Exam I Law for final

medical amendment of 1976 devices

MDA improved FDA's regulatory authority over medical devices intended for human use • Triggered by the health hazards of IUD's (Dalkon Shield) FDA previously had no authority over devices

Are MFR allowed a non CRC?

Manufacturer allowed one package size in non child resistant container, provided: - "This package for households w/o young children" or - "Package not child-resistant"

three ways can change from RX to OTC

Manufacturer can request through a supplemental application to NDA • Manufacturer can petition FDA • FDA- add a monograph or amend an existing monograph

cosmetics and adulteration and misbranding

Manufacturer does not have to conform to GMP's, or even register with the FDA • FDA has jurisdiction, however, over any adulterated or misbranded cosmetics or health hazard

what can OTC be marketed under?

Marketed under NDA, ANDA, or OTC monograph

CNRP CS rxing

May prescribe - Schedule II substances for up to 30 days - Schedule III-V substances for up to 90 days

3 components of REMS

Med guides elements to assure safe use communicaiton plans

what do monographs establish?

Monographs establish the titles, definitions, descriptions, and standards for identity, quality, strength, purity, packaging, stability and labeling for a drug

point of D-H act of 1951

created OTC and RX drugs also authorized oral RX and refills of RX drugs

How does a pharmacist or physician become aware of those drugs exempted from PPPA standards?

federal register

function of admin law judical

function of admin law executive

Lidocaine PPPA OTC

greater than 5mg/PKG

Loperramide PPPA OTC

greater than greater than 0.45mg/single package

who can request a blanket waiver for CRC?

head of houseold or patinet, NOT perscriber

exception. to state laws for BE subsitution?

hospitals where formulary comes into play

disticntion between suppliers and puchasers intended use

supplier does not market it for an indication, but people use it for that indication

what kinds of written documents are reccomended persuant to the PPP act?

telephone for perscriber authorization patient authoirzation of non CRP blanket waivers for family/houseolds for non CRP packaging

number system for NDA

1 New Molecular Entity • 2 Chemical derived from active ingredient already marketed • 3 New dosage form • 4 New combination of two or more compounds not previously marketed together • 5 Already marketed but new manufacturer • 6 Already marketed but a new use

what is each bar code required to have at a minimum?

Each drug product for which the bar code requirement applies must have a bar code that contains, at a minimum, the appropriate National Drug Code (NDC) number

Iron-containing drugs OTC PPPA

Elemental iron of 250 mg or more

Iron-containing dietary suppl. OTC PPPA

Elemental iron of 250 mg/pkg

USPC

Established in 1820 by a group of pharmacists and physicians who established stds for drug potency, quality, composition • Published the USP, now (USP/NF) US pharmacopeal convention ***separate from FDA***

package insert requiremnts

Highlights Section includes Boxed Warnings, Indications and Usage, Dosage and Administration • Also includes Table of Contents, Full Prescribing Information and Patient Counseling Section

package inserts in hospitals requirements

Hospitals and other institutions may provide the insert to the inpatient with each dose Or may provide the insert prior to the administration of the first dose, then once every 30 days thereafter

clincical testing requirements INV

Informed consent of the patient is required for all 3 phases of testing (in writing for phases I and II) • Institutional studies must be approved by the IRB

communication plans REMS

(e.g., direct mailings, professional societies, etc.) to communicate risk and REMS-related information to health care providers

two ways to do tamper evident packaging

- Distinctive by design (i.e., the packaging can not be easily duplicated) or - Use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, trademark, logo, picture)

Unit dose containers BUD theory

- Beyond use date is the earlier of one year from the date of repackaging or the expiration date on the bulk container, unless stability data or the manufacturer's labeling indicates otherwise - However, premised on a mean temperature of 25 degrees and using a material other than PVC

what drugs do not require tamper evident packaging?

- Dermatological - Dentifrice - Insulin - Lozenge

which prevails, state or federal law?

- Federal law prevails over state law if true conflict - State laws can be more stringent and not conflict • Any legislation enacted (fed or state) must be consistent with the constitution

exceptions to PDMA resales

- Hospital purchases from a group purchasing organization or another member hospital - Sales or purchases to/from non-profit affiliates, or between hospitals or health care entities under common control - Emergency sales to community pharmacies to alleviate a temporary shortage - Selling or dispensing prescriptions pursuant to prescription (i..e., outpatient, not retail)

FDAAA 2007

- Mandate labeling changes related to safety - Require clinical trial data reporting/registries - Require post marketing studies to asses risk - Require companies to implement risk evaluation and mitigation strategies ***(REMS)***

PA BUD requiremnts

- PA does not require automatic beyond use date - Only need to put "do not use after" language when the mfgr. expiration date less than 1 year

bar coding requiremenets

- Prescription drug products sold to or used in hospitals - Biological products - OTC drug products that are dispensed pursuant to an order and are packaged or labeled for hospital use, or marketed, promoted, or sold to hospitals

W-H admendments generic changes

- Proof of bioavailability - Proof of bioequivalence

what must pharmacy do with med guides?

- Provide the Medication Guide directly to each patient or patient's agent when the product is dispensed

PDMA 3 pronged attack

- Regulates the distribution of samples - Regulates purchases/re-sales of drugs by hospitals, etc. - Requires wholesalers to be licensed

when is reporting deaths with device required? with serious injury or illness?

