The Food and Drug Act of 1906, also known as the Wiley Act prohibited interstate commerce of adulterated or misbranded food, drinks and drugs. Government approval of drugs became required.
In response to the fatal poisoning of 107 people, mostly children, by an untested for safety sulfanilamide liquid, new drugs and drug formulations required to be shown as safe before marketing under this act. Sulfanilamide was a drug used in tablet and powder formulations for streptococcal infections. In 1937 in response to a demand, S.E. Massengill Co. in Bristol, TN created a liquid formulation that passed flavor, appearance and fragrance tests. The elixir was never tested for safety and the vehicle used, diethylene glycol, was toxic and a deadly poison.
This law defines what drug requires a prescription from a licensed
practitioner and also the inclusion on the label "Caution: Federal Law prohibits
dispensing without a prescription."
This amendment requires drug manufacturers to require proof of both safety
and effectiveness before marketing a drug. This came about as a result of the birth defects associated with the use of thalidomide
This act required child-resistant packaging on many prescription, otc and household products. It was developed to address the alarming number of accidental poisonings of young children. It is regulated through the Consumer Product Safety Commission.
The CSA established the DEA as a division of the Department of Justice and also classified five levels of controlled substances.
U.S.C. TITLE 18 - CRIMES AND CRIMINAL PROCEDURE PART I - CRIMES CHAPTER 65 - MALICIOUS MISCHIEF
§ 1365. Tampering with consumer products
This Act prohibited the knowingly selling, purchasing, or trading, or offering to sell, purchase, or trade a prescription drug sample.
This act required pharmacists to offer counseling to Medicaid patients when dispensing prescription drugs.
This rule mandated that all drugs have pediatric dosing and safety information on their labels if the drug has potential use for pediatric patients
Dietary supplement manufacturers must register their facilities with the FDA. They are not required to get FDA approval before producing or selling dietary supplements. Manufacturers and distributors must make sure that all claims and information on the product label and in other labeling are truthful and not misleading.
This act defined which patient information could be shared without the patient’s consent. It provided the regulation to protect patients’ right to privacy.
This act removed the requirement that prescription drugs be labeled with “Caution: Federal law prohibits dispensing without prescription” and adding in its place a requirement that prescription drugs be labeled with “Rx only”.
The Drug Addiction Treatment Act of 2000 (DATA 2000) expands the
clinical context of medication-assisted opioid addiction treatment by allowing
qualified physicians to dispense or prescribe specifically approved Schedule III,
IV, and V narcotic medications for the treatment of opioid addiction in treatment
settings other than the traditional Opioid Treatment Program (i.e., methadone
clinic). In addition, DATA 2000 reduces the regulatory burden on physicians
who choose to practice opioid addiction therapy by permitting qualified
physicians to apply for and receive waivers of the special registration
requirements defined in the Controlled Substances Act.
Every registered pharmacy is required to post the Don’t Flush Notice under New York's Drug Management and Disposal Act effective March 24, 2009.
Restricted access to retail sale of dextromethorphan, commonly known as "dxm"
The 2003 Medicare Prescription Drug Improvement and Modernization Act provided a drug benefit program to senior citizens known as Medicare Part D.
Mental Health Law 9.46 requires mental health professionals to report to their local director of community services ("DCS") or his/her designees when, in their reasonable professional judgment, one of their patients is "likely to engage in conduct that would result in serious harm to self or others." The reporting requirement extends to "mental health professionals," defined in the law as four professions – physicians (including psychiatrists), psychologists, registered nurses, or licensed clinical social workers.
Drug Quality and Security Act 2013
The Compassionate Care Act was enacted in July 2014 to implement the medical marijuana program.
Under the Drug Supply Chain Security Act pharmacies shall only accept drug products from authorized trading partners. Also, pharmacies are required to have processes in place to identify, quarantine, and investigate suspect products and determine whether products are illegitimate. Pharmacies must be able to capture and maintain transaction information (TI), transaction history (TH), and a transaction statement (TS)—sometimes referred to as “the three Ts”—for each drug product received for 6 years from the date of the transaction. The Drug Supply Chain Security Act (DSCSA) was enacted in 2013. Prior to March 1, 2016, the FDA did not intend to take action against dispensers who did not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act.
The Medicare Access and CHIP Authorization Act of 2015 (MACRA) will require all pharmacy claims for Medicare Part D to include a valid Type 1 National Provider Identifier (NPI). This becomes effective January 1, 2016.