Laws Regarding Controlled Substances and the Controlled Substance Act
This CE presentation reviews federal, as well as Alabama-specific, pharmacy laws, rules, and regulations that pertain to controlled substances. These laws, rules, and regulations apply to pharmacists practicing throughout the Alabama health-system. Knowledge of this information is required in order for pharmacists to successfully pass the Alabama MPJE.
Target Audience
This knowledge-based program is intended for Pharmacists (ACPE).
Learning Objectives
- Explain the Controlled Substances Act
- Recognize the Schedules of Controlled Substances.
- Describe the required elements of controlled substance prescriptions
- Explain laws related to electronic prescribing (E-Prescribing) of controlled drugs
- Define laws pertaining to mid-level practitioners
- Identify regulations surrounding emergency filling of controlled substances.
- Define laws pertaining to Schedule III, IV, and V drugs including refills, partial filling, and how they may be ordered from a pharmacy (i.e., electronic, fax, phone, etc.).
- Outline opioid addiction treatment program laws, and all laws pertaining to the prescribing of methadone and buprenorphine +/- naloxone.
- Explain the role of the DEA in enforcing the Controlled Substances Act.
- Identify the legitimate handlers of controlled substances and their licensing requirements.
- Recognize the differences between Schedule I and Schedule II-V drugs in terms of medical use and abuse potential.
- List the requirements for pharmacy registration with the DEA.
- Identify the procedures for renewing pharmacy registration.
- Explain the process for transferring business operations involving controlled substances.
- Recognize the requirements for ordering controlled substances using DEA Form 222 and the Controlled Substance Ordering System (CSOS).
Laws Regarding Controlled Substances and the Controlled Substance Act RECORDED PROGRAM PACKET.pdf
A copy of the presentation slides are located within the course content. Once you have registered for the course, please navigate to the 'Take Course' tab and click the navy blue 'Take Course' button. Navigate to the 'Course Materials' section of the course using the left-hand menu and download a PDF version of the program presentation.
Scott Penzak, Pharm.D. is Department Head and Professor in the Department of Pharmacy Practice, joining the Harrison School of Pharmacy on Dec. 1, 2018. Prior to joining the Harrison School of Pharmacy, Penzak totaled more than 12 years of experience as a researcher with the National Institutes of Health and nine years of academic experience at the University of North Texas and Mercer University.
Penzak is a 1990 graduate of Ferris State University with a bachelor of science degree in pharmacy. He went on to complete his Pharm.D. at Wayne State University in 1996. Upon graduation, he was a research fellow for two years at the University of Arkansas for Medical Sciences, studying infectious diseases pharmacology.
Penzak joined the HSOP faculty following a position at the University of North Texas Health Sciences Center in the College of Pharmacy from 2014-18. While there, he has served as professor and vice chair of the Department of Pharmacotherapy while also serving as interim associate dean for academic affairs from 2016-17.
Prior to his arrival at North Texas, Penzak spent 12 years as the director of the Clinical Pharmacokinetics Research Laboratory (CPRL) at the National Institutes of Health (NIH) in Bethesda, Maryland. He also spent three years (1998-2001) as an assistant professor of pharmacy practice at Mercer University.
Penzak’s research is focused mainly on pharmacokinetics, pharmacogenetics, drug-drug, and drug-herb interactions with antiretroviral medications. From a clinical pharmacy service perspective, he routinely assists clinicians with therapeutic drug monitoring and drug interaction management in HIV-infected patients.
While with the NIH, Penzak was the director of the Clinical Pharmacokinetic Research Laboratory (CPRL), a unit that assists clinical investigators in the design, analysis, and interpretation of pharmacokinetic studies. The CPRL supports NIH scientists in several major areas of pharmacokinetic research, including drug interaction studies and characterization of drugs with nonlinear disposition. While director of the CPRL, he received three Directors Awards at NIH for scientific achievement (2005, 2013) and patient care (2012). In 2008 he was a recipient of the NIH Mentoring Award.
With research funding from organizations such as the NIH, American Association of Colleges of Pharmacy, and others, Penzak has generated more than 150 publications. He also serves on the editorial boards for publications such as the Journal of Clinical Pharmacology, Pharmacotherapy, European Journal of Drug Metabolism and Pharmacokinetics, and the International Journal of Pharmacokinetics. In 2017, Penzak was recognized as a Fellow in the American College of Clinical Pharmacology.
Auburn University is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education; credits are recognized nationwide. The Universal Activity Number for this knowledge-based program is 0001-0000-25-033-H03-P and is intended for pharmacists. The initial release date for this home-study program is September 18, 2025, and the intended expiration date is September 18, 2028.
Disclosures: There is no commercial support being received for this program. Dr Penzak and others in control of content have no actual or potential conflict of interest in relation to this program.
Available Credit
- 4.50 ACPE PharmacyAuburn University is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education; credits are recognized nationwide.
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