- Serious injuries or illness caused by a device within 10 working days to the manufacturer - Device suspected of causing a death to the ***FDA and manufacturer w/in 10 working day**** 10 days SII: MFR only Death: FDA and MFR

Elements to Assure Safe Use (ETASU)

- Special Training and/or certification requirements for prescribers or dispensers - Restricting distribution of the drug - Dispensing a drug based on evidence or documentation of safe use conditions (informed consent, etc). - Patient monitoring (e.g., periodic lab testing) - Use of Patient Registries

risk summary components pregnancy

- Structural abnormalities - Fetal and infant mortality - Impaired physiologic function, and - Alterations to growth • Summary will state if animal or human data was used. If human data was used, the summary will go into greater detail. one sentence summary

optometrist perscribing letters

-Therapeutically certified "T" in license # Glaucoma certified "G" in license # Not certified to prescribe at all "L" in license

componding resustictions

-cannot do without an RX -cannot do with removed drugs -cannot compound with parts of NON fDA approved drugs -need to know each part was made in registered FDA facility -receiving storing or using drug components not determined to meet compendia requiremnts - using commetical scale MFR equiments - Compounding drugs for 3rd parties who resell to individual patients or offering compounded drug products at wholesale to other state licensed persons or commercial entities for resale Compounding drug products that are commercially available in the marketplace • Failure to operate in conformance with applicable state law regulating the practice of pharmacy

definition of device

1) Recognized by USP, NF, or supplement 2) Intended for diagnosis, cure, mitigation, treatment or prevention 3) Affects the structure or function of the body and ***does not achieve its primary intended purpose through a chemical reaction in or on the body***, or required to be metabolized for its primary intended purposes

what statements are allowed by DSHEA?

1. Statements that the product will benefit a classical nutrient deficiency disease, so long as it also discloses the prevalence of the disease in the US - 2. Statements that describe the role of the dietary supplement in affecting the structure or function of the body - 3. Statements that characterize the documented mechanism by which a nutrient or dietary supplement acts to maintain structure or function - 4. Statements describing the general well-being from consumption of a nutrient or dietary ingredient

RX exceptions to PPPA- isosorbide dinitrate

10mg or less

why was the Durham Humphrey Amendment of 1951 enacted?

Drugs not safe w/o medical supervision did not need adequate directions for use to comply but label had to state "Caution-Federal law prohibits dispensing w/o prescription"

Offical compendia requirements related to misbranding and adultering

A drug listed in either USP/NF or the Homeopathic Pharmacopeia must meet all compendial standards or it will be considered adulterated or misbranded • A drug is also misbranded or adulterated if it is not recognized in either compendia, yet purports to be

A vs B in orange book

A is therapeutical equivlance B is documented or potential BE issue

what are GMPs?

A set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product • Generally apply to manufacturers and not to pharmacies, unless large scale compounding or certain repackaging activities

Definition of a drug

A) Recognized by USP, NF, or Homeopathic Pharmacopoeia of the US B) Used in diagnosis, cure, mitigation, treatment or prevention C) Affects the structure or any function of the body D) Component of A, B, or C

what does the second letter in orange book describe?

AP - Injectable aqueous solutions (Parenteral) • AT - Topical products • AO - Injectable Oil solutions • AB - Bioequivalence shown through additional in vitro or in vivo testing BC - Controlled release • BD - Documented bioequivalence problems • BE - Delayed Release (e.g., enteric coated) • BT - Topical products with bioequivalence issues

Waxman-Hatch Amendment

Accelerated approval process for generics • Generic drugs more readily available (no clinical testing-only have to show bioavailable and bio-equivalent) • Patent extensions/market exclusivity to the pioneer drug

what is on the drug facts panel?

Active Ingredients (including dosage unit & quantity/dosage unit) • Purpose • Use(s), Indications • Warnings • Directions • Other info as required by monograph, etc • Inactive ingredients • Questions (Optional) followed by telephone #

clincial conisderations pregnancy section

Addresses situations in which a woman was inadvertently exposed to the drug, any effects the medication will have in labor and delivery, and decisions that clinicians may have to make including: - Dosing adjustments during pregnancy - Adverse reactions unique to pregnancy - Interventions that may be required

Authorization for refilling with different MFR emergency?

Advance authorization is not required in an emergency, but the physician shall be notified by the pharmacist as soon as possible thereafter

what occurs for comittee voting on bills?

After input, committee meets in executive session, where the bill is discussed in detail, and where committee members may offer amendments • A vote is taken on whether to report the Bill to full House or Senate for a full vote • A majority of the committee is required to proceed to a full vote of the House or Senate • Committee report accompanies the bill (legislative intent)

administrative law definition

Agencies created by legislatures to administer substantive law • Legislative, executive, and judicial functions •

data seciton pregnancy

All available drug data and its use in pregnant women (human data takes precedence over animal data) - Types of studies completed - What animals were used - Dosage - Type of adverse events observed (if any) - Relationship between drug exposure in animals and humans (if applicable)

Type of issue with oxycontin

Allegations that Oxycontin was promoted by downplaying its abuse potential • Corporate officers had to pay millions in fines as individuals for ****misbranding offense****

what is accomplished by them requesting supplemnetal NDA?

Allows the manufacturer otc marketing exclusivity - Can create a situation whereby an identical competitor's product is still Rx

KH 1962 investigational components

Also added stronger regulations related to the investigational process for new drugs ***- Required informed consent of research subjects - Required reporting of adverse drug events***

When a prescription drug is dispensed in a special package, would the pharmacist be in violation of the regulations if he or she included a separate non-complying closure with the package?

Although this practice is not prohibited, the CPSC staff discourages the practice in that it is likely to result in the use of non-complying packaging by those who are able to use special packaging without difficulty

May a pharmacist legally use reversible or other types of dual-purpose packaging for dispensing prescription drugs?

Although this type of packaging is not prohibited, the CPSC staff discourages its use because it is likely to result in the use of nonspecial packaging. The potential for children being poisoned thus increases

Amenndment in 1912 to FDCA

Amended in 1912 to prohibit false and fraudulent claims • Fraudulent intent was required which was difficult to prove, why updated again

T optometrist topical agents may RX

Anesthetics; steroids; ocular lubricants; ophthalmic dyes and stains; hyperosmotic agents; autonomic agents; NSAIDS; antiviral; analgesics; antihistamines and mast cell stabilizers

3 categories for supplemental NDA

Any changes in production ranging from synthesis of drug or manufacturing process and most of the labeling of drug (require pre-approval) - Strengthened warnings, dosing information, or certain changes in manufacturing methods (notify the FDA that change being effected) - Minor editorial changes in labeling or container size (simply include in annual report)

how do they vote for a bill?

