Federal Laws and Regulations
The information contained on this website is provided for informational purposes only and should not be construed as legal advice on any matter. The Information constitutes general information of applicable administrative regulation and/or laws related to general topics in the arena of controlled substance misuse and abuse and may not reflect current legal developments and updates. Please refer to the federal legislature for any potential changes.
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Code of Federal Regulations
EUR-Lex Access to European Union Law
U.S. Code: Title 18
U.S. Code: Title 21
U.S. Pharmacopeia (USP)
Federal Legislation Passed into Law
- PUBLIC LAW 100-71 – JUL 11, 1987 – Drugs and Drug Abuse
- PUBLIC LAW 104–237 – OCT. 3, 1996 – Comprehensive Methamphetamine Control Act of 1996.
- PUBLIC LAW 109–469 – DEC. 29, 2006 – Office of National Drug Control Policy Re-authorization Act of 2006.
- PUBLIC LAW 110-143 – DEC. 21, 2007 – Methamphetamine Remediation Act of 2007.
- PUBLIC LAW 110–199 – APR. 9, 2008 – Second Chance Act of 2007: Community Safety Through Recidivism Prevention.
- PUBLIC LAW 111–273 – OCT. 12, 2010 – Secure and Responsible Drug Disposal Act of 2010.
- PUBLIC LAW 112–144 – JULY 9, 2012 – Food and Drug Administration Safety and Innovation Act.
- PUBLIC LAW 114–91 – NOV. 25, 2015 – Protecting Our Infants Act of 2015.
- PUBLIC LAW 114–113 – DEC. 18, 2015 – Consolidated Appropriations Act, 2016
- PUBLIC LAW 114–145 – APR. 19, 2016 – Ensuring Patient Access and Effective Drug Enforcement Act of 2016
- PUBLIC LAW 114–198 – JULY 22, 2016 – Comprehensive Addiction and Recovery Act of 2016.
- PUBLIC LAW 114-255 – DEC. 13, 2016 – 21st Century Cures Act
- PUBLIC LAW 114–270 -DEC. 14, 2016 – Expanding Capacity for Health Outcomes Act or the ECHO Act.
- PUBLIC LAW 115-271 – OCT. 24, 2018 – Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act
- PUBLIC LAW 115-334 – DEC 20.2018 – Agriculture Improvement Act of 2018
National Advertising/Marketing Information
- FDA Drug Advertising: A Glossary of Terms
- Office of Prescription Drug Promotion (OPDP) – Regulatory Information
- Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.)
- Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format (Fed Reg 11/21/2023)
- Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers (Dec 2023)
- 21 CFR 202.1 – Prescription-drug advertisements
National Child Safety Information
- Child Abuse Prevention and Treatment Act (CAPTA)
- FDA – Pediatric Safety
- Substance Use During Pregnancy and Child Abuse or Neglect: Summary of State Laws (LAPPA 2022)
National Compounding Information
- FDA – Compounding Laws and Policies
- 21 U.S. Code § 353a – Pharmacy Compounding
- USP Chapter 797 – Pharmaceutical Compounding – Sterile Preparations
National Coroner/Medical Examiner Information
- 10 U.S. Code § 1471 – Forensic pathology investigations
- CDC Coroner and Medical Examiner Laws
- Medical Examiners and/or Coroners are overseen by State laws which vary from state to state.
National Drug Checking Information (Test Strips)
- 21 U.S. Code § 863 – Drug paraphernalia
- CDC – Federal Grantees May Now Use Funds to Purchase Fentanyl Test Strips (April 2021)
- Fentanyl Test Strips – LAPPA 2021
National Drug Cleanup Information (Methamphetamine & Fentanyl Labs)
- EPA – Cleanup Laws, Regulations and Guidance
- EPA – Voluntary Guidelines for Methamphetamine and Fentanyl Laboratory Cleanup
- EPA – Voluntary Guidelines for Methamphetamine and Fentanyl Laboratory Cleanup – Aug 2021
- Fentanyl Cleanup – LAPPA 2021
National Drug Court Information
- Federal Confidentiality Laws and How They Affect Drug Court Practitioners (1999)
- US DOJ – Drug Courts Brief
National Drug Free Workplace Information
- 14 CFR Part 120 Subpart E – Drug Testing Program Requirements
- 41 U.S. Code Chapter 81 – DRUG-FREE WORKPLACE
- US DOL – Drug Free Workplace Act (Oct 16, 1990)
National Drug Violations Information
- U.S. Code: Title 21
- 21 U.S. Code § 841 – Prohibited acts A
- 21 U.S. Code § 841 – Prohibited acts B
- 21 U.S. Code § 843 – Prohibited acts C
- 21 U.S. Code § 844 – Penalties for simple possession
- USDOJ – Frequently Used Federal Drug Statutes
- DEA Guidance Document on Suspicious Orders (Jan 2023)
National Electronic Prescribing Information
- CMS – E-Prescribing
- DEA – Electronic Prescriptions for Controlled Substances (EPCS)
- 21 CFR Part 1306 – Prescriptions
- 21 CFR Part 1311 – Requirements for Electronic Orders and Prescriptions
- Federal Register: Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances Between Pharmacies for Initial Filing (July 27, 2023)
National First Responder Deflection Program(s) Information
- Model Law Enforcement and Other First Responders Deflection Act (LAPPA 2021)
- US DOJ – Pretrial Diversion Program
- US Sentencing Commission – Alternatives to Incarceration and Diversion Programs
National 911 – Good Samaritan Information
- Good Samaritan laws are State laws and vary from state to state.
