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Timeline


Food and Drug Act of 1906

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.


1938 Food, Drug and Cosmetic Act (FDC)

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.


1951 Durham-Humphrey Amendment

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."


1962 Kefauver-Harris Amendments

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


1970 Poison Prevention Packaging Act

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.


1970 Controlled Substance Act

The CSA established the DEA as a division of the Department of Justice and also classified five levels of controlled substances.


Federal Anti-Tampering Act - 1982

U.S.C. TITLE 18 - CRIMES AND CRIMINAL PROCEDURE PART I - CRIMES CHAPTER 65 - MALICIOUS MISCHIEF
§ 1365. Tampering with consumer products

Brief Summary

  • Passed by Congress in 1984 due to deaths from cyanide contamination of Tylenol in 1982
  • The product must be labeled with a statement alerting consumers what the products specific tamper-resistant packaging entails
  • The seal and its properties of the product must not be reproducible by the public


The Prescription Drug Marketing Act of 1988

This Act prohibited the knowingly selling, purchasing, or trading, or offering to sell, purchase, or trade a prescription drug sample.


1990 Omnibus Budget Reconciiatiion Act (OBRA)

This act required pharmacists to offer counseling to Medicaid patients when dispensing prescription drugs.


Pediatric Labeling Rule of 1994

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 Health and Education Act of 1994 (DSHEA)

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.


1996 Health Insurance Portability and Accountability Act (HIPAA)

This act defined which patient information could be shared without the patient’s consent. It provided the regulation to protect patients’ right to privacy.


FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997

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

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.


Combat Methamphetamine Epidemic Act of 2005


New York's Drug Management and Disposal 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.


New York Consolidated Laws GBS - General Business Article 26 - (390 - 399-ZZZ) MISCELLANEOUS

Restricted access to retail sale of dextromethorphan, commonly known as "dxm"


Medicare Prescription Drug Improvement and Modernization Act

The 2003 Medicare Prescription Drug Improvement and Modernization Act provided a drug benefit program to senior citizens known as Medicare Part D.


NY SAFE ACT - New York Secure Ammunition and Firearms Enforcement Act of 2013

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.


DQSA

Drug Quality and Security Act 2013


Compassionate Care Act - 2014

The Compassionate Care Act was enacted in July 2014 to implement the medical marijuana program.


Drug Supply Chain Security Act

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.


Medicare Access and CHIP Authorization Act of 2015

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.


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