PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Controlled Substances Act”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 19 recordsLinked to original sources
PubMed2006

Abuse deterrent formulations and the Controlled Substances Act (CSA).

The Controlled Substances Act (CSA) has reduced the diversion of controlled substances at the manufacturing and distribution levels. Recent increased diversion has occurred at the retail level. Levels of diversion and abuse of controlled substances with similar abuse potential and therapeutic indications often parallel availability for medical use, while rates of diversion and abuse may be influenced by factors related to specific products, including their formulations and risk management plans. Abuse deterrent formulations may reduce abuse and attendant adverse health consequences even if the products are diverted. Their development should consider how, to what extent and by whom products containing the targeted substance are abused. It should take into consideration all potential types of abuse including "as is", multiple doses, alternate routes of administration, physical or chemical separation of the active ingredient, compromised extended release mechanisms and abuse in combination with other substances. Industry incentives for developing abuse-resistant formulations include enhanced corporate image and potentially less restrictive scheduling or risk management plans. Scheduling is substance specific, but the CSA includes products/formulations that are differentially scheduled. Issues to be considered for differential scheduling under the CSA include: (1) whether there is legal authority to do so; (2) application of standard scheduling criteria to individual products; (3) product specific data for "eight factor analyses"; (4) development of predictive data and standards accepted by the scientific and regulatory communities; (5) use of predictive data or post marketing surveillance data; (6) international treaty obligations. These issues must be addressed before differential scheduling can be considered.

Chemistry, Pharmaceutical↗
PubMed1991

Environmental hazard and risk assessment under the United States Toxic Substances Control Act.

The Toxic Substances Control Act (TSCA) was enacted in 1976 and provides for the regulation of industrial chemicals. TSCA allows for regulation of a chemical if there is an unreasonable risk towards human health or the environment, and it allows for testing if a chemical may present an unreasonable risk or has significant exposure towards humans or the environment. Risk assessment under TSCA consists of the integration of the hazard assessment for a chemical with the chemical's exposure assessment. The environmental hazard assessment consists of identifying all of the effects of a chemical towards organisms in the environment, and towards the populations, communities, and ecosystems to which those organisms belong. Toxicity data for a chemical consists of effective concentrations (EC) which indicate the type of effect and the seriousness of that effect at a known concentration of chemical. Effective concentrations are either measured or predicted using structure activity relationships (SAR). SAR may consist of nearest analog analysis, member of a toxic chemical class, or quantitative SAR (QSAR). A collection of all of the ECs for a chemical is called a hazard profile or a toxicity profile. The environmental exposure assessment consists of measuring or predicting the environmental concentrations of a chemical from releases due to its production, processing, uses, and disposal. There are two types of exposure assessment most frequently used under TSCA: the Percentile Stream Flow Method and the Probability Dilution Model (PDM) Method. Environmental risk assessment under TSCA is performed by using the quotient method. This method simply compares an EC with the actual or predicted environmental concentrations (PEC). If the PEC is greater than the EC, then you have a potential risk. The risk assessment process usually consists of three steps: (i) worst case risk assessment, (ii) identification of the type or risk (e.g., acute and/or chronic risk), and (iii) quantification of the degree of environmental risk or the potential environmental impact expected for each type of risk. If the risk assessment determines that a chemical presents a potential risk to the environment, then the results of this assessment are integrated with the economic assessment, any relative risk factors, and governmental policy in order to decide whether a chemical may present an unreasonable risk to the environment.

Animals↗
PubMed2004

The global political economy of scheduling: the international-historical context of the Controlled Substances Act.

This article explains the international context of regulation to control addicting substances that gave rise to schedules. It discusses the impact of scheduling decisions on subsequent national drug control legislation and international drug control negotiations, highlighting how the creation of schedules introduced new incentives and rewards into calculations about the national/international commerce in drugs. In particular, the schedules affected the development and clinical application of psychotropic substances, and the 1971 Convention on Psychotropic Substances receives special focus. The roles of governmental representatives, pharmaceutical company interests, medical researchers, physicians, and pharmacists are highlighted. The article illustrates how debates about scheduling in international treaties over the previous 40 years impacted the creation of the 1970 Controlled Substances Act in the United States and how the constituencies that contributed to constructing the Controlled Substances Act viewed their efforts in a global context.

Drug and Narcotic Control↗
PubMed1987

Application of the preliminary developmental toxicity screen for chemical hazard identification under the Toxic Substances Control Act.

