Federal Food, Drug, and Cosmetic Act PDF

**FEDERAL FOOD, DRUG, AND COSMETIC ACT** **I. 1914: Harrison Narcotic Act (P.L. 223)** 1\. This act established a record keeping requirement for the receipt and dispensing of opium or coca leaf products. 2\. A tax was assessed, also, for the dispensing of these products. 3\. Physicians allowed...

**FEDERAL FOOD, DRUG, AND COSMETIC ACT** **I. 1914: Harrison Narcotic Act (P.L. 223)** 1\. This act established a record keeping requirement for the receipt and dispensing of opium or coca leaf products. 2\. A tax was assessed, also, for the dispensing of these products. 3\. Physicians allowed to prescribe these products in the course of legitimate treatment to patients other than drug addicts. 4\. The possession of narcotics without a prescription became **illegal**. **II. Federal Food, Drug, and Cosmetic Act of 1938** **A. Scope and Purpose** 1\. The FDA has the primary responsibility of enforcing the FD&C Act 2\. The Sulfanilamide Disaster led to the Act's passage 3\. Originally, only required: a\. Drugs to be proven safe not efficacious b\. Directions for Use c\. Adequate Warnings 4\. Today, designed to Protect the Public Health by requiring: a\. Safe, effective, and properly labeled drugs b\. Safe and properly labeled food and cosmetic preparations c\. Current Good Manufacturing Practices (CGMP) for certain entities like manufacturers and 503(b) outsourcing compounding pharmacies d\. Prescription drugs dispensed to an individual only pursuant to a **prescription** or administered directly by a physician or other authorized prescriber e\. Drug prescriptions be refilled only as authorized f\. Specific labeling for both prescription and nonprescription drugs g\. Dispensing a drug for distribution in violation of the Act's labeling requirements is misbranding2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 9 300759697v1 h\. Drugs containing filthy, putrid, and decomposed substances and drugs packed and held under unsanitary conditions be deemed adulterated i\. The FDA is authorized to perform limited inspections of pharmacies in certain circumstances j\. Manufactures or repackagers of drugs must register with the FDA 5\. The FD&C Act began the approval process for new drugs a\. The process requires a **New Drug Application** (NDA) b\. The 1938 Act provided a "grandfather clause" exempting certain drugs on the market prior to the act. \(1) Few exist on the market today \(2) The majority of those that do exist have obtained approval via an NDA or an Abbreviated New Drug Application (ANDA) **B. Durham-Humphrey Amendment (1951)** 1\. Defined Prescription Drugs "**Legend Drugs**" to distinguish from OTCs 2\. Restricted the sale of such drugs to prescription by a licensed practitioner 3\. Authorized refills on prescriptions **C. Kefauver-Harris Amendment (1962)** 1\. Triggered by the Thalidomide Disaster 2\. Increase scrutiny on safety 3\. First to require evidence of effectiveness before marketing 4\. Defines Current Good Manufacturing Practices (CGMP) a\. Minimum requirements for the methods, facilities or controls used in manufacture, processing, packaging, or holding of a drug product. b\. Apply to Manufactures and only certain pharmacies engaged in: \(1) 503(b) Outsourcing Compounding Pharmacy \(2) Hospital Repackaging \(3) Pharmacy Chain Distribution Center that Repackages2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 10 300759697v1 5\. Added informed consent requirement 6\. Prescription drug advertising is regulated by the FDA. Nonprescription (OTC) advertising is regulated by the Federal Trade Commission (FTC). **D. Further Amendments to the Act** 1\. The Medical Device Amendment (1976) a\. Definition of Device \(1) Device is defined as an instrument, apparatus, implant, etc. \(2) **No Chemical Action** b\. Three Classes \(1) Class I -- Least Regulation \(a) Needles, \(b) Scissors, \(c) Stethoscopes, and \(d) Toothbrushes \(2) Class II -- Must meet performance standards \(a) Insulin Syringes \(b) Electric Heating Pads \(c) Thermometers \(3) Class III -- Must have Premarket Approval because they are life supporting or life sustaining \(a) Pacemakers; \(b) Replacement Heart Valves 2\. The Drug Price Competition and Patent Term Restoration Act of 1984 a\. Extended the ANDA to generics, thereby making generic approval easier by: \(1) Not requiring proof of safety and efficacy through clinical trials2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 11 300759697v1 \(2) Only need to show the drug is bioavailable and bioequivalent to the innovator drug b\. Extended Patent Life for Brand Drugs \(1) A patent is the grant of a property right to the inventor issued by the Patent and Trademark Office of the United States. \(2) The life of the patent is 20 years from the date of first filing of the patent application. \(3) Because manufacturers usually file for patent protection prior to product marketing, the effective term of the patent is less than 20 years. \(4) The Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417) provides manufacturers with an opportunity to extend the life of the patent for an additional 5 years. \(5) With the 5-year extension, the total patent life of the drug patent cannot exceed **14 years** from the approval date of the drug product. 