Federal Pharmacy Law

reasons to regulate drugs
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Terms in this set (76)
reasons to regulate drugs
market failures

public goods

externalities
- could be + or -
- +: When consuming a good gives a benefit to other
- -: Consuming a good causes a harmful effect on third parties.

natural monopolies

information asymmetry
de minimis violations
A De Minimis violation is a technical violation of OSHA rules that have no direct impact on health or safety. It is the least serious class of violation, and OSHA inspectors typically do not levy fines or issue citations for these types of violations.
administrative agencies such as the FDA and DEA fall under the blank branch but also have blank functions
executive branch

legislative functions
- promulgate regulations

judicial functions
- hearings
stare decisi
Stare decisis is a legal doctrine that obligates courts to follow historical cases when making a ruling on a similar case. Stare decisis ensures that cases with similar scenarios and facts are approached in the same way. Simply put, it binds courts to follow legal precedents set by previous decisions.
criminal, civil, and administration actions
•Criminal: Government v. private party

•Civil: Private party v. private party

•Administrative: Agency v. private party
pre-emption doctrine
The preemption doctrine refers to the idea that a higher authority of law will displace the law of a lower authority of law when the two authorities come into conflict.
Food, Drug, and Cosmetic Act (FDCA)
1938 FDCA: said that a manufacturer could not release a product without it being safe when used according to the label. So, the FDCA (which is the backbone statute that will later grow into the FDA as we know it today), required safety, but not efficacy
1962 Kefauver-Harris Amendment
1962 amendment to the FDCA

All drugs made from 1938 forward must be proven save and effective. Also the FTC now handles drug advertisement. Stricter requirements for drug approval. Manufacturers must now register annually, be inspected ever 2 years, and report adverse effects of drugs.
Also established the IND and GMPs

Drugs that were on the market before the 1962 K-H were grandfathered in IF the labeled indication stayed the same from before to after the 1962 law
1951 Durham-Humphrey Amendment
1951 amendment to the FDCA

Before it was enacted, each manufacturer was tasked with the burden of determining whether or not their drug should be prescription only or OTC, which lead to drugs that have the same active ingredient having different Rx/OTC statuses, which is stupid. The Durham-Humphrey act instead shifted this responsibility from the individual manufacturers to the FDA. Some other things the Durham-Humphrey act did was establish the legality of verbal prescriptions and refills (makes things easier; before you needed to get a new script for each refill which is inconvenient), establish expiration dating/BUDs, and allow for state governments to decide what goes on a dispensed prescription medication label (so they don't have to infodump everything about the drug that the manufacturer tells the pharmacy)
21st Century Cures Act of 2016
FDCA amendment

-Meant to streamline the approval process of drugs using data that manufacturers have gathered that don't meet the standards of double blind placebo RCTs