Any major Bill is debated at length, with amendments frequently offered, Bills are frequently referred back to committee • Bills that are passed (simple majority) are sent to the other body where the committee process begins anew

who can introduce a bill?

Any member of the House or Senate may introduce a bill embodying a proposed law

how to begin human testing for new drugs

Applications require info from animal studies re pharmacological, pharmacokinetic, and toxicological evaluations • Submit experience/qualifications of investigators and outline of proposed clinical studies • Human testing can begin if request not rejected by the FDA w/in 30 days

track and trace applys to?

Applies to manufacturers, wholesalers, repackagers, and dispensers requires them to use standard ID, NDC+ serial number by 2023

transaction statement components

Authorized under the DSCSA • Received the product from a trading partner that is also authorized under the DSCSA • Received the transaction information and statement from the trading partner • Did not knowingly ship a suspect or illegitimate product • Has verification systems in place • Did not provide false transaction information or knowingly alter the transaction history

what drugs can G optometrist perscribe?

Beta blockers • Cholinergic receptor agonists • Adrenergic receptor agonists • Topical carbonic anhydrase inhibitors • Prostaglandin analogs

federal BUD GUIDELINES***

Beyond use date not later than the expiration date on the manufacturer's container or one year from the date the drug is dispensed, whichever is earlier

Unit dose containers BUD reality

Beyond use date not to exceed 6 months, and that the beyond use date not to exceed 25% of the remaining time between the date of repackaging and the expiration date on the unopened original manufacturer's container

what occurs during bill deliberation?

Bill is relegated to appropriate committee • Detailed study of the Bill is made • Public is granted opportunity for input (e.g., Public Hearings)

how much can you import? exceptions?

Can import up to 50 dosage units of controlled substances obtained abroad • 50 dosage unit limit does not apply to CS obtained in the US pursuant to a prescription by a DEA registrant

CNM Rxing and blank requiremnts

Can only prescribe psychotropic drugs after consultation with physician • Prescription blank requires phone #, otherwise similar to CRNP requirements

time and type limits for T optom Rxing

Cannot perscribe beyond 6 month Parenterals - Beta Blockers - Drugs for systemic conditions - Drugs for glaucoma

function of admin law executive

Carry out and administer statutes, executive orders, etc. • Carry out and administer the regulations enacted by the agency itself

RX blanks for CRNP

Certification number of the CRNP • Printed name of CRNP • Signature of the CRNP • DEA number if appropriate • ***Collaborating physician's name not required***

PDMA violations MFR

Civil penalty of NMT $50,000 for each of the first two violations in a 10 year period • Civil penalty of NMT $1,000,000 for each conviction after the second in any 10 year period

product recall class I

Class I - reasonable probability of serious, adverse health consequences or death

product recall class II

Class II - temporary or medically reversible adverse health consequences, but remote probability of serious adverse consequences

product recall class III

Class III - not likely to cause adverse health consequences for example, typo on label

phase II study

Clinical investigations of 100 to 200 patients for effectiveness and relative safety. in population of interest

what gives congress the power to police drug industry

Congress has broad powers under Art I, 8 - "Necessary and Proper" Clause - Commerce Clause

adulteration definition

Consists of any filthy, putrid, or decomposed substance - Prepared, packed or held under unsanitary conditions where it may have been contaminated with filth or rendered injurious to health - Not in conformity with GMPs - Container is composed of any poisonous or deleterious substances which may contaminate the drug - Contains an unsafe color additive - Purports to be a drug in an official compendium and its strength differs, or quality or purity is below the compendial standard, unless difference is plainly stated - Not listed in a compendial standard and its strength differs, or quality or purity is below what is listed - Mixed with any substance which reduces its strength or quality or the drug has been substituted (whole or part)

3 sources of US law

Constitution • Legislative (Statutory) Law • Administrative Agency Law

who is PPPA enforced by?

Consumer Product Safety Comm

how to get approval from FDA to use INV drug?

Contact the manufacturer for approval • If yes, then submit an individual use IND to the FDA (brief clinical hx; proposed tx plan; letter of authorization from mfgr.; informed consent statement; qualifications (CV); FDA form 1571; contact phone/fax • Start treatment in 30 days if not contacted otherwise by the FDA

state laws governing pharmacy

Controlled Substance, Drug Device and Cosmetic Act • Dept. of Health Regulations Title 28, Chapter 25 (select portions) Pennsylvania Pharmacy Act • Pharmacy Regulations (Pennsylvania Code) Title 49, Chapter 27

difference between criminal vs civil vs agency

Criminal prosecution can lead to fine and/or imprisonment • Civil Liability usually results in a monetary settlement to compensate the victim • Administrative Penalty involves an Agency imposing fines, suspensions, revocations, etc

Dietary Supplement Health & Education Act of 1994 (DSHEA)

Defines dietary supplements • Allows manufacturers to make structure function claims that would be illegal under the FDCA • Forces the FDA to regulate dietary supplements more as foods than drugs

what did the med device of 1976 add?

Device classification according to function • Pre-market approval for certain conditions • Establishment of performance standards • Conformance with GMP regulations • Record and reporting requirements

when do approved drugs become "new drugs?