National Medical Marijuana, Recreational Marijuana & CBD Information
- 7 CFR § 990 – Domestic Hemp Production Program
- 21 U.S. Code § 841 – Prohibited acts A
- 21 U.S. Code § 844 – Penalties for simple possession
- FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)
- US DOJ – Presidential Proclamation on Marijuana Possession (Oct 2022)
- US Office of Personnel Management Memo – Federal Laws and Policies Prohibiting Marijuana Use (May 2015)
National Medication Assisted Treatment (MAT) Information
- H.R.5163 – Telehealth Response for E-prescribing Addiction Therapy Services Act (Intro 8/1/23)
- SB 3193 – TREATS Act – To amend the Controlled Substances Act to allow for the use of telehealth in substance use disorder treatment, and for other purposes. (Intro 11/1/23)
- 42 USC Chapter 1, Subchapter A, Part 8 – Medication Assisted Treatment for Opioid Use Disorders
- Federal Register: Medications for the Treatment of Opioid Use Disorder – Final Rule (Feb 2024)
- Federal Register Notice of Proposed Rule: Expansion of Induction of Buprenorphine via Telemedicine Encounter (March 1, 2023)
- Medications for Substance Use Disorders – Statutes, Regulations, and Guidelines (SAMHSA)
National Naloxone Information
- FDA – Information about Naloxone and Nalmefene
- Naloxone Access: Summary of State Laws (LAPPA 2023)
- Prescription Drug Abuse Policy System (PDAPS) – Naloxone Overdose Prevention Laws
National Needle Exchange Programs (NEP) & Syringe Services programs (SSP) Information
- 42 USC §300ee-5 Use of funds to supply hypodermic needles or syringes for illegal drug use; prohibition.
- CDC – Syringe Service Programs (SSPs)
- Model Syringe Services Program Act (LAPPA 2021)
National Neonatal Abstinence Syndrome (NAS), Neonatal Opioid Withdrawal (NOWS) Information
- 42 USC §247b-13 Perinatal and postnatal health.
- 42 USC §290bb-1 Residential treatment programs for pregnant and postpartum women.
- 42 USC §290ee-2 Building Communities of Recovery.
- PUBLIC LAW 114–198 – JULY 22, 2016 – Comprehensive Addiction and Recovery Act of 2016.
- PUBLIC LAW 114–91 – NOV. 25, 2015 – Protecting Our Infants Act of 2015.
- Substance Use During Pregnancy and Child Abuse or Neglect: summary of State Laws (LAPPA 2022)
- Substance Use During Pregnancy and Child Abuse or Neglect (LAPPA 2024)
- CAPTA CARA is a federal regulation requiring the creation of Plans of Safe Care (POSC) to support the health and safety of newborns affected by substance use and their families or caregivers. The provisions also require states to collect and report data on the number of substance affected newborns born annually. See 42 USC §§5106a(b)(2)(B)(iii) and 5106a(d)(18).
National Opioid Litigation Proceeds Information
- National Opioid Settlement – Distributor Settlement Agreement (Final 3.25.22)
- Opioid Settlement Tracker
National Overdose Prevention Centers (OPC), Supervised Consumption Sites (SCS), Supervised Injection Facilities (SIF) Information
- 21 USC Section 856 – Maintaining drug involved premises
- Overdose Prevention Centers have passed at the State Level in several states such as NY and RI.
National Overdose Surveillance/Reporting Information
- 21 U.S. Code § 379aa – Serious adverse event reporting for nonprescription drugs
- Model Overdose Fatality Review Teams Act (LAPPA)
National Pain Management Information
- 10 USC §1071 Purpose of this chapter.
- 38 USC §7311 Quality assurance.
- 38 USC §7327 Centers for research, education, and clinical activities on complex multi-trauma associated with combat injuries.
- PUBLIC LAW 114–145 – APR. 19, 2016 – Ensuring Patient Access and Effective Drug Enforcement Act of 2016
National Pill Press & Counterfeit Medication Information
- Summary Brief – DEA 2017
- Ontario Pending Action(s) – Bill 126, Illegal Pill Press Act, 2017 – Bill text
- 21 U.S. Code § 830 – Regulation of listed chemicals and certain machines
- 21 U.S. Code § 881(a) – Forfeitures
- 21 CFR § 1310.05(b) – Reports.