-Born out of the idea that the process of drug approval is a little archaic

-Also meant to incentive manufacturers to pursue the development of novel agents that will affect smaller populations of patients
FDA Reauthorization Actrequires drug manufacturers to pay fees to the FDA- trying to be fair to smaller companies. Fees are based on the number of approved drugs or devices that they produceDESI ReviewDrug Efficacy Study Implementation Program and the Prescription Drug Wrap-Up •Evaluate the effectiveness of drugs approved between 1938 and 1962 •For drugs not approved between 1938 and 1962, but were commercially available, as stated in Section 107, are generally known as "Prescription Drug Wrap-Up" -Not Subject to DESI Review -"GRASE"so, what is a grandfathered drug•Not approved, but legal and permitted to Market •Pre-1962 (before the 1962 Kefauver-Harris Amendment) •Labeling and intended use has and cannot change after the 1962 Kefauver-Harris AmendmentFood and Drug Administration Modernization Act (FDAMA) 1997•First major overhaul of FDC Act in over 30 years •Created a "Fast track" process to facilitate the development and approval of drugs to treat serious and life- threatening conditions. •Clarified FDA's position on compounding by pharmacies: -Should appropriately regulated by states -Exempts pharmacies from NDA and CGMP requirements when compounding drugs for an individual patient •Replaced the full statement with "Rx only" designation for legend drugs •Encouraged pediatric studies from manufacturer -Gain 6 additional months of exclusivity •Encouraged research for new uses of drugs through SNDA (supplemental new drug application) - SNDA = application for getting a new indication for an already existing drug approved3 functions of the FDA1. rulemaking 2. issue guidance documents 3. incorporate advice from standing advisory committees of outside expertsdrug definition•Food, Drug, and Cosmetic Act defines "drug" as any article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or function of the body."Dietary Supplement Health and Education Act (DSHEA) of 1994- definition of a supplement•"[P]roduct (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: -Vitamin; -Mineral; -Herb or other botanical; -Amino acid; -Dietary substance for use by man to supplement the diet by increasing the total dietary intake; or -A concentrate, metabolite, constituent, extract, or combination of [the above]. •If a supplement meets the statutory definition, then: -No premarket approval requirement or submission of safety information -FDA must prove substance unsafe for removal from market -No strict labeling requirementsDSHEA allows 4 types of "nutritional support" statements (and other labeling requirements)1. Claim a benefit related to classical nutrient deficiency disease 2. Describe how ingredients affect the structure or function of the human body 3. Characterize the documented mechanism by which ingredients act to maintain structure o4 function 4. Describe general well-being from consumption of ingredients CANNOT be a "drug claim" must be truthful and not misleading •Must state, "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."2007 final rule regarding dietary supplementscGMP compliance must be met when manufacturing dietary supplementswho regulates advertising issues related to dietary supplements?FTCINDAInvestigational New Drug Application filed before you starting doing human clinical trials - contains "pre-clinical" (animal) data to prove that this drug would be safe to test in humansPhase I-IV clinical trials-Phase 1- detect adverse affects -Phase 2- limited safety and efficacy -Phase 3- full safety and efficacy -Phase 4- post marketing dataANDAabbreviated NDA - used when getting a new generic approvedWaxman-Hatch Amendment of 1984 (AKA Drug Price Competition and Patent-Term Restoration Act)created the ANDA so generics could get to market easier also guaranteed the manufacturer's of the branded product a period of exclusivityBiologics Price Competition and Innovation Actcreated a regulatory framework in 2010 for biosimilars or "follow on" biologics. (how we're going to make "generic" versions of biologics)Good Manufacturing Practices (GMP)must be registered with the FDA regularly inspected generally every 2 yearsadulterationThere's something in the drug that shouldn't be, the strength/purity of the drug is different/less than what it should bemisbanrdinghas to do with LABELING! PPA = Poison Prevention ActBUD following bubble packingBUD = 60 daysexpiration following unit-dose packagingthe expiration date changes to 1 year after it was repackaged or sooner if the expiration on the stock bottle is soonerpackage insertsmust be approved by the FDA must be informational, not promotionalclasses of product recalls•Class I- harm is likely (stocks in pharmacy + patient notification) •Class II- temporary or reversible effects (stocks in pharmacies) •Class III- technical, no adverse health consequences •"Voluntary recall"- potentially dangerous product, e.g., PPAFDA Administration Amendments Act of 2007created REMS programs Incentivized manufacturers to do pediatric studies with their drugsall drug promotion must beon-labelwho regulates drug promotionFDA Office of Prescription Drug Promotion (OPDP)Physician Sunshine Actrequires medical product manufacturers to disclose to the Centers for Medicare and Medicaid Services (CMS) any payments or other transfers of value made to physicians or teaching hospitalsrequirements for direct to consumer adveritisngsubject to FDA scrutiny must be accurate and include a "fair balance": explanation of the risk vs benefit of the drug comply with approved labeling one thing you CANT do in DTCA: compare 2 drugs. the layperson isnt