to training modules. This can only be the case if proper considerations are made to mitigate the bias associated with those methods of validation.

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