The Office of Toxic Substances (OTS) within the U.S. Environmental Protection Agency (EPA) is authorized to carry forth the mandates of the Toxic Substances Control Act (TSCA). Included among the provisions of TSCA are the development of requirements for testing of "new" and "existing" chemicals that may present an unreasonable risk of injury to health or the environment. There are over 63,000 "existing" chemicals on the TSCA inventory, and EPA in recent years has been receiving an average of over 1,300 submissions for "new" chemicals a year. Since it is illogical and unrealistic to expect that all of these chemicals should be subjected to detailed testing for all potential adverse health and environmental effects, OTS views screening assays as highly useful tools to assign priorities to chemicals for further testing according to standard methodologies. The Chernoff/Kavlock assay (preliminary developmental toxicity screen) was specifically developed to address the need for a developmental toxicity assay to prioritize for further testing the large number of "new" and "existing" chemicals. OTS has been involved in seeking the development of data through the preliminary developmental toxicity screen for purposes of validating the screen and to obtain critical data necessary for evaluating chemicals. OTS believes that the screen has a role in the risk assessment process and has developed a testing protocol, which is included along with other OTS test guidelines; has provided internal guidance on when the screen may be recommended; and has discussed how the data may be applied in prioritizing chemicals for further study.

Animals↗
PubMed2004

The Controlled Substances Act: how a "big tent" reform became a punitive drug law.

The 1970 Controlled Substances Act was part of an omnibus reform package designed to rationalize, and in some respects to liberalize, American drug policy. While the legislation provided additional resources for law enforcement and a systematic means for regulating the use of most psychoactive drugs, it also did away with mandatory minimum sentences and provided more support for treatment and research. Over the next three decades, and in response to public alarm about drug abuse, the US Congress continuously amended the law to produce a more punitive system of drug control. The amendments, which gave the Drug Enforcement Administration greater control over scheduling and maintenance and which substantially increased penalties for illicit trafficking, transformed the law into the legal foundation of America's "drug war," as the stricter criminal approach came to be known. By the 1980s, the flexibility and innovative spirit of the original Controlled Substances Act (and that of Nixon-era drug strategy generally) had largely disappeared from American drug policy.

Drug and Narcotic Control↗
PubMed2002

Reinterpreting the controlled substances act: predictions for the effect on pain relief.

On November 6, 2001 U.S. Attorney General Ashcroft reinterpreted the Controlled Substances Act in a manner consistent with the Pain Relief Promotion Act, a bill introduced in the last Congress. This reinterpretation criminalizes actions related to the provision of controlled substances (e.g. opioids, barbiturates) in the event that a patient dies and external observers believe the intent of providing the medication was to hasten the patient's death. This paper analyzes the arguments regarding the need for reinterpretation and the potential consequences of such an action on pain relief. The conclusion is that the weight of the data clearly leads to the prediction that this reinterpretation of the Controlled Substances Act will lead physicians to be less likely to provide adequate types and doses of pain medication to patients who may die.

Drug and Narcotic Control↗
PubMed2004

Debating the Controlled Substances Act.

In the United States, the basis of modern drug regulation is the Controlled Substances Act (CSA) of 1970. The CSA laid out the authority of the federal government and provided a framework within which all existing and new substances could be regulated on their abuse potential, safety, and medical utility. The debates over the CSA centered on several critical issues: where to place the authority to make scheduling designations, the impact of scheduling on drug research, and defining what constituted drug "abuse" for purposes of scheduling. Passage of the CSA was aided by broad language that provided a kind of "big tent" which could accommodate diverse points of view. A retrospective assessment of the CSA shows it to have greatly expanded federal administrative authority over the nation's drug supply, much as its authors intended. Other impacts of the CSA, however, are much less certain. This article concludes by highlighting the issues and questions that should guide future retrospective research on the efficacy of drug control regimes.

Drug and Narcotic Control↗
PubMed2002

Oregon versus Ashcroft: pain relief, physician-assisted suicide, and the Controlled Substances Act.

OBJECTIVE: Late in 2001, the State of Oregon filed suit against Attorney General John Ashcroft, seeking to halt his recent directive that physicians who comply with the Oregon Death with Dignity Act by writing a lethal prescription for a controlled substance should be prosecuted for violating the federal Controlled Substances Act (CSA). This special article reviews the history of the series of challenges to the Oregon Act since its initial adoption in 1994, with particular consideration of the arguments on both sides of Oregon v. Ashcroft and the disposition of the case by the district court. DESIGN: The article utilizes an historical review of the Oregon Act, including legal and political challenges to it, as well as discussion of the 3 years of data on the experience with legalized physician-assisted suicide in Oregon, and analysis of the legal issues in the current litigation. CONCLUSIONS: The federal district court concluded that the Attorney General's interpretation of certain provisions of the CSA so as to preclude the writing of a lethal prescription where otherwise permitted by state law as a legitimate medical practice was inconsistent with the CSA and, therefore, beyond the scope of his authority. The Oregon Act will continue in force while the Attorney General's appeal of the district court ruling is considered by the Ninth Circuit Court of Appeals.

Analgesics, Opioid↗
PubMed2000

Placement of gamma-butyrolactone in List I of the Controlled Substances Act (21 U.S.C. 802(34)). Drug Enforcement Administration, Justice. Final rule.