equipped to adequately understand/analyze a scientific comparison of 2 drugs information provided must be "true statements"Reminder Advertisingex: "Ask your doctor ads" can include the name of the product, but NOT the indication (must be careful with suggesting the indication through visual clues) or dosagedirect to consumer advertising of OTCs is regulated by theFTC NOT the FDA!Dingle BillPrescription Drug Marketing Act of 1987 •Proper storage of drugs and appropriate distribution records •Prohibit shipping between states w/out being reg in state shipped •Prohibits re- importation •State lic of wholesalers •Restrict sale, purchase, or trade of Rx samples •Allows use of starter packsFederal Anti-Tampering Act of 1982required tamper-resistant packaging on select OTC products and cosmetics provides barrier-to-entry and protects against intentional contamination of OTCs package must indicate it is tamper-evident and how to determine if it has been tampered withPatient Package InsertsGiven with each rx in outpt setting - FDA approved - the FDA wanted it to be required for all drugs, but instead it is Required for all estrogen containing drugs Given before first dose and every 30 days thereafter in inpt setting - If not provided, then considered misbranding applies to institutional pharmacy as well as communityMedication Guides (MedGuides)required for drugs that the FDA has determined as posing "serious and significant concerns" required for new and refill prescriptions content of MedGUide must be approved by FDA every new MedGuide approved since 2007 has been in conjunction with a REMSwhat is compounding?defined by state law •A process by which a pharmacist combines, mixes or alters ingredients to create a medication tailored to the needs of the individual patient based on the receipt of a valid prescription from an authorized prescriber.Drug Quality and Security Act (DQSA)2013 consists of 2 Titles: 1) Compounding Quality Act 2) Drug Supply Chain SecurityCompounding Quality Acttwo basic regulatory schemes: 1) traditional state licensed pharmacies 2) outsourcing facilities traditional state licensed pharmacies are not subject to 503a (cGMP, etc.) and continue to be regulated by state pharmacy boards outsourcing facilities - sterile compounding - facilities register with FDA (registration is voluntary) - allows for "office use" compounding, which is not allowed otherwiseDrug Supply Chain Security Act3 components: 1. Traceability: establishes a 2-phased national system for tracing pharmaceutical products through the supply chain - Phase 1: Product tracing- supply chain partners pass transactional data to subsequent purchasers (data exchange occurs with change of ownership only) - Phase 2: Product identifier- supply chain partners trace product identifiers through the supply chain 2. Licensing: establish uniform national licensing standards for wholesale distributors and 3rd party logistics providers 3. Pre-emption: immediately pre-empts all state laws and regulations for tracing products through the supply chain AND state laws regarding wholesalersExemptions from the Drug Supply Chain Security ActOTCs compounds IV products imaging and radiological products transfer between pharmacies for an identified patient, limited quantities for pharmacy to licensed practitioner for office use, distribution for emergency reasonsDrug product selection: Pharmaceutical equivalents definitiondrugs for which the API, dosage form, strength, route of admin, etc are the sameDrug product selection: Bioequivalencedrugs for which the pharmacokinetic properties are the same (ADME, time to peak, peak concentration, AUC, etc)Drug product selection: Therapeutic equivalentsTherapeutic equivalents are basically drugs for which the API, dosage form, strength, etc are the same (pharmaceutical equivalents), AND the pharmacokinetic properties are the same (bioequivalence)Drug product selection: Pharmaceutical alternativePharmaceutical alternatives are when you have two drugs, but something like the salt or dosage form might differ (like hydroxyzine HCl vs hydroxyzine pamoate). As such, pharmaceutical alternatives cannot be pharmaceutical equivalents (and therefore therapeutic equivalents) simultaneouslyOrange Bookthe common name for the FDA's Approved Drug Products with Therapeutic Equivalenceequivalence ratings (A, B, AB, etc)A-rated = bioequivalent and thus therapeutically equivalent B-rated = not bioequivalent AB-rated = meets "necessary bioequivalene requirements" - further expanded into AB1, AB2, AB3, etc.HIPAA does or does not preempt state laws?HIPAA DOES NOT preempt state laws, so it MUST be read in conjunction with SC privacy requirementsOBRA-90Omnibus Budget Reconciliation Act of 1990 - established conditions for federal govt to reimburse states for outpatient Medicaid services - established DUR (Drug Utilization Review) - established rebates from manufacturers to Medicaid programs - established patient counseling standards applicable to Medicaid patientsRetrospective drug review (established by OBRA-90)committee of healthcare professionals reviews use of certain drugs over time to make sure appropriate therapy is being used may recommend that some prescribing habits of physicians be changed may initiate educational programs for bother physicians and pharmacistsOBRA-90 Patient CounselingOBRA-90 established patient counseling standards applicable to Medicaid patients because the fed govt cannot directly regulate pharmacy practice act of each state, individual states had to determine how to impose this added responsibility on pharmacists according to SC, the pharmacist (not a tech, intern, clerk, etc) must PERSONALLY offer counseling to the patient although the statute was specifically