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Chapter A Federal Food, Drug and Cosmetic Act (FDCA) and Other Federal Laws and Regulations Copyright © 2024 Gary Cacciatore FDCA – Major Amendments A.1-2 2 ◈ Federal Food, Drug, and Cosmetic Act (FDCA) – 1938 ◈ Durham-Humphrey Amendments – 1951 ⬩ Established two classes of drugs (know which drugs a...

Chapter A Federal Food, Drug and Cosmetic Act (FDCA) and Other Federal Laws and Regulations Copyright © 2024 Gary Cacciatore FDCA – Major Amendments A.1-2 2 ◈ Federal Food, Drug, and Cosmetic Act (FDCA) – 1938 ◈ Durham-Humphrey Amendments – 1951 ⬩ Established two classes of drugs (know which drugs are Rx and OTC) ◈ Kefauver-Harris Amendments – 1962 ⬩ Established efficacy requirement Copyright © 2024 Gary Cacciatore FDCA – Major Amendments A.2 3 ◈ Drug Abuse Control Amendments – 1965 ⬩ Controlled use of depressants, stimulants, hallucinogens – precursor to the Federal Controlled Substances Act (FCSA) of 1970 ◈ Orphan Drug Act –1983 ⬩ Incentives to develop drugs to treat rare diseases ◈ Drug Price Competition and Patent Term Restoration Act – 1984 (Hatch-Waxman) ⬩ ANDA process for generic drug approval Copyright © 2024 Gary Cacciatore FDCA – Major Amendments A.2-3 4 ◈ Prescription Drug Marketing Act (PDMA) – 1987 ⬩ Bans reimportation of drugs ⬩ Bans sale, trade, or purchase of Rx samples ⬩ Bans resale of Rx drugs purchased by hospitals ◈ FDA Modernization Act (FDAMA) – 1997 ⬩ Legend “Rx only” ⬩ Attempted to clarify compounding vs. manufacturing Copyright © 2024 Gary Cacciatore FDCA – Major Amendments A.4 5 ◈ Food and Drug Administration Amendments Act (FDAAA ) – 2007 ⬩ Established REMS ⬩ Enhanced FDA’s authority for post-marketing safety of drugs ⬩ Requires side effects toll free number statement Copyright © 2024 Gary Cacciatore FDCA – Major Amendments A.4 6 ◈ Biologics Price Competition and Innovation Act – 2009 ⬩ Created an abbreviated approval pathway for biological drugs that are “biosimilar” and may be “interchangeable” to FDA licensed biological product (similar to ANDA process for generic drugs) ⬩ “Purple Book” ◈ FDA Safety and Innovation Act – 2012 ⬩ Improved authority and funds for foreign facility inspections Copyright © 2024 Gary Cacciatore FDCA – Major Amendments A.5-6 7 ◈ The Drug Quality and Security Act (DQSA) – 2013 ⬩ Compounding Quality Act (CQA) – Addresses large scale compounding by pharmacies ⬩ 503A compounding – patient specific, regulated by states ⬩ 503B compounding – non-patient specific; Outsourcing Facilities, regulated by FDA and states ⬩ FDA Memorandum of Understanding (MOU) with states to address large scale interstate distribution of compounded products is now on hold. Copyright © 2024 Gary Cacciatore FDCA – Major Amendments A.6-8 8 ◈ The Drug Quality and Security Act (DQSA) – 2013 ⬩ Implements uniform “track and trace” system for drug supply ⬩ ⬩ ⬩ ⬩ ⬩ ⬩ chain Final implementation was in November 2023, but FDA is not enforcing some provisions until 2024. Some products are exempt Tracks and traces drug ownership using product identifier and providing of Transaction Data Pharmacies must investigate and properly handle suspect products and illegitimate products. FDA Form 3911 used to notify FDA of illegitimate products FDA has proposed rule for wholesale licensing. Copyright © 2024 Gary Cacciatore FDCA – Definitions A.8-9 9 ◈ Key to understanding the law ◈ Always read the definition section of any law or rule. ◈ Applicable to all subject matter Copyright © 2024 Gary Cacciatore Prohibited Acts A.9-10 10 ◈ Adulterated drugs (adulteration) ⬩ Primarily deals with purity, cleanliness, and strength ⬩ Quality problems at manufacturing facility Copyright © 2024 Gary Cacciatore Prohibited Acts A.10 11 ◈ Misbranded drugs (misbranding) ⬩ False or