Introduction to Law and Policy {} Federal Law

Pre-'38 Drugs

-Thyroid hormone -Morphine -Codeine -Nitroglycerin

•Test small part of a batch for quality •Applies to manufacturers •Only applies to pharmacies if registered as an outsourcing facility or engage in activities deemed as manufacturers •Manufacturers inspected by FDA every 2 years

Current Good Manufacturing Practice

•Used by generic manufacturers to show proof of bioequivalence and proof of acceptable manufacturing practices

ANDA

Agencies are given authority by statute to create rules and regulations​ •FDA: Food, Drug, and Cosmetic Act​ •IN Board of Pharmacy: Indiana Code, Title 25​ •Enforcement of statute, rules, and regulations are also given by statute to agencies

Administrative law

can be a drug AND a cosmetic -Medicated shampoos

Article

•Third, "unofficial" class •Proposals or state-specific

Behing the counter

•Least dangerous •Do not support life, sustain life, or present with an unreasonable risk of illness or injury with use •Subject to "general controls" -Must conform with cGMP •Stethoscope, scissors, toothbrushes, ventilator tubing

Class I devices

•More "dangerous" than class I •Require special controls -Performance standards set by experts -Most likely to require premarket notification •Syringes, tampons, condoms, HbA1c immunoassay

Class II devices

•Most serious/"dangerous" •Support life, sustain life, prevent the impairment of human health, or present unreasonable risk of illness or injury •REQUIRE pre-market approval -Similar to new drug •Pacemakers, replacement heart valves, implanted spinal cord stimulators

Class III Devices

•Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applies to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, AND articles intended for use as a component of any such articles -Except that such term shall not include soap

Cosmetic

•Set of regulations that establish minimum requirements for: -Methods, facilities, or controls used in the manufacture, packaging, or holding of a drug product

Current Good Manufacturing Practice

•Effectiveness had to be proven or removed from market safe but not known to be effective

DESI drugs

•Instrument or related article that is: 1.Recognized in USP, NF, or any supplement AND 2.Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in man or other animal, AND 3.Intended to affect the structure or any function of the body in man or other animal, and which does not achieve its primary intended purposes through chemical action and which is not dependent upon being metabolized for the achievement of its intended purpose

Device

•FDA can request, but not order •FDA files a lawsuit if manufacturer refuses -"Libel for Information and Condemnation" •Government seizes drug if it wins the suit

Drug recall

•Created prescription and over-the counter classes* •Caution: Federal law prohibits dispensing without a prescription" •Authorized oral prescriptions and refills of prescription medications

Durham-Humphrey Amendment of 1951

Started FDA approval pathway to make sure its safe

Food, Drug, and Cosmetic Act (FDCA) of 1938

•must publish draft rules in The Federal Register •Public comment period & agency review​

Federal rules/regulation creation

Promulgation

Final rules are also published in The Federal Register and Code of Federal Regulations​

1.Articles used for food or drink for man or other animals 2.Chewing gum 3.Articles used for components of articles in 1 and 2

Food

•No new drug could be marketed until proven safe for use described on the label and approved by the FDA •Expanded definitions of adulteration and misbranding •Labels must include "adequate directions for use" and warnings about habit-forming potential of certain medications •Exempted drugs marketed before 1938 to be proven safe •Added cosmetics and devices

Food, Drug, and Cosmetic Act (FDCA) of 1938

•Application sent to FDA •Exemption to NDA in order to investigate and conduct clinical trials on the new drug •Notice of Claimed Exception for an Investigational New Drug •Launching point for clinical trials

IND

stare decisis​

Judicial ruling is enforceable as law and binding on lower courts

•Drugs must be proven safe AND effective •FDA given jurisdiction over prescription drug advertising •Established Good Manufacturing Practices (GMP) •Informed consent of research subjects and reporting of adverse drug reactions in clinical trials

Kefauver-Harris Amendment of 1962

Classification of devices premarket approval performance standards GMP regulations Record and reporting requirements