Drug contains a new substance (active ingredient, excipient, carrier, or coating) • New combination of approved drugs • Proportion of ingredients in combination changed • New intended use of the drug • Dosage, method, duration of administration or application is changed

exception to BS subsitution PA

Drug products found by the FDA to have a narrow therapeutic range shall not be considered therapeutically equivalent

unit dose labeling requirements

Established name of the drug • Quantity of active drug in each dosage unit • Expiration Date • Lot or control number • Name & location of mfgr, packer, or dist. • Any statements required by compendia • Number of dosage units contained if more than one dosage, and the strength per dosage unit • "Warning-may be habit forming" if applicable • Controlled Drug Symbol if required by the DEA

Prescription Drug Marketing Act of 1987

Establishes sales restrictions and recordkeeping requirements for drug samples • Prevents hospitals and other non-profits entities from reselling purchased drugs • Requires the state licensing of drug wholesalers

cranberry example DHSEA

Example: cranberry tablets being promoted to increase acidity of the urinary tract and therefore maintaining healthy urinary tract vs. saying it prevents urinary tract infections

administrative law examples

Examples - FDA (administers FD&C Act) - DEA (administers CSA) - State Board of Pharmacy (administers Pharmacy Act) - Department of Health (administers the CSDDCA)

class III devices example

Examples include pacemakers, ***soft or hard contact lenses for extended use***, and replacement heart valves

defeiniitn of bioequivlance

Extent and rate of absorption not significantly different • Extent of absorption is the same and rate is intentionally different as long as: - Not essential to effective drug concentrations - Considered medically insignificant - Reflected in the labeling

who is responsible for making sure supplements are safe?

FDA cannot mandate premarket approval for dietary supplements • Manufacturer is responsible for determining that product is safe and claims are substantiated

class I devices definition

FDA controls over adulteration, misbranding, and manufacturing procedures sufficient to provide reasonable assurance of safety and efficacy

why was the FDMA unconstitutional?

FDAMA also included restrictions on soliciting or advertising the compounding of drugs - Ruled unconstitutional restrictions on free speech - District Court threw out all compounding provisions • Supreme Court upheld the violations of free speech, but did not comment further

OTC drug advertising is regulated by ___

FTC (Federal Trade Commission)

difference between fed register and code

Federal register is ***daily*** publication listing proposed and final regulations and other federal governmental notices • The Code of Federal Regulations (CFR) lists FINAL regulations (updated annually)

natural monopoly

Fixed Costs of providing a good are high relative to the variable costs • Natural Monopolies Example - High cost of initially bringing a drug to market compared to routine costs of production • Intervention = Patent protection

Two Main Laws Governing Pharmacy

Food Drug and Cosmetic Act • Controlled Substance Act (Federal Comprehensive Drug Abuse Prevention and Control Act of 1970

complicance guide regulations

Generally, the FDA will continue to defer to state authorities • Before engaging in any enforcement actions, FDA will consider whether the pharmacy engaged in activities enumerated in the Compliance Policy Guide

what can CNRP not prescribe?

Gold compounds • Heavy metal antagonists • Radioactive agents • Oxytocics

what do OTC drug labels have on them?

Identity of the product & pharmacologic property • Name & address of the mfgr./packer, or distributor • Net contents • Cautions and warnings needed • Adequate directions for use • Drug Facts panel

Is unit-dose packaging considered to be child resistant?

If a child opens or gains access to a bottle/closure package, it is counted as a failure for that package. However, a failure for unit dose packaging is defined as occurring when a child opens or gains access to more than eight individual units or the number of units representing a toxic amount, whichever is less.

What is the responsibility of manufacturers of prescription drugs subject to the PPPA?

If the manufacturer intends that the package of a particular oral prescription drug is to be dispensed directly to the patient by the pharmacist, the CPSC interprets the PPPA to require the manufacturer to market that drug in special packaging pharmacist bears responsibility though ultimately to check

In the case of an antibiotic drug provided by the manufacturer in granular form to be reconstituted by the pharmacist, who is responsible for providing the child-resistant package, the pharmacist or the manufacturer?

If the product is in the same container intended to be given to the purchaser, the manufacturer and the pharmacist are both responsible.

What should I advise a consumer who calls for information when there is a suspected poisoning or childhood ingestion emergency?

If you are unable to provide the necessary emergency information for the caller or advise him or her as to the proper course of action, refer the caller to the Poison Control Center or nearest hospital emergency room. The national Poison Control Center phone number is 1-800-222-1222.

what does the FDA regulate RE: adulteration

Intended to regulate a facility and means of production rather than the product

FDC act prohibitions

Intro into interstate commerce of any "new drug" without an FDA approval Refusal to permit entry or inspection • Manufacture of any ...adulterated or misbranded • Causing a drug to be a counterfeit drug or sale or holding for sale or dispensing of counterfeit drug • Alteration, etc. of label which causes ... to be Adulterated or Misbranded • Intro into Interstate commerce of unsafe Dietary Supplements

When are med guides required?

It could prevent serious adverse effects - Risk information could affect decision to use or continue to use - Patient adherence to directions critical

labeling requirements post D_H

Label must not be false or misleading • Must not be an imitation drug • Must not be sold under the name of another drug • Packaging and labeling must conform to official compendial standards • Must be packaged and labeled appropriately if liable to deterioration • Must be packaged in conformance with the Poison Prevention Packaging Act

differnece between labels and labeling

Label: a display of written, printed or graphic matter upon the immediate container of any article... • Labeling: All labels and other written, printed or graphic matter upon any article or any of its containers or wrappers or accompanying such article (like package inserts)

misbranding definition

Labeling false or misleading in any way • Drug listed in an official compendium and not labeled and packed according to standards • Name and location of manufacturer, packer, or dist. & accurate statement of quantity not listed • Container made, formed, or filled = misleading • Imitation of another drug, or offered for sale under the name of another drug • Drug is subject to deterioration, unless the label bears appropriate cautionary statements • Dangerous to health when used as suggested • Packaged or labeled in violation of the PPPA • Pharmacist sells a drug without a prescription or refills a prescription without authorization

Phase III study

Large-scale randomized controlled trials for effectiveness and relative safety, which are often multi-centered. in persons of interest (disease of interest)

Definition of "narrow therapeutic index"

Less than a two-fold difference b/n median lethal dose and median effective dose, or • Less than a two-fold difference b/n minimum toxic concentrations and minimum effective concentrations

PA rxing blanks

License number of the PA • Printed name of PA • Signature of the PA followed by PA-C • DEA number of PA (if CS) • Supervising physician's name • Signature of physician not required Still need name, not required on CRNP

monograph OTC specs

Monographs not based on single product but rather categories (e.g., antacids) • Monographs specify active ingredients and concentrations, dosage limits, indications • Manufacturer can market product without specific FDA approval as long as complies with monograph

FDA inspections: must be performed how?