3\. The Prescription Drug Marketing Act (PDMA) of 1987 a\. Bans the Sale of Drug **Samples** b\. Works to reduce health risks from Diversion of Prescription Drugs c\. States License Wholesale Distribution 4\. Orphan Drug Act a\. Encourages development of products used for rare diseases or conditions 5\. Drug Efficacy Study Implementation Program (DESI) a\. Tests the effectiveness of drugs approved from 1938-1962 6\. The Drug Quality and Security Act of 2013 (DQSA) a\. In 2012, a number of patients died or became ill from fungal meningitis. Investigation revealed they were caused by contaminated compounded products prepared by New England Compounding Center. This focused attention on some pharmacies that were engaging in large-scale, non-patient-specific preparation of sterile products.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 12 300759697v1 b\. DQSA contains two parts: \(1) The Drug Supply Chain Security Act, which helps track products throughout distribution using a database \(2) The Compounding Quality Act, which describes the conditions under which certain compounded human drug products are entitled to exemptions from the Food, Drug and Cosmetic Act (FDCA), including exemptions from: \(a) Compliance with CGMP; \(b) FDA required labeling; and \(c) FDA approval prior to marketing. c\. The Compounding Quality Act identifies two types of compounders, who do not need to register as manufactures: \(1) 503A Traditional Compounding Pharmacies \(2) 503B Outsourcing Facilities d\. The following describes the conditions for a traditional compounding pharmacy (Section 503A) to avoid being construed as a manufacturer for purposes of FDA registration and for the compounded product to remain exempt from the FDA's CGMP, Labeling, and Approval requirements: \(1) Compounding (sterile and nonsterile) can occur subsequent to a prescription order only. Pharmacies: \(a) Cannot compound **large quantities** in advance \(b) Cannot compound drugs that were withdrawn from market due to safety issues (e.g. Vioxx) \(c) Cannot sell compounded products to anyone other than the patient. Cannot compound for "office use" \(d) Cannot compound copies of commercially available drugs \(e) To be considered a compounding activity, a proper PATIENT -- PRESCRIBER -- PHARMACIST relationship must exist \(f) Must comply with United States Pharmacopeia standards2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 13 300759697v1 \(g) A licensed practitioner must complete the compounding e\. A 503B outsourcing facility must comply with the FDA's CGMP, but its products may remain exempt from the FDA's Labeling and Approval requirements. \(1) 503B Outsourcing Facilities: \(a) Will be inspected by FDA according to a risk-based schedule, and \(b) Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound. \(c) No prescription is required and "office use" of compounded products is allowed. \(d) A pharmacist must supervise the compounding. \(e) No limits are placed on the amounts that can be compounded, but distribution to a wholesaler is prohibited \(f) May choose to register with the FDA **III. Product Regulation** **A. Definition of a Drug** 1\. The FD&C defines drug as: a\. Articles recognized in the official United States Pharmacopeia or other listed reference; b\. Articles intended for use in the **diagnosis**, cure, mitigation, treatment, or prevention of disease, in man or other animals (this is also known as the therapeutic or disease claim); c\. Articles (other than food) intended to affect the structure of any function of the body of man or other animals; 2\. Intended Use a\. The FDA looks at various documentation from the manufacturer to determine whether it will regulate a product as a drug:2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 14 300759697v1 \(1) Labeling for the product, websites, promotional pamphlets, and other marketing materials. \(2) The **intent** of the manufacturer or distributor is key to determining whether a particular item is a drug. 3\. Legend Drugs a\. Defined as a drug intended for use by man which because of its toxicity or other potential harmful effect, or other method of use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug. b\. Bulk Prescription Containers must include: \(1) The name and address of the manufacturer, packer, or distributor \(2) The established name of the drug product \(3) Ingredient Information \(4) If for other than oral use, the names of all inactive ingredients and route of administration \(5) The quantity in terms of weight or measure \(6) The net quantity of the container \(7) A statement of the recommended or usual dosage, or reference to the package insert \(8) "Rx only" or "Caution, federal law prohibits dispensing without a prescription" \(9) Identifying Lot or Control number \(10) Directions for the pharmacist regarding container usage \(11) The expiration date \(12) Adequate information for use 4\. New Drug a\. Defined as any drug that has not received general recognition by medical experts as being both safe and effective for the intended use. 5\. OTC Drug2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 15 300759697v1 a\. Defined as safe and effective for the general public b\. When considering OTC approval, the FDA expects the drug will generally have these characteristics: \(1) It can be adequately labeled so the consumer can self- diagnose, self-treat, and self-manage the condition being treated; \(2) No