Public Law 106-172, signed into law on February 18, 2000, and known as the "Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 1999," amends section 102(34) of the Controlled Substances Act as amended (CSA) by designating gamma-butyrolactone (GBL), the precursor to gamma-hydroxybutyric acid (GHB), as a List I chemical. Reflecting this change in stature, the Drug Enforcement Administration (DEA) is amending its regulation to reflect the status of GBL as a List I chemical subject to the requirements of the CSA and its regulations. Establishment of a threshold for GBL will be the subject of a separate rulemaking. Therefore, unless and until a threshold is established, any distribution of GBL is a regulated transaction as described by 21 CFR 1300.02(b)(28). All handlers of GBL must comply with the CSA regulatory requirements pertaining to List I chemicals as described in the body of this document.

4-Butyrolactone↗
PubMed2003

A dissent from the many dissents from Attorney General Ashcroft's interpretation of the Controlled Substances Act.

In this essay, Professor Marc Spindelman examines the states' rights arguments that have been deployed in the Oregon v. Ashcroft litigation to challenge Attorney General John Ashcroft's interpretation of the federal Controlled Substances Act. Professor Spindelman criticizes those arguments as reflecting bad politics--politics of complicity--that self-styled liberals should resist and reject.

Drug and Narcotic Control↗
PubMed2002

Field testing of particulate matter continuous emission monitors at the DOE Oak Ridge TSCA incinerator. Toxic Substances Control Act.

A field study to evaluate the performance of three commercially available particulate matter (PM) continuous emission monitors (CEMs) was conducted in 1999-2000 at the US Department of Energy (DOE) Toxic Substances Control Act (TSCA) Incinerator. This study offers unique features that are believed to enhance the collective US experience with PM CEMs. The TSCA Incinerator is permitted to treat PCB-contaminated RCRA hazardous low-level radioactive wastes. The air pollution control system utilizes MACT control technology and is comprised of a rapid quench, venturi scrubber, packed bed scrubber, and two ionizing wet scrubbers in series, which create a saturated flue gas that must be conditioned by the CEMs prior to measurement. The incinerator routinely treats a wide variety of wastes including high and low BTU organic liquids, aqueous, and solid wastes. The various possible combinations for treating liquid and solid wastes may present a challenge in establishing a single, acceptable correlation relationship for individual CEMs. The effect of low-level radioactive material present in the waste is a unique site-specific factor not evaluated in previous tests. The three systems chosen for evaluation were two beta gauge devices and a light scattering device. The performance of the CEMs was evaluated using the requirements in draft Environmental Protection Agency (EPA) Performance Specification 11 (PS11) and Procedure 2. The results of Reference Method 5i stack tests for establishing statistical correlations between the reference method data and the CEMs responses are discussed.

Environmental Monitoring↗
PubMed2004

Schedules of controlled substances: placement of alpha-methyltryptamine and 5-methoxy-N,N-diisopropyltryptamine into schedule I of the Controlled Substances Act. Final rule.

This final rulemaking is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place alpha-methyltryptamine (AMT) and 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT) into Schedule I of the Controlled Substances Act (CSA). This action by the DEA Deputy Administrator is based on a scheduling recommendation by the Department of Health and Human Services (DHHS) and a DEA review indicating that AMT and 5-MeO-DIPT meet the criteria for placement in Schedule I of the CSA. This final rule will continue to impose the regulatory controls and criminal sanctions of Schedule I substances on the manufacture, distribution, and possession of AMT and 5-MeO-DIPT.

Drug and Narcotic Control↗
PubMed2004

Schedules of controlled substances; placement of 2,5-dimethoxy-4-(n)-propylthiophenethylamine and N-benzylpiperazine into Schedule I of the Controlled Substances Act. Final rule.

This final rulemaking is issued by the Acting Deputy Administrator of the Drug Enforcement Administration (DEA) to place 2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) and N-benzylpiperazine (BZP) into Schedule I of the Controlled Substances Act (CSA). This action by the DEA Acting Deputy Administrator is based on a scheduling recommendation by the Department of Health and Human Services (DHHS) and a DEA review indicating that 2C-T-7 and BZP meet the criteria for placement in Schedule I of the CSA. This final rule will continue to impose the regulatory controls and criminal sanctions of Schedule I substances on the manufacture, distribution, and possession of 2C-T-7 and BZP.

Amphetamines↗
PubMed1992

Pushing the environmental regulatory focus a step back: controlling the introduction of new chemicals under the Toxic Substances Control Act.

Environmental destruction and its attendant effects on the animal world, including human beings, has moved to the forefront of United States and worldwide policy. The effect of this deterioration on human health is unclear. Much debate focuses on the cases of cancer, along with other diseases, that are environmentally induced. Congress has responded with various environmental laws. These laws focus primarily on controlling chemicals placed into the environment, largely by industry. This Note proposes that such a singular focus is inadequate and ultimately costly. A more sensible and efficient strategy to environmental protection places emphasis on controlling inputs to the productive process before the need arises to contain such substances. The Toxic Substances Control Act of 1976 ("TSCA") takes this approach. This Note reviews the means by which TSCA attempted to accomplish its goals and concludes that TSCA's implementation has largely been ineffective. The Note then discusses three possible explanations for TSCA's failure. Finally, the Note proposes how TSCA might be made more effective in regulating new chemicals.

Air Pollution↗