Must be conducted - At a reasonable time - In a reasonable manner - And be reasonably limited • Cannot be refused

requiremetns for reg to be valid ****

Must be w/in the scope of the agency's authority - Enabling statute that gives the agency authority - Reasonable relationship to health safety and welfare ***have same legal force as statutes)

rules for tamper evident packaging

Must identify all tamper-evident features • Prominently placed on package • Unaffected if the tamper-evident feature is breached or missing

misbranding and advertising requiremnets

Must include a true statement of: - The established name printed prominently and in type half as large as that used for brand name - Quantitatively formula of each ingredient - Brief summary of side effects, contraindications, and effectiveness

Medroxyprogesterone Acetate Tablets PPPA

N/A

differnece between NME and new indication for W-H amendments

NME: 5 years before generic New indication: 3 years

Prednisone tablets PPPA

NMT 105mg/pkg

RX exceptions to PPPA NAF

NMT 110mg NAF (50mg F)

RX exceptions to PPPA beclamethasone

NMT 12.6 mg drug/pkg

Erythromycin Ethyl Succinate ***Tablets*** Exceptions to PPPA

NMT 16 gm of the drug/pkg

Naproxen PPPA OTC

NMT 250mg/PKG

Conjugated Estrogen Tablets in mnemonic dispenser pkg

NMT 32 mg/drug

Norethindrone Acetate Tablets in mnemonic dispenser pkg PPPA

NMT 50 mg of the drug

RX exceptions to PPPA KCL in dose form

NMT 50meq/dose

RX exceptions to PPPA Mebedazole

NMT 600mg/drug/pkg

RX exceptions to PPPA Erythromycin Ethyl Succinate Granules for oral suspension

NMT 8 gm of the equivalent of erythromycin/pkg

RX exceptions to PPPA methylpred

NMT 84mg/drug/package

who can store samples?

NOT retail hosptial

what is required on bulk RX container labels?

Name & address of the mfgr., packer, or distr. • Established name of the drug product • Quantity and proportion of each active ingredient • Names of inactive ingredients • Qty. in terms of weight or measure (e.g. 100 mg) • Net qty of the container (e.g.,1000 tablets) • Generic and proprietary names • Statement of dosage, or reference to pkg. insert • Legend statement: "Rx only" or "Caution:Federal law..." • Route of administration if not oral • Identifying lot #or control # • Statement specifying container to be used • Expiration date, unless exempted

LABEL requirments post d-H

Name and address of dispenser • Serial # and date of prescription or filling • Name of Prescriber • Name of Patient (if stated) • Directions for use and cautionary statements

how can hospital pharmacies store samples?

Name and address of the requesting practitioner - Name of the hospital - Name, address, title of the one acknowledging receipt - Proprietary/established name of the drug - Quantity, lot number, and delivery date

what is inclsive in transaction info?

Name of the product • Strength and dosage • Specific NDC# • Number of containers • Lot number of the specific product • Date of transaction and shipment • Business name and address of the trading partner sending/receiving the product

when are package inserts required

Oral and Injectable Contraceptives - Ortho Novum - Ortho Tri-Cyclen • Estrogen-Containing Drugs - Conjugated Estrogens (e.g., Premarin) - Diethylstibestrol (DES) • Intrauterine Contraceptive devices

PA label requiremnts

Name, address, telephone number and DEA number of the pharmacy • Name of the patient • Full directions for use • Name of prescriber • Serial number and date originally filled Trade or brand name of the drug, strength, dosage form and quantity dispensed. If generic, mfg name or abbreviated name • On controlled substances, the statement: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"

public goods

Necessary and beneficial commodities that private enterprise will not supply without government intervention • Public Goods Example: - Orphan Drugs • Intervention = Tax Incentives which helps to ensure that drugs will be manufactured

what claims are not allowed under DSHEA?

Never allowed to claim to diagnose, cure, mitigate, treat, or prevent a disease

what is the defnition of new drug? how can it be marketed for interstate commerce?

No new drug may be marketed in interstate commerce unless an NDA has been approved • Drug must be proven to be safe and effective • New Drug is defined as not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drug's labeling

PA rules for BE dispensing

No pharmacist...shall be liable in any way for the dispensing of a generically equivalent drug unless the generically equivalent drug was incorrectly substituted... • Nothing in this Act shall affect hospitals...maintenance of...formulary system

The FDA requires tamper-evident packaging for over-the-counter drugs. Does this replace the requirement for special packaging?

No, , a tamper-evident package is not necessarily child-resistant.

My pharmacy provides drugs to a nursing home. Must these drugs be dispensed in special packaging?

No, as they will not be in possestion of end user before admin

Is it required to get signature for CRC waivers?

No, but highly reccomended

Our local hospital sometimes calls upon my pharmacy to provide drugs for patient use within the hospital. Must these drugs be dispensed in special packaging?

No, provided they are to be used for institutionalized patients. The test is whether the package is likely to enter a home.

Can a State or other political subdivision establish packaging regulations that are more stringent or less stringent than those promulgated by the CPSC?

No. A State or other political subdivision cannot establish packaging regulations that are more stringent than those promulgated by the CPSC. With certain narrow exceptions, they must be identical. However, a State may require child-resistant packaging of a substance not regulated by CPSC

adequete use for directions requirements

Normal dose for each intended use and doses for individuals of different ages • Frequency, duration of admin/application • Administration or application in reference to meals, onset of symptoms, etc • Route of method of admin/application • Any required preparation for use

optometrist CS RXing

Not permitted to prescribe Schedule II • Permitted to prescribe Schedule III-V analgesics if - Therapeutic license - DEA license

what must MFR do with med guides?

Obtain FDA approval for language - Provide sufficient numbers of the guides

What is post marketing surveillance?

