Federal: Acts & Amendments Flashcards
Pure Food and Drug Act of 1906
Prohibited foods and drugs distributed through interstate commerce to be adulterated or misbranded
Food, Drug and Cosmetic Act of 1938
*sulfanilamide
- Can’t market a drug until it is SAFE for use of conditions described under label
- Label must contain adequate directions for use and state drugs may be addictive
- Prohibits adulteration and misbranding of drugs
-Adulteration: related to a drug’s strength, purity, and quality; Misbranding: related to the representations made on the label or labeling - Created the Food and Drug Administration (FDA)
Durham-Humphrey Amendment 1951
Created two different classes of drugs: prescription and OTC
- Placed “federal law prohibits dispensing without a prescription” on label or adequate instructions for use
- Established a beyond-use date of no more than 1 year from date Rx dispensed
- Prescribers can transmit prescriptions in writing or ORALLY (by phone)
- Prescribers can authorize refills
Kefauver-Harris Amendment 1962
*thalidomide
- Drugs must be BOTH safe and effective
- Established current good manufacturing practices (CGMP)
- Drug advertising became the responsibility of the FDA (not FTC) - required accurate information about both safety and efficacy
- Created informed consent for research subjects
- Required adverse effect reporting to FDA
Medical Devices Amendment of 1976
Provides classification of medical devices according to function, establishment of performance standards, pre-market approval requirements, GMP standards, requirements to adherence to record and reporting requirements
Orphan Drug Act of 1983
Provides tax incentives to drug manufacturers to develop medications that treat rare disease or conditions affecting fewer than 200,000 Americans
Drug Price Competition and Patent Term Restoration Act of 1994
- Initial patent for drugs is 20 years from the date the patent is granted (which is usually during IND/phase I studies)
- Brand drugs 🡪 receive 5 years of exclusivity from approval and an additional 3 years if new use developed
- Created the Abbreviated New Drug Application (ANDA) for generic medications that required them to just be proven bioequivalent (+/- 20% of rate/extent of absorption) instead of efficacy and safety + 180 days market exclusivity (Medicare provision)
Prescription Drug Marketing Act 1987
- Required drug wholesalers to be licensed with a distributor license
- Banned re-importation of drugs by anyone but the manufacturer
- Banned the sale, trade, and purchase of medication samples and required drug reps to keep records on their distribution for 3 years
-A pharmacy cannot distribute samples unless it is a hospital pharmacy where practitioner authorizes samples (records must be kept) - Specified precise storage, handling, and recordkeeping requirements for drug samples
- Prohibited resale of drugs purchased by hospital
-Require proper storage of drugs and maintenance of appropriate distribution records
-Prohibits shipping drugs between states without registration in the state shipping from
-Prohibits reimportation except by manufacturer
-Requires wholesaler license
-Restricts sale of drug samples, prohibits retail pharmacy from possessing drug samples (considered drug diversion)
-Hospital/clinic pharmacies may receive samples only if prescriber has requested them
-Allows starter packs distributed by pharmacies to patients
-Prohibits resale of drugs by hospitals
-Drug manufacturers keep records of samples for 3 years, sales representatives must take annual inventory of samples
Food and Drug Administration Modernization Act of 1997
- Clarified compounding vs. manufacturing – compounding exempt from GMP and FDA approval process
- Prescription drug legend shortened to “Rx only” and removed habit forming warning
- Requires at least ONE clinical trial for drug approval
- Allows pediatric patients to be treated with drugs for unapproved use
- Created FAST-TRACK APPROVAL to expedite approval of new drugs to treat life-threatening conditions
Patient Protection and Affordable Care Act (Health Care Reform Act) of 2010
- Requires all individuals to have health insurance
- Requires standards for financial and administrative transactions including timely and transparent claims using standard electronic transactions (previously Part D required paid claims within 14 days of electronic submission or 30 days otherwise)
- Stop agreements between brand and generic manufacturers that limit or delay competition
- Elimination of catastrophic threshold (donut hole)
USP/NF
USP contains drug monographs for all recognized drugs, includes standards of quality and chemical characteristics
Pharmacopeia Forum = bimonthly publication of changes
To use USP/NF name drug must meet standards, otherwise = adulterated/misbranded
Drug Supply Chain Security Act (2013)
The Drug Quality and Security Act (DQSA) was enacted in 2013 and contained two titles. Title
I was discussed with compounding, and title II is the Drug Supply Chain Security Act (DSCSA). It
establishes requirements to “achieve interoperable, electronic tracing of products at the package
level to identify and trace certain prescription drugs as they are distributed in the United
States.” This improves manufacturers’, pharmacies’, and the FDA’s ability to identify counterfeit
or contaminated products and prevent those products reaching patients. This law requires
manufacturers and repackagers to add identifiers (e.g., barcodes or QR codes) to certain
prescription product packages. These identifiers help manufacturers and other entities, including
pharmacies, trace and verify purchased products. Suppose a pharmacy or other entity believes
they received an illegitimate product. In that case, they may request verification from the place
they purchased the product (e.g., manufacturer or wholesaler) and receive a verification of the
product within 24 hours. Nonprescription drugs, animal drugs, blood or blood components for
transfusions, radioactive drugs, biologic products, imaging drugs, certain intravenous products,
medical gases, certain homeopathic drugs, and lawfully compounded drugs are not covered by
this act and do not require identifiers.