- Pill Press Laws: A forgotten Aspect of Counterfeit Drug-Making (LAPPA 2021)
- Pill Press Laws: A forgotten Aspect of Counterfeit Drug Making (Update 2024)
National Prescription Drug Drop-Off Information
- PUBLIC LAW 111–273 – OCT. 12, 2010 – Secure and Responsible Drug Disposal Act Of 2010.
- 21 CFR Part 1317 – Disposal
National Prescription Drug Importation Information
- 21 U.S. Code § 384 – Importation of prescription drugs
- FDA – Human Drug Imports
- Importation of Prescription Drugs Final Rule Questions and Answers; Guidance for Industry: Small Entity Compliance Guide; Availability (May 2022)
- Several legal initiatives have been made at the State Level in several states such as FL, CO, TX.
National Prescription Drug Monitoring Program Information
- 42 USC §290ee Opioid overdose reversal medication access and education grant programs.
National Precursor Chemicals/Including Pseudoephedrine Information
- 6 USC §220 Methamphetamine and methamphetamine precursor chemicals.
- 21 USC §802 Definitions.
- 21 USC §814 Removal of exemption of certain drugs.
- 21 USC §826 Production quotas for controlled substances.
- 21 USC §830 – Regulation of listed chemicals and certain machines.
- 21 USC §842 – Prohibited acts B.
- 21 USC §844 – Penalties for simple possession.
- 21 USC §952 – Importation of controlled substances.
- 21 USC §971 – Notification, suspension of shipment, and penalties with respect to importation and exportation of listed chemicals.
- 22 USC §2291 – Policy, general authorities, coordination, foreign police actions, definitions, and other provisions.
- 22 USC §2291h – Reporting requirements.
- 22 USC 2291j – Annual certification procedures.
- PUBLIC LAW 104–237 – OCT. 3, 1996 – Comprehensive Methamphetamine Control Act of 1996.
- PUBLIC LAW 110-143 – DEC. 21, 2007 – Methamphetamine Remediation Act of 2007.
- Methamphetamine and Precursors: Summary of State Laws (2024)
National Prison/Jail Program(s) Information
- 42 U.S. Code § 250 – Medical care and treatment of Federal prisoners
- Jail-Based Medication-Assisted Treatment
- Managing Substance Withdrawal in Jails: A Legal Brief (BJA 2022)
National School Programs/Information
- 34 CFR §86 – Drug and Alcohol Abuse Prevention
- School Naloxone access is regulated by state. There is no federal standing order authorizing access to naloxone in schools.
- S.2946 – School Access to Naloxone Act of 2023
- Fentanyl and Opioids: Preventing Overdoses and Related Emergencies at K-12 and Higher Education Campuses – Fact Sheet
National Sober Living Homes/Recovery Residence Information
- Best Practices for Recovery Housing (SAMHSA 2023)
- Recovery Housing: Best Practices and Suggested Guidelines (SAMHSA)
- Sober Living Homes and Recovery Residence laws are State laws and vary from state to state.
National Substance Abuse Services Information
- 10 USC §1142 – Preseparation counseling; transmittal of medical records to Department of Veterans Affairs
- 38 USC §1701 – Veteran’s Benefits.
- 38 USC §1706 – Management of health care: other requirements.
- 38 USC §1720A – Treatment and rehabilitative services for persons with drug or alcohol dependency.
- 42 USC §290bb-1 – Residential treatment programs for pregnant and postpartum women.
- 42 USC §290bb-10 – Evidence-based prescription opioid and heroin treatment and interventions demonstration.
- 42 USC §290bb-36d – Treatment Referral Routing Service.
- CMS-4140-F: Final Rules – Mental Health Parity and Addiction Equity Act of 2003
- Fact Sheet 42 CFR Part 2 Final Rule – Confidentiality provisions
National Telemedicine/Telehealth Information
- 42 CFR Chapter IV, Subchapter B, Part 410 § 410.78 – Telehealth services
- Federal Register Notice of Proposed Rule: Expansion of Induction of Buprenorphine via Telemedicine Encounter (March 1, 2023)
- Federal Register Notice of Proposed Rule: Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In- Person Medical Evaluation (March 1, 2023)
- Federal Register Notice Temporary Extension of COVID–19 Telemedicine Flexibilities for Prescription of Controlled Medications (May 10, 2023)
- National Health Council – Updates on Telehealth Legislation
- Telehealth Policy (HHS)
- US Department of HHS – HHS Fact Sheet: Telehealth Flexibilities and Resources and the COVID-19 Public Health Emergency
- Telehealth regulations can be complex and vary from state to state.
National Tribal & Tribal Opioid Response (TOR) Information
- Federal Register: Tribal Opioid Response (TOR) Consultation (October 4, 2023)
- BIA – Tribal Opioid Response
Last Update 10/20/2024
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