misleading labeling (broad definition of labeling) ⬩ Label does not contain required elements ⬩ When Rx dispensed, it is exempt from FDA labeling requirements. ⬩ Failure to include adequate information for use with a prescription drug product such as medication guide or patient package insert Copyright © 2024 Gary Cacciatore OTC Drug Regulation A.10-12 12 ◈ FDA OTC Review ⬩ Evaluates safety and effectiveness of OTC drug products ⬩ 3 phases and 3 categories ◈ OTC Drug Approval ⬩ OTC Monographs ◈ OTC Labeling – Required elements Copyright © 2024 Gary Cacciatore Special Warnings A.12-13 13 ◈ Mineral oil ◈ Wintergreen oil (>5% methyl salicylate) ◈ Ipecac syrup ⬩ Only sold in 30ml containers ◈ Salicylates ⬩ Warning regarding Reye’s syndrome ⬩ Pediatric ASA – Not more than 36 tablets ◈ OTC Pain Relievers ◈ OTC Products containing iron Copyright © 2024 Gary Cacciatore Packaging & Repackaging of OTC Drugs and OTC Drugs Filled as Prescription A.13-14 14 ◈ Tamper Evident Packaging ◈ Repackaging of OTC drugs ◈ OTC Drugs filled as Rx not subject to OTC labeling ⬩ If an OTC dose is different than indicated on labeling, a prescription would be required. Copyright © 2024 Gary Cacciatore Drug and Device Recall A.14 15 ◈ Class I ⬩ Serious adverse effects on health or death ◈ Class II ⬩ Temporary or medically reversible adverse effects on health ◈ Class III ⬩ Not likely to cause adverse health consequences Copyright © 2024 Gary Cacciatore Advertising A.14-15 16 ◈ Prescription Drugs – FDA ◈ Over-the-Counter (OTC) Drugs – FTC ◈ Advertising of drug prices (including by pharmacists) is considered “reminder advertising” by FDA but is exempt from FDA advertising regulations if certain conditions are met. Copyright © 2024 Gary Cacciatore Patient Package Inserts A.15 17 ◈ Required for ⬩ Oral contraceptives (Rx version) ⬩ Estrogen products ◈ Special rules for hospital patients ⬩ Prior to first administration ⬩ Every 30 days thereafter Copyright © 2024 Gary Cacciatore Medication Guides A.15-16 18 ◈ Similar to PPI but for generally required for outpatient only ◈ Required when: ⬩ Serious adverse effects could be prevented ⬩ Serious risks relevant to benefits ⬩ Adherence to directions is crucial ◈ List of drugs and drug classes ⬩ Includes Accutane, Lotronex, Lindane, NSAIDS, Opioid analgesics and cough products Copyright © 2024 Gary Cacciatore Risk Evaluation and Mitigation Strategies (REMS) A.16-18 19 ◈ Strategy to manage serious risks with certain drugs ◈ May include restricted distribution; special training; certification for prescribers, pharmacists, or patients; monitoring; medication guides; etc. Copyright © 2024 Gary Cacciatore Risk Evaluation and Mitigation Strategies (REMS) (cont.) A.17 20 ◈ Example ⬩ Accutane (isotretinoin) iPledge program ⬩ Pharmacy must register “responsible pharmacist”. ⬩ Authorization to dispense via Internet or phone ⬩ Rx must be picked up within 7 days of negative pregnancy test. ⬩ 30-day supply only, no refills ◈ Often a component of specialty pharmacy practices Copyright © 2024 Gary Cacciatore New Drugs and Approved Drugs for Unapproved Uses A.18-19 21 ◈ Physicians may legally prescribe (and pharmacists may dispense) drugs for unapproved (off-label) uses. ◈ Pharmacists should use professional judgment to minimize liability. ◈ FDA generally prohibits manufacturers from promoting offlabel uses except under certain conditions. ⬩ Commercial free speech implications Copyright © 2024 Gary Cacciatore National Drug Code (NDC) A.19-20 22 ◈ The NDC code is not technically legally required to be on the manufacturer’s label. ◈ However, nearly all manufacturers include it on the label. ◈ Because it is technically not required by FDA, having an NDC number does not indicate that a drug has been approved by FDA. ◈ There are unapproved