Medical Device Amendments of 1976

•Application sent to FDA once clinical trials and data collected •Required to approve drug for marketing

NDA

•Outline of what WILL or WILL NOT be done​

Policy

Have never been approved by FDA

Pre-38 drugs

•Widespread food and medication issues •Concern for unsanitary and poorly labeled foods and drugs •Prohibited adulteration and misbranding of foods and drugs in interstate commerce -DID NOT include that misbranding includes false or misleading efficacy claims

Pure Food and Drug Act of 1906

•Public comment period needed​ •Comments reviewed before final rules established​ •Example: pharmacy technician vaccine administration

State rule/regulations

•Passed by US Congress​ •United States Code (USC)​ •Passed by state legislature​ •Indiana Code (IC)

Statutory law

•It must be based on statute that gives the agency authority to promulgate the rule​ •It must have a relationship to public health, safety, and welfare.

Validity of regulations

•Rule/regulation MUST be within the scope of the agency​

Validity of regulations

•A drug is considered ________________, even if it is pure when: -Prepared, packaged, or held in conditions where it MAY have been contaminated -Exposed to a container that MAY have contaminated it -Manufactured under conditions that do not conform to CGMP

adulterated

storrage, mixing or cleaning tray fuc1k ups are

adulteration

•Claims to be official drug and strength, quality, purity different from the compendium standards -UNLESS plainly stated on the label (e.g. "Not USP") •Not an official drug and the strength or purity falls below what is claimed •Mixed or packed with a substance to reduce its quality or strength or complete substitution (entire drug or parts of it)

adulteration

•Entire product or part is filthy, putrid, decomposed •Prepared, packed, held under unsanitary conditions •Methods used, facilities, and controls used for manufacture, processing, packaging, or holding do not conform to Current Good Manufacturing Practice (CGMP) •Container is an issue (poisonous or deleterious) •Contains unsafe coloring agent or is an unsafe coloring agent

adulteration

label requirements to avoid misbranding

established name name and quantity of each active ingradient inactive ingredients brand name if applicable directions warnings against conditions or children packaged and labeled according to compendia caution for deterioration name and address of manufacturer/distributor

•Is the product intended to deliver drugs to the patient, but is not prefilled by the manufacturer? •Is the drug component included solely to make the product safer?

device

mandatroy recalls are for voluntary recalls are for

devices drugs

•Product (other than tobacco) intended to supplement the diet that contains one or more of the following: A.Vitamin B.Mineral C.Herb or other botanical D.Amino acid E.Dietary substance for use by man to supplement the diet by increasing the total dietary intake OR -Concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause A through E

dietary supplement

State agencies must also publish

draft rules

•Display of written, printed, or graphic matter upon the immediate container of any article

label

all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers OR accompanying an article

labeling

the system of rules which a particular country or community recognizes as regulating the actions of its members and which it may enforce by the imposition of penalties

law

•Drug that has false or misleading labeling

misbranding

•Issues with the words associated with the product •Prescription label requirements fall under misbranding •Products can be adulterated AND misbranded

misbranding

•Misleading container or limitations or sold under the name of another drug •Dangerous to health when used in the dose, frequency, or duration described on label

misbranding

•Packaging or labeling in violation of Poison Prevention Packaging Act •Color additive for coloring only and not labeled as such •Failure to comply with REMS •Fails to bear product identifier (Rx-only) •Drug comes from non-registered establishment

misbranding

•Drugs for Rare Diseases •Used for a condition that: -Affects less than 200,000 people in the US OR -Affects more than 200,000 people but the cost of developing and making the drug will not be covered from sales

orphan drug

Preemptive Doctrine

•Federal law preempts state law, unless state law is stricter​ •Follow the stricter law when federal and state law conflict​

Pharmacy Policy Issues

•Opioid crisis​ •Pharmacy provider status​ •COVID-19 response

•Safe and effective for use without supervision

•Over-the-counter (OTC)