healthcare practitioner is needed for the safe and effective us of the product; \(3) The safety margin adequately ensures that the benefits of OTC availability outweigh its risks; \(4) The drug has a low potential for misuse and abuse. c\. Labeling required \(1) Active Ingredients \(2) **Purpose** \(3) Use(s), Indications \(4) Warnings \(5) Directions \(6) Other Information \(7) Inactive Ingredients d\. Pregnancy and nursing labeling (21 CFR §210.63) \(1) All products intended for OTC systemic absorption, unless exempt, shall contain in the Warning section the warning, "If pregnant or breast-feeding, ask a health professional before use." e\. Over-the-counter labeling of sodium content (21 CFR §201.64) \(1) The labeling of OTC products intended for oral ingestion shall contain the sodium content per dosage unit if the sodium content of a single maximum recommended dose of the product is 5 mg or more. f\. Calcium labeling (21 CFR §201.70)2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 16 300759697v1 \(1) The labeling of OTC products intended for oral ingestion shall contain the calcium content per dosage unit if the calcium content of a single maximum recommended dose of the product is 20 mg or more. g\. Magnesium labeling (21 CFR §201.71) \(1) The labeling of OTC products intended for oral ingestion shall contain the magnesium content per dosage unit if the magnesium content of a single maximum recommended dose of the product is 8 mg or more. h\. Potassium labeling (21 CFR §201.71) \(1) The labeling of OTC products intended for oral ingestion shall contain the potassium content per dosage unit if the potassium content of a single maximum recommended dose of the product is 5 mg or more. **B. Misbranding and Adulteration** a\. A drug is adulterated if: \(1) It consists in whole or in part of any filthy, putrid, or decomposed substance; \(2) It has been prepared, packed, or held under **unsanitary** conditions; \(3) It is manufactured contrary to Good Manufacturing Practice standards \(4) The container is made of poisonous or deleterious substances that may leech into the contents \(5) It contains an unsafe color additive \(6) Its strength, purity, or quality varies from that which it purports to be or is listed in the official compendial -- May also be misbranding \(7) It is a drug and any substance has been added to it to reduce its quality or strength. \(8) PA includes the following: \(a) Exposure to fire, water, or extreme temperatures b\. A drug is misbranded if:2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 17 300759697v1 \(1) Sold, dispensed, or distributed in violation of the labeling requirements of the FD&C \(2) Its label is false or misleading \(3) It's not labeled and packed according to compendial standards \(4) The package or drug is misleading in the way it is filled or formed or is imitative of another drug \(5) The drug is subject to deterioration and the label does not bear such a warning \(6) The drug/device is health-endangering if used in the manner suggested by the labeling; \(7) It is not packaged in accordance with the Poison Prevention Packaging Act (PPPA) of 1970 \(8) Drugs dispensed via prescription if at any time prior to dispensing the label of the drug failed to state at a minimum, "Rx only" \(9) If a pharmacist sells a drug without a prescription or refills without authorization. 2\. Expiration Dates a\. For non-sterile solid and liquid pharmaceutical products repackaged into unit-dose or single-unit containers, pharmacists must: \(1) affix a "**beyond-use date**" that is "one year or less" \(2) unless stability data or the manufacturer's labeling indicates otherwise b\. For ordinary prescription vials the beyond-use date is not later than: \(1) The expiration date on the manufacturer's container; or \(2) Once year from the date the drug is dispensed, whichever is earlier. **C. Dietary Supplements** 1\. A product intended to supplement the diet, which contains any of the following: a\. Vitamin;2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 18 300759697v1 b\. Amino Acid c\. Mineral; d\. Herb; e\. Dietary Substance for use by man to supplement the diet by increasing the dietary intake; f\. Concentrate, metabolite, constituent, extract or combination the above. 2\. The following structure/function claims are permissible for use with dietary supplements: a\. Description of the role of the dietary supplement in affecting the structure or function of the body. That is, "calcium supplement with vitamin D for strong bones; helps maintain a healthy heart." b\. Identification of the mechanism utilized by the dietary supplement to maintain structure and function. That is, "fiber maintains bowel regularity." c\. Description of the benefit from consumption of the supplement. That is, "helps body adapt and promote physical performance." d\. Description of a benefit of a classic nutrient deficiency disease as long as the prevalence of the disease in the United States is stated in the claim. 3\. If a dietary supplement label contains one of the permissible claims, the label must include the following statement, "**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**." 