drugs on the market with NDC numbers. ◈ FDA has proposed a new 12-digit NDC code. Copyright © 2024 Gary Cacciatore Current Good Manufacturing Practices (CGMP) 23 A.20 ◈ When do CGMPs apply to pharmacies? ◈ CGMPs apply to repackaging drugs for sale or distribution to other pharmacies. ◈ Texas law allows one hospital to repackage for another hospital under common ownership or control without being a manufacturer or wholesaler. Copyright © 2024 Gary Cacciatore FDA Orange Book A.20-21 24 ◈ Orange Book ⬩ Primary source for determining generic equivalency for drugs ⬩ A = equivalent; B = not equivalent ⬩ Second letter relates to dosage form ⬩ Products must be AA or AB rated to be generic equivalent. Copyright © 2024 Gary Cacciatore FDA Purple Book A.21 25 ◈ Purple Book ⬩ Primary source for determining biosimilarity and interchangeability of biological products ⬩ FDA approved the first interchangeable biosimilar in 2021. Copyright © 2024 Gary Cacciatore Dietary Supplements and Medical Foods A.21 26 ◈ Dietary Supplement definition ⬩ A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, herb or botanical, amino acid, and/or dietary substance used to supplement the diet of any ingredient above Copyright © 2024 Gary Cacciatore Dietary Supplement &Health Education Act A.21-22 27 ◈ Places burden on FDA to prove that a dietary supplement is unsafe before removing from market ◈ Dietary supplements can’t make claims they treat, prevent, or cure a specific disease, but can make certain health claims, structure/function claims, and nutrient content claims with a disclaimer. ⬩ Often difficult to distinguish dietary supplement claims form drug claims Copyright © 2024 Gary Cacciatore Dietary Supplement Regulation (cont.) A.22-23 28 ◈ CGMPs for Dietary Supplements ◈ The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 ⬩ Requires dietary supplement manufacturers, packers, or distributors to report serious adverse effects to the FDA ◈ Medical Foods ⬩ Intended to be consumed under supervision of a physician, but are not drugs and are not prescription products ⬩ Should not contain “Rx only” on label Copyright © 2024 Gary Cacciatore Medical Devices A.23-26 29 ◈ Medical Device definition – main difference from drug “does not achieve its desired action by chemical action or being metabolized" ◈ Classification of devices ⬩ Class I ⬩ Class II ⬩ Class III ◈ Prescription Devices ◈ Unique Device Identifier (UDI) Copyright © 2024 Gary Cacciatore Animal Drugs A.26 30 ◈ FDA determines if Rx or OTC ◈ Veterinary Legend: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” ◈ FDA has guidelines for compounding animal drugs. Copyright © 2024 Gary Cacciatore Provisions of Other Federal Laws A.26-27 31 ◈ Federal Hazardous Substances Act of 1996 ⬩ Administered and enforced by CPSC ⬩ Does not apply to drugs ⬩ Primarily applies to household products ◈ Federal Hazardous Communication Standard ⬩ Administered and enforced by OSHA ⬩ Drugs in solid dosage form (tablets, capsules) are exempt but may apply to drugs that are hazardous Copyright © 2024 Gary Cacciatore Poison Prevention Packaging Act of 1970 (PPPA) A.27-28 32 ◈ Administered by the Consumer Product Safety Commission (CPSC) ◈ Primary requirement applicable to pharmacies ⬩ Requires child resistant container for Rx drugs and certain OTC drugs Copyright © 2024 Gary Cacciatore Poison Prevention Packaging Act of 1970 (PPPA) (cont.) A.28-30 33 ◈ Exemptions ⬩ Patient or physician request ⬩ Not required to be in writing but best practice to do so ⬩ Physician can’t give blanket request ⬩ Bulk containers ⬩ Drugs to institutionalized patients ⬩ One OTC package size for elderly ⬩ Specific drugs exempted ⬩ Some for therapeutic reasons (NTG) ⬩ Some due to packaging of product (oral contraceptives) Copyright © 