Similarly, reports and verification of illegitimate products should be brought to the FDA within
24 hours of confirmation. In addition to verification, the identifiers are also expected to help
identify recalled products and assist pharmacists in meeting their duty to patients by preventing
dispensing these recalled products. As part of the tracking process, pharmacies must implement
tracking of specific lot numbers throughout the filling process, so they can track back the exact
product a patient receives. In addition to the requirements to help identify problematic
products in the supply chain and stop their distribution, another central provision of the DSCSA
includes creating a database to look up wholesale drug distributors and third-party logistics
providers. There is currently a proposed rule covering national standards for the licensure of
these entities.
The Omnibus Reconciliation Act of 1990
The Omnibus Reconciliation Act of 1990, more commonly referred to as OBRA ’90, is a large
piece of legislation to ensure taxpayer dollars are spent appropriately and reduce costs. Only a
small portion of the law impacted pharmacy, but the impacts are important to practice. Areas
of the act targeting pharmacy practice focused on drug utilization review with counseling and
patient profiles as part of reviews. The focus of these provisions was Medicaid beneficiaries.
However, states had the opportunity to expand covered individuals if desired, and states could
refuse to adopt requirements but would no longer receive federal money for Medicaid if refusing
to adopt the requirements.
A drug utilization review (DUR) “is an ongoing, systematic process designed to maintain the
appropriate and effective use of medications.”8 There are two main types of DURs – prospective
and retrospective. A prospective DUR is when a pharmacist reviews a prescribed drug therapy
and the patient’s profile and applies their knowledge about proper medication use before
dispensing to “identify and resolve problems before the patient has received the medication.”
While a retrospective DUR is when a patient’s regimen is reviewed after the patient.
Retrospective reviews are completed “to detect patterns in prescribing, dispensing, or
administering drugs.” These reviews can help improve care for individual patients (e.g., identify
missing medications on a regimen or inappropriate medications) or within a target population.
OBRA ’90 required states to establish standards for prospective DURs and required retrospective
DURs to be completed for patients in long-term care facilities (LTCFs).
As part of prospective DURs, OBRA ’90 added counseling and patient profile requirements. It
established that pharmacies are required to maintain patient profiles and other records. This
information was added to the law to help ensure enough information was provided so a
pharmacist could complete a DUR, as noted by the act. Finally, this act required states to
establish standards for when an offer to counsel or counseling is required. Some states
implemented a requirement to offer counseling to patients at dispensing, whereas others
required counseling for new prescriptions. As part of this, states also had to implement
recordkeeping requirements for counseling, like noting when patients accepted or declined the
offer of counseling.
Poison Prevention Packaging Act of 1970
The Poison Prevention Packaging Act (PPPA) of 1970 is essential for pharmacists and future
pharmacists to know. It was enacted in response to the growing issue of child poisonings caused
by common household substances. The Act gives the Consumer Product Safety Commission
(CPSC) the authority to require special packaging of “hazardous substances” as defined by 15 USC
1261. The goal is to prevent accidental poisoning in children under five. That statement is
important – this act is only meant to prevent poisonings in children younger than five, which
means four and under.
The Dietary Supplement Health and Education Act of 1994
Act established the dietary
supplement category of substances. This Act “significantly altered the FDA’s authority to regulate
dietary supplements.” Based on rules in DSHEA, the FDA is forced to treat dietary supplements
more like a type of food instead of a drug. Based on the definition discussed previously in the
definitions section of this text, you may see why dietary supplements align more closely with
foods than drugs.
This Act allows a manufacturer to make claims relating to a dietary supplement’s effect on a
structure or function in the body if the claim falls into any of the four following categories.
1. “Claims a benefit related to a classical nutrient deficiency disease and discloses the
prevalence of such disease in the United States.
2. Describes the role of a nutrient or dietary ingredient intended to affect the structure or
function in humans.
3. Characterizes the documented mechanism by which a nutrient or dietary ingredient acts
to maintain such structure or function.
4. Describes general wellbeing from consumption of a nutrient or dietary ingredient.”
The company must have evidence to support the claim, and the claim cannot be presented
misleadingly. These claims can be made on a product without prior review (e.g., approval) from
the FDA; however, a manufacturer must notify the FDA within 30 days of first marketing the
product.