directed toward Medicaid patients, must states have expanded patient counseling requirements to apply to ALL patients signing a counseling form constitutes an offer written information (ex: print-out that goes along with the med) DOES NOT meet your statutory duty to offer counseling not required for inpatients or emergency departments where other healthcare professionals are authorized to administer the drug not required to counsel the patient/caregiver when the patient refuses the consultation (must document the refusal)federal regulations of LTCFsa. Each resident's drug therapy must be free from unnecessary drugs b. Medication error rates cannot exceed 5% c. Each resident must have a drug regimen review at least once per month done by a consultant pharmacistSherman Antitrust ActFirst federal action against monopolies "Per se" means "in itself or "by itself". Thus, if an act is categorized as illegal per se, it means that it does not require any additional proof or surrounding circumstances, such as intent or a criminal mindset. Merely committing the act would make a person liable for the violation. Types of per se violations under the Sherman Antitrust Act: - Price fixing - Boycotting - Tying arrangements examples of violations: a. Price fixing: Two pharmacies agreeing to set costs for consultation activities at a certain threshold so as to not underprice each other b. Boycotting: Two pharmacies agreeing to not accept a certain type of third party plan unless reimbursement level rises c. Tying arrangements: A manufacturer requiring that a special blood monitoring service be purchased upon dispensing a medication for which the manufacturer currently exclusivityProduct liability and the PharmacistPharmacists aren't generally held accountable for product liability because we usually don't choose to give the product to patients; according to the learned intermediary doctrine, manufacturer is supposed to inform the prescriber/doctor (or "learned intermediary") of product liability issues, not the pharmacist So, who is liable? Sellers and manufacturers of goodsRyan Haight Online Pharmacy Consumer Protection Act of 2008amends the Controlled Substances Act to prohibit the delivery, distribution, or dispensing of controlled substances over the internet without a valid prescription (exempts telemedicine practitioners)DEA Form 224New application for Retail pharmacy, hospital, practitioner, teaching institution, mid level practioner in order to handle controlled substances after initial registration period, if expires in 36 months renewal forms should be sent 60 days prior to expirationDEA Form 225New Registration for Manufacturer, Distributor, Lab, Importer, Exporter in order to handle controlled substancesDEA Form 363New Application Registration - Narcotic Treatment ProgramDEA Form 222Anytime there is the transfer of schedule II between registrants (AKA pharmacy, wholesalers, prescribers, etc.- anyone with a DEA number), a form 222 form MUST BE INVOLVED!!! Schedules 3-5 do not require a 222 form If a person who is not the registrant wants to order C-II's, they have to have Power of Authority given to them by the registrant (ex: This is how Theresa can order C-IIs). Make sure you can produce this power of attorney document when promptedWhat happens with the 3 copies of a 222 formPharmacy submits Copy 1 & 2 to supplier; pharmacy retains 3rd Copy •Supplier records number of containers on Copies 1 & 2 (can partially fill but must supply balance in 60 days) •Shipped to purchaser at location on form •Supplier retains Copy 1, send Copy 2 to DEA at end of month (partial fill complete) •Purchaser record son Copy 3 qty received and date must retain order forms and related documents for 2 years must return unused order forms in the pharmacy goes out of business, changes its name or addressoral prescribing of C-II'sonly allowed in case of an emergency - quantity prescribed and dispense must match the parameters of the emergency - immediately reduce to writing - SC law: Must receive original script (written/electronic) in 72 hours (federal law says 7 days). Pharmacy must notify the DEA if Rx not received - document on Rx: "Emergency Dispensing"3 exceptions to not faxing C-IIsYou cannot fax C-II prescriptions, except in these 3 cases: - the C-II is part of a compound - patient is a resident of a LTCF - patient is a hospice patient document on the prescription which exception applies to the situationpartial filling of C-II's is not allowed except....if the patient requests for the prescription to be partial filled if the pharmacy doesnt have enough on hand to fill the whole quantity if the patient is in a LTCF or hospicedispensing C-V without a prescriptioncan only be done by a pharmacist purchaser must be at least 18 y/o NMT 240mL or 48 dosage units of a CS containing opium NMT 120mL or 24 dosage units of any other CSDEA Form 41form used by pharmacies to destroy controlled substancesDEA numberssecond letter is 1st letter of last name Mid-level practitioners (ex: NP, PA) begin with the letter 'M' Dr Robert Jones DEA Number BJ3614511 Add numbers #1, #3, #5 (3+1+5=9) Add 2nd, 4th, & 6th numbers and multiply by 2 (6+4+1=11X2=22) Add odd number total + even number total multiplied by 2 (9+22=31) Last number equals last number of DEA #DEA Form 106Theft of controlled substancesMethamphetamine Anti-Proliferation Act of 2000 (MAPA)addresses diversion of pseudoephedrine and PPA from retail pharmacies to illicit production of meth limits: NMT 9 grams within 30 days; NMT 3.6 grams in a single transactionCorresponding Liability DoctrineSays that the doctor AND the pharmacist have a responsibility to make sure a prescription is safe for a patient and have a legitimate medical purpose