Occurs after NDA approval; mfgr must submit reports to FDA • Any serious adverse drug reactions • Any new information relating to drug's safety and efficacy, including info about current clinical studies (Phase IV)

what occurs once a bill passes both bodies

Once a Bill passes the opposite Body, the Bill is referred to a conference committee to work out differences • The committee is made up of ranking members of the Senate and House whose committees were originally involved • Conference committee report is attached, and the Bill must be approved as is

when does a drug get P designation, and what does that mean?

P is a priority drug which appears to represent advance over existing therapy - No other effective drugs are available - More effective or safer than current drugs - Advantages such as greater convenience, reduced side effects, improved tolerance or usefulness

which are more severe penalties, FD and C or PDMA?

PDMA

differnce between PA bulletin and code

Pa Bulletin is ***weekly***publication listing proposed and final regulations and other state governmental notices • The Pennsylvania Code lists FINAL regulations

• Precisely what does the term "special packaging" mean?

Packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance within a reasonable time and not difficult for normal adults to use properly.

w-H amendments brand name changes

Patent term extensions for 2-to 5 years, depending on length of regulatory review - Marketing exclusivity • For any new molecular entity, no application for generic drug may be submitted for five years • 3 years exclusivity for new indications

class II devices def

Performance standards are required to provide reasonable assurances of safety and efficacy

CNM CS rxing

Permitted to prescribe CII through CV • Controlled substances can only be prescribed to treat acute pain • CII limited to 72 hours • CIII-CV limited to 30 days

CS PA Rxing

Permitted to prescribe Schedule II substances - 72 hours supply for initial therapy - 30 days supply for ongoing therapy - Prescription should indicate "initial therapy" or "ongoing therapy" • Permitted to prescribe Schedule III-V substances for up to a 30-day supply and authorize up to 5 refills within a 6-month period also in accordance with collab agreement

definition of pharmaceutical equivalnets

Pharmaceutical equivalents have same - Active ingredients - Strength - Dosage form

Suppose a pharmacist dispenses a prescription drug in a conventional package. What is the Commission's position?

Pharmacists who violate the regulations may be criminally prosecuted. Individuals may be sentenced to 1 year imprisonment and fined up to $250,000. Organizations may be fined up to $500,000.

what does the FDA have to prove to put it on RX vs OTC?

Pharmacologic and toxic effect are such that unless taken per physician's directions, may harm the patient - Patient will suffer harm if he/she relies on a drug that can't cure condition, and postpones visit to the doctor

PA rxing writeen agreement

Physician can delegate prescribing, dispensing and administration of drugs and devices if permitted under the written agreement

RX refill authorization

Physician cannot delegate prescriptive authority to an agent • Agent can transmit refill authorization to the pharmacist

class III devices def

Pre-market approval - Life-supporting or lifesustaining, or - Potential unreasonable risk of illness or injury

Food Drug and Cosmetic Act of 1938 cause

Precipitated by the sulfanilamide disaster • Untested Diethylene Glycol chosen as solvent • 107 Deaths • FDA didn't have authority under to pull the sulfanilamide elixir from the market as unsafe • Relied on the ***misbranding*** provision

principal components of preg and lactation section

Pregnancy and lactation subsections now have three principal components: risk summary, clinical considerations, and a data section

how do refills with different mFR work in pa?

Prescription refills, where permitted by the practitioner, shall be completed using the identical product as dispensed on the original (same manufacturer)

FDAMA 1997

Primarily to streamline the process and to make for expedited availability of safe and effective drugs and devices • ***Fast track approval*** process for drugs treating serious or life-threatening diseases • Expanded FDA authority over OTC drugs and established requirements for ***labeling inactive ingredients***

Rx drug advertising

Product-specific advertising requires true statement regarding side effects, contraindications, and effectiveness • DTC advertising is controversial • All Rx Drug Advertising regulated by FDA

Externalities

Production or consumption of a good affects someone who does not fully consent to the effect, and costs not incorporated into price paid • Externalities Example - Overuse of Antibiotics • Intervention = Rx requirement

Pure Food and Drug Act of 1906

Prohibited adulterated and misbranded foods or drugs from interstate commerce • Identification of ingredients, directions, and warnings not required • False, misleading efficacy claims not misbranding • Misbranding only applied to strength, quality and purity of drug • Manufacturers would purposely leave information off the label

PDMA resales prohibited when

Prohibits the sale, purchase, or trade (or offer to sell...) prescription drugs that have been purchased by hospitals, health care entities, or charitable organizations

function of admin agency law legislation

Promulgate Regulations (interpret and define statutes) • Notice and Comment Procedure (e.g., Fed Register and Pennsylvania Bulletin)

What is the orphan drug act of 1983, adn whom does it apply to?

Provides tax incentives and exclusive licensing incentives to mfgrs. to develop and market drugs for rare diseases • By definition, rare diseases affect less than 200,000 people in the US, or greater than 200, 000 but where there is no reasonable expectation to recoup development costs

Why regulate drugs?

Public Goods - Externalities - Natural Monopolies - Informational Asymmetry health and saftey

what does misbranding require the label to state to avoid being misbranded?

Quantity and/or proportion of any active ingredient of prescription drugs and OTCs (specific mention of alcohol and certain other drugs whether active or not) - Listing of inactive ingredients of prescription drugs and OTCs (alphabetically) - Adequate directions for use (consumer) - Adequate warnings against use by children & others for whom it might be hazardous (consumer) - All conditions, purposes, and uses intended and commonly used (consumer)

which are more detailed, statutes or regulations?

Regulations are more detailed than statutes

Drug Quality and Security Act Title I Compounding Quality Act

Reinstated compounding provisions in § 503A FDAMA--traditional compounding (minus unconstitutional sections) • Created outsourcing facilities in § 503B

is the NDC required on all drugs?

Requested, but not required on all OTC and prescription drug labels and labeling • Presence of an NDC does not indicate that a drug has received an approved NDA

when are supplenmental NDA required?

Required when a manufacturer makes even minor changes in the drug or production

what si required for permanent devices, example pacemakers?