2024 Gary Cacciatore Omnibus Budget Reconciliation Act of 1990 (OBRA-90) A.30 34 ◈ Expansion of Medicare and Medicaid programs ◈ Federally applied to Medicaid patients ⬩ Texas rules apply to all patients receiving pharmaceutical services (discussed under Class A rules). ◈ Pharmacy relevant components ⬩ Patient profiles ⬩ Mandatory drug use review ⬩ Patient counseling Copyright © 2024 Gary Cacciatore CMS Requirements for Pharmacy Services at Long-term Care Facilities (LTCFs) A.30 35 ◈ ◈ ◈ ◈ Medication regimen review every 30-days. Special rules for psychotropic drugs Most drugs cannot be dispensed in more than a 14-day cycle Emergency drug kit required Copyright © 2024 Gary Cacciatore U.S. Postal Regulations A.30-31 36 Noncontrolled substances ⬩ No alcoholic beverages, poisons, or flammable substances ◈ Controlled substances ⬩ Packaging can’t identify contents and any other markings (including name of pharmacy on return address) that would indicate nature of contents ◈ Copyright © 2024 Gary Cacciatore Additional Regulations A.31-32 37 ◈ Tamper-Resistant Rx Requirements (CMS) ⬩ Written prescriptions ⬩ Exemptions ◈ Federal Alcohol Regulations ⬩ Administered by Alcohol and Tobacco Tax and Trade Bureau (TTB) ⬩ “Tax free” ethyl alcohol ⬩ Research labs, hospitals or other locations using it may need permit and must follow recordkeeping requirements Copyright © 2024 Gary Cacciatore COVID-19 Laws and Policies A.3 38 ◈ Public Health Readiness and Emergency Preparedness (PREP) Act ⬩ Prep Act declarations expanded authority of pharmacists, interns and pha2rmacy technicians to provide COVID-19 vaccines, flu vaccines, and COVID-19 tests and therapeutics. ⬩ Authorities under the PREP Act will expire December 31, 2024 and then state law will apply. ⬩ Texas has not made the authorities under the PREP Act permanent under state law. See Charts in Chapter D. Copyright © 2024 Gary Cacciatore Health Insurance Portability and Accountability Act of 1996 (HIPAA) A.32-33 39 ◈ Portability ⬩ Refers to making health insurance “portable” by making it easier for people to continue their health insurance after leaving a job ◈ Major provisions – 3 sets of regulations ⬩ HIPAA Transactions and Code Set Regulations ⬩ HIPAA Privacy Regulations (most well-known) ⬩ HIPAA Security Regulations Copyright © 2024 Gary Cacciatore Health Insurance Portability and Accountability Act of 1996 (HIPAA) (cont.) A.33 40 ◈ HIPAA Transactions and Code Set Regulations ⬩ Adopts standards for 8 electronic transactions and code sets to be used for those transactions ◈ HIPAA Privacy Regulations ⬩ “Pharmacies” are covered entities in the Act and must be in compliance with the regulations. ⬩ Notice and Acknowledgment ⬩ “Notice of privacy practices” Copyright © 2024 Gary Cacciatore Health Insurance Portability and Accountability Act of 1996 (HIPAA) (cont.) A.33 41 ◈ HIPAA Privacy Regulations ⬩ Use and disclosure of Protected Health Information (PHI) ⬩ Patient-identifiable information ⬩ Pharmacies may use PHI for treatment, payment, and health care operations without authorization from the patient ⬩ All other uses require authorization from the patient Copyright © 2024 Gary Cacciatore Health Insurance Portability and Accountability Act of 1996 (HIPAA) (cont.) A.33 42 ◈ HIPAA Privacy Regulations ⬩ Business Associates (BA) ⬩ Persons or entities, other than members of a pharmacy‘s workforce, who perform a function or service on behalf of the pharmacy ⬩ Contracts required with outside BAs Copyright © 2024 Gary Cacciatore Health Insurance Portability and Accountability Act of 1996 (HIPAA) (cont.) A.33 43 ◈ Patient Rights ⬩ Access ⬩ Patients have a right to inspect and obtain a copy of their PHI. ⬩ HIPAA requires compliance within 30 days of request, but Texas Board of Pharmacy rules