Requires a manufacturer to adopt a method of device tracking to ensure patient notification - Medical Device Amendments of 1992 impose similar tracking requirements on distributors

what does the PPPA apply to?

Requires child-resistant containers (CRC) for oral Rx drugs for human as well as certain OTC drugs

Food, Drug, and Cosmetic Act of 1938

Requires new drugs must be proven safe before marketing requires approval from FDA require adequete directions for use

what drugs were affected by the KH 1962?

Retroactive--drugs marketed b/n '38 & '62

what does the PPPA say for the reuse of containers?

Rx bottles and vials generally cannot be reused • CPSC permits the re-use of ***- Glass container, as long as new CRC cap used*** - Any other package type not prone to wear

when does a drug get S designation from FDA

S is a drug that appears to have therapeutic qualities similar to those of marketed drug

PDMA samples requirements

Sale, purchase, or trade of samples is prohibited (including the offer to sell...) • Sale, purchase, or trade or counterfeiting of drug coupons is also prohibited • Practitioners must request samples in writing each time (no standing orders) • PDMA mandates storage, handling, and record-keeping requirements for samples

when can you import drugs from other counties

Serious condition - No satisfactory treatment available in US - No unreasonable risk - Generally limited to 3 month supply and • Must provide name of US treating doctor or • Evidence of continuation of treatment

PMDA violations individual

Shall be imprisoned for NMT 10 years or fined NMT $250,000 or both

How does a bill become a law?

Signed by President of the Senate and Speaker of the House • Bill then becomes law upon: - Signature of the President - Failure to send Bill back to Congress may veto and send back to congress, need 2/3 of senate AND house to override

differnce between statutes and regulations

Statutes enacted by Legislatures • Regulations enacted by Agencies •

T optomerist Oral agents may RX

Steroids (prednisone and methylprednisolone); antibacterial agents; antivirals; analgesics

concepts of adulteration and misbranding

Strict Liability Offense (i.e., regardless of intent or knowledge) • Good Faith Exceptions (e.g., pharmacist unknowingly receives adulterated drug but gives FDA all details upon request) • Repackaging Concerns (i.e., need identical information that is on the mfgr label)

what did the park doctorine establish?

Strict Liability/Criminal Offense do not need knowledge of issue to be prosecuted for it and convicted

can you sub a B reated drug?

Substituting a B-rated drug for a prescribed drug does not violate the FDCA (i.e. Orange Book is only a guide) • Most state laws allow substitution only if the drug is therapeutically equivalent

consitution componnets

Supreme Law of the United States • Broad Statement of powers of government and its branches • Power rests with the states unless specifically assigned to federal government • States have broad powers to protect health, safety and welfare of public

what drugs do require tamper evident packaging?

Tamper-evident packaging for OTC drugs, cosmetic liquid oral hygiene products; vaginal products, and contact lens solutions and tablets, except two-piece hard gelatin capsules must be sealed using an acceptable tamper-evident technology

Must the customer make the choice for conventional packaging in writing?

The CPSC staff recommends, however, that the pharmacist get a request in writing particularly when a blanket waiver is being requested.

drug approval and off label uses

The drug approval process lags behind the discovery of new uses for drugs • Mfgrs. also recognize that the approval process is faster if fewer indications listed on the NDA • FDA: A prescriber may prescribe an approved drug for an unapproved use, or in a dosage not recommended by the labeling and the pharmacist may dispense such a prescription without violating federal law

when can INV drugs be used to treat patients?

The drug is used to treat a serious or immediately life-threatening disease - No comparable or alternative drug available - Approved IND being used in a controlled drug trial, or all clinical trials have been completed

what must be done if refilling with different MFR?

The person presenting the prescription AND the practitioner authorize in advance a different manufacturer's generically equivalent drug product

responsibility of pharmacist PPPA

The pharmacist must dispense oral prescription drugs in special packaging unless the drug is exempted or the patient or prescribing practitioner requests non-special packaging

How can a pharmacist or pharmacy determine if the prescription packages they use meet the special packaging standards?

The pharmacy should request special packaging test data from the manufacturer or supplier of the prescription packages. When ordering packaging, pharmacists should be aware that vials and closures from different manufacturers may not function properly when used together. Pharmacists are responsible for ensuring that the packages they use comply with the PPPA.

what is inclsive in transaction hx?

The recording of the product's entire transaction history starting with the manufacturer

difference between pharmaceutical equivalance and therapeutic equivalanets

Therapeutic equivalents are pharmaceutical equivalents & same clinical effect and efficacy • Pharmaceutical equivalents that are bioequivalent are presumed to be therapeutically equivalent

May the manufacturer supply to the pharmacist one size of a regulated prescription drug in a conventional package in the same manner as supplying a noncomplying size for other household substances and over-the-counter drugs?

There is no provision for a manufacturer or packager to market a single size of a prescription drug in non-complying packaging as is the case for over-the-counter medications

May a pharmacist dispense a prescription drug in a non-complying package in response to a standing order from a physician that it be so dispensed?

This can be done only when it applies to refills of a prescription where the physician has prescribed non-complying packaging for that prescription new physician - needs to be requesed again for non complying

what must Dietary supplement statements have?

This statement has not been evaluated by the Food and Drug Administration - This product is not intended to diagnose, treat, cure or prevent any disease

Drug Quality and Security Act of 2013 TITTLE I

Title I strengthens oversight of pharmacies engaged in large scale compounding • Can become "outsourcing facility" - Register with the FDA - Comply with GMP's

what is required in track and trace?

Transaction Report - Transaction information - Transaction history - Transaction statement

what did the KH 1962 establish with regards to the FDA?

Transferred jurisdiction of Rx drug advertising from FTC to FDA • Established Good Manufacturing Practices (GMP's)

Kefauver Harris Amendments of 1962 cause and what did it add?

Triggered by the Thalidomide disaster • Strengthened the new drug approval process • ***Added requirement for effectiveness***

tax free OH requirements

Used for scientific, medicinal, and mechanical purposes (e.g., sterilizing solutions, compounding prescriptions, specimen preparation) • May not be sold, but a separate charge may be added for medicines compounded on the premises and dispensed to inpatients • Not to be used as a beverage or food • Medicines compounded using tax free alcohol may not be sold to outpatients or the public

FD and C act violaations

Violations punishable by imprisonment for NMT one year and/or fine of NMT $1,000 • Second offense or violation with intent to defraud or mislead, could be imprisoned for up to 3 years and/or fined up to $10,000

questions to ask when is it a drug?

Was the product intended to diagnose, cure, mitigate, treat or prevent a disease? or - For products (other than food), was it intended to affect body structure/function? • Be sure to make the distinction b/n the supplier's and purchaser's intended use (e.g. DMSO)

informational assymmetry

When the consumer is uneducated about the true value of a good • Informational Asymmetry example - Drugs are hard for consumer to evaluate • Intervention = mandated disclosure of benefits and risks/side effects; etc.

phase I study

a pilot study of a potential drug done with a small number of selected, healthy human volunteers pharmacological activity

Aspirin OTC PPPA

any amount

why is OTC more than?

anything more than that level is regulated

In the case of refills, can prescription ware be reused?

as a general rule no, need a new RX vial, but glass vials with new CRC cap can be used

Right to Try Act

can get drugs for - Terminally Ill - Phase I completed - No FDA oversight - Manufacturer approval still required

What kinds of penaties can FDA do for adulteration and misbranding?

cannot order MFR to remove drug from market, but: Injunctive Relief (seek court action) - Seizure (also called libel action) - Criminal Proceedings (fines and/or prison) - Warning letter (discretionary)

what does the number mean in an NDA application

chemical type

what kinds of penalties can pharmacists face?

civil, criminal, agency- may be all at once

examples of REMS programs

isotretanoin IPLEDGE Thalidomide STEPPS

Dibucaine PPPA OTC

more than 0.5mg/pkg

Midoxinil PPPA OTC

more than 14mg/PKG

Ibuprofen PPPA oTC

more than 1gm/pkg

Tylenol PPPA OTC

more than 1gm/pkg

mouthwashes

more than 3g ethanol/PKG

Flouride PPPA OTC

more than 50mg/pkg

Ketoprofen PPPA OTC

more than 50mg/pkg

diphenhydramine PPPA OTC

more than 66gm/PKG

Sacrosidase (sucrase) in glycerol and water PPPA

n/A

oral contraceptives PPPA

n/A

Aerosol Preparations intended for inhalation exceptions to PPPA

n/a

OTC drugs that were available by rx PPPA

n/a

Pancrelipase preparations PPPA

n/a

RX exceptions to PPPA Anhydrous cholystyramine

n/a

RX exceptions to PPPA- NG

n/a

Hormone replacement therapy products that rely solely upon activity of one or more progestogen or estrogen substances

n?A

class I devices example

needles, stethoscopes, scissors, toothbrushes, tongue depressors

can use good faith defense on recalled products?

no, Dispensing recalled products might be a violation of the FDCA • Good faith defense hard to assert for dispensing recalled product • Civil liability also possible if patient injury • Administrative penalties possible also all 3 penalties possible

Does the regulatory reference to "dosage forms intended for oral administration" include drugs intended for topical application to the teeth or mouth, or a dosage form intended for inhalation?

no, if not systemic, not applicable

Whom cana get EC?

one time pill- any age

which drugs were exempt from FDCA of 1938?

pre 1938 meds, providing that: No subsequent labeling changes - No subsequent changes in indications

when are elements to assure safe use implemented

reserved for drugs associated with a serious risk of adverse drug experiences that would otherwise be denied approval or withdrawn

which items of regulation can be commented on?

the bulletin in PA and the register in federal codes are FINAL

Who is responsible for determining at the retail level whether or not a prescription drug must be packaged in accordance with PPPA standards?

the pharmacist

class II devices example

thermometers, syringes, daily use contacts, electric heating pads, diagnostic reagents

Can a physician simply check a box on a prescription blank to indicate to the pharmacist that a drug be dispensed in noncomplying packaging?

this is not reccomended

Drug Quality and Security Act of 2013 TITTLE II

track and trace requirements for all entities in chain of distribution and replaces pedigree requirement of PDMA

RX exceptions to PPPA Colispitol powder

up to 5gm in packet

medicaiton guides REMS

used to inform patients about the safe and effective use of a drug

Can a supplier of special packaging include an equal number of non-complying closures with each carton of complying packaging shipped to pharmacies

yes!

I know of several physicians who dispense prescription drugs for a fee. Are they subject to the provisions of the PPPA?

yes, Section 4(b) of the PPPA gives medical practitioners the authority to specify conventional packaging for drugs they prescribe

Are Investigational New Drugs (IND's) subject to the PPPA standards?

yes, Such drugs must be packaged in a special package.

May an individual request that all of his/her prescriptions be filled in conventional (nonspecial) packaging?

yes, but A single request is not a blanket waiver

May I, as a hospital pharmacist, dispense a regulated drug in a conventional package for use by a patient in the hospital?

yes, not if going outpatient Yes, provided that the patient is confined in the hospital. Drugs dispensed for outpatient use must be packaged in accordance with the applicable regulations for special packaging.

examples of NTW (narrow thera window) Drugs

• Carbamazepine, clonidine, levothyroxine, lithium, phenytoin, warfarin

BUD example unit dose

• Example: In order to repack on 9/1/18 with a 6 month beyond use date, the manufacturer's container must have an expiration date of 9/1/20 or later

when can FDA pull a supplement?

• FDA has to prove that a DS is unsafe before removing it from the market

how many days should MFR notify FDA with permitted sstatements

• Manufacturer must notify the FDA within 30 days if it makes one of the permitted nutritional support statements

what is defined as CRC container

• Requires 80% of those under 5 cannot open • Requires 90% of adults can open

unit dose test failure PPPA

• Unit-dose test failure if child can open more than eight doses or toxic amount, whichever is less