require compliance within 15 days Copyright © 2024 Gary Cacciatore Health Insurance Portability and Accountability Act of 1996 (HIPAA) (cont.) A.33 44 ◈ Patient Rights ⬩ Amendments ⬩ Patients have a right to amend PHI or records containing PHI held by a covered entity. ⬩ Pharmacies must comply within 60 days of request. ⬩ Accounting ⬩ Patients have a right to an accounting of disclosures of PHI made by the pharmacy Copyright © 2024 Gary Cacciatore Health Insurance Portability and Accountability Act of 1996 (HIPAA) (cont.) A.34-35 45 ◈ Minimum amount of information disclosed to accomplish intended purpose ◈ Must have policies and procedures to protect from accidental disclosure of PHI ◈ Unintended “incidental” disclosures not a violation of the rules as long as reasonable safeguards are in place ◈ Privacy Official required ◈ Enforced by Office of Civil Rights (OCR) Copyright © 2024 Gary Cacciatore Health Insurance Portability and Accountability Act of 1996 (HIPAA) (cont.) A.35-36 46 ◈ HIPAA Security Regulations ⬩ Sets standards for administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of PHI ⬩ Business Associate (BA) Contracts ⬩ Business associates must comply with security regulations. Copyright © 2024 Gary Cacciatore Health Insurance Portability and Accountability Act of 1996 (HIPAA) (cont.) A.36-37 47 ◈ HITECH Act Provisions ⬩ Makes the administrative, physical, and technical safeguards of the HIPAA security regulations directly applicable to BAs ⬩ Breach notifications ⬩ Accounting of disclosures ⬩ Penalties and enforcement Copyright © 2024 Gary Cacciatore HIPAA Enforcement 48 ◈ After many years of relatively little or minor enforcement, in the last several years OCR has been taking significant enforcement actions for HIPAA violations. ◈ Many of the most serious actions are from breaches due to stolen or lost devices such as laptops, flash drives, etc. containing PHI. ⬩ Lesson – All devices with PHI should be encrypted. Copyright © 2024 Gary Cacciatore Significant HIPAA Enforcement Actions 49 ◈ Texas Health and Human Services Commission (Nov. 2019) ⬩ $1.6 million fine for allowing patient names, birthdates, SS numbers and treatment information to be accessed over the Internet ◈ Sentara Hospitals (Nov. 2019) ⬩ $2.175 million fine for failure to properly notify HHS of a breach of unsecured PHI Copyright © 2024 Gary Cacciatore Significant HIPAA Enforcement Actions (cont.) 50 ◈ The University of Texas M.D. Anderson Cancer Center (Jun. 2018) ⬩ $4.3 million fine for theft of an unencrypted laptop from the residence of an MD Anderson employee and the loss of two unencrypted universal serial bus (USB) thumb drives containing the unencrypted electronic protected health information (ePHI) of over 33,500 individuals ◈ Anthem (Health Insurer) (Oct. 2018) ⬩ $16 million fine for largest health care data breach in U.S. History Copyright © 2024 Gary Cacciatore Significant HIPAA Enforcement Actions (cont.) 51 ◈ Children’s Medical Center of Dallas (Feb. 2017) ⬩ $3.2 million fine for loss unencrypted, non-password protected device containing the ePHI of approximately 3,800 individuals and theft of unencrypted laptop ◈ Rite Aid Pharmacy (Jun. 2017) ⬩ $1 million fine for disposing prescriptions and labeled pill bottles containing individuals’ identifiable information in industrial trash containers that were accessible to the public Copyright © 2024 Gary Cacciatore Texas Privacy Laws (Texas “HIPAA”) A.37-38 52 ◈ ◈ ◈ ◈ ◈ ◈ ◈ Covered entities (expanded from federal statute) Additional restrictions on the use and disclosure of PHI More stringent training requirements Provision of Electronic Health Records (EHRs) Increased penalties Enforcement Breach notification requirements for all Texas businesses Copyright © 2024 Gary Cacciatore