4\. Manufacturers must notify the FDA at least 75 days prior to marketing and include in the notification the manufacturer's basis for concluding that the dietary supplement "will reasonably be expected to be safe." **D. Cosmetics** 1\. The Food, Drug, and Cosmetic Act defines cosmetics as articles intending for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or function. 2\. Cosmetics that are drug products2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 19 300759697v1 a\. Cosmetics that are intended to treat or prevent disease or alter a body function are considered drug products. b\. The key in determining whether a product is a cosmetic or a drug- cosmetic product is the products claim. Does the label claim that the product will treat or prevent disease? **E. Homeopathic drug products and herbal products** 1\. Defined as "any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States, an addendum to it, or its supplements." 2\. Homeopathy is the practice of treating the syndromes and conditions which constitute disease with remedies that have produced similar syndromes and conditions in healthy subjects. 3\. Homeopathic medicine stimulates the person's natural defense system, helps heal illness, and raises the general level of health. **F. Generics** 1\. **Single source** products are drug products that are the only product approved by the FDA for that active ingredient, dosage form, route of administration, and strength. 2\. **Multisource** drug products are drug products that are manufactured by several manufacturers. 3\. **Pharmaceutical equivalence** refers to drug products with the same active ingredients, same dosage form, same route of administration, and identical in strength or concentration. These products must meet the same compendia standards for purity, quality, strength, and labeling. 4\. **Therapeutic equivalents** are those products that are pharmaceutical equivalents and bioequivalent. The FDA utilizes the following criteria to determine if a drug product is a therapeutic equivalent: a\. Approved for safety and effectiveness b\. Pharmaceutical equivalent c\. Bioequivalent d\. Adequate labeling e\. Manufactured in compliance with Good Manufacturing Practices.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 20 300759697v1 5\. **Bioavailability** is the rate that the active ingredient of the drug product is absorbed from the product and made available to the site of action. 6\. **Bioequivalent** drug products are products that are pharmaceutically equivalent that provide the same results of drug delivery with the same pharmacokinetic properties. 7\. **Reference Listed Drug** (RLD) is the standard against which all generic drug products are compared. The RLD has filed a New Drug Application that has been approved by the FDA. Upon expiration of the RLD patent, generic manufacturers can file an Abbreviated New Drug Application for approval of their generic product. All bioavailability is measured against the information for the RLD product. The generic drug product must demonstrate that the drug product provides the same results as the RLD product through bioavailability studies. 8\. **Pharmaceutical Alternatives** are drug products that contain the same therapeutic moiety, but are different salts, esters, or complexes of that moiety, or are different dosage forms or strengths. Orange Book -- Approved drug products with therapeutic equivalence evaluations 9\. Multisource Drug Products equivalence Codes a\. A -- products are considered to be therapeutically equivalent to other pharmaceutically equivalent products. These products utilize the designation of: \(1) AA -- products in conventional dosage forms not presenting bioequivalence problems \(2) AB -- products with actual or potential bioequivalence problems that have been resolved in vivo or in vitro b\. B -- products are not therapeutically equivalent. The problem usually is with the dosage forms not the active ingredients in the drug products. c\. See PA Generic Substitution Law, infra: \(1) AA and AB -- Drug Products considered equivalent --Can Substitute in PA, unless it has a narrow therapeutic range -- Coumadin and Lanoxin (NTI Drugs) \(2) B -- Drug Products not substitutable.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 21 300759697v1 **G. Biological Product** a\. Vaccines, Various Toxoids, skin test substances, blood and blood products for transfusion b\. A manufacturer license issued by CBER (Center for Biologics Evaluation and Research) c\. Biosimilars -- Unique biological drugs from living organisms using recombinant technology. Highly similar to the reference product. **H. Veterinary Products** 1\. Must gain approval by New Animal Drug Application (NADA) 2\. If used in food producing animals then all edible products must be free of unsafe residues 3\. Flea Control Products a\. Topical -- EPA regulation b\. Oral -- FDA regulation **IV. Regulation of Pharmaceutical Products** Premarket Requirement Indication on Label Post market Review Regulation of Advertising CGMP Required Prescription Drugs **Clinical Testing;** **FDA Approval** **Yes Yes FDA Yes** OTC Drugs **Conform with FDA** **OTC Monograph** **Yes Yes Federal Trade** **Commission (FTC)** **Yes** Homeopathic Drugs **Conform with** **Homeopathic** **Pharmacopeia** **Yes Yes FDA (RX) FTC** **(OTC)** **Yes** Dietary Supplements **FDA Notification No Yes FTC Yes** **V. Drug Approval Process** **A. Before a new drug can be marketed, federal law requires submission and** **approval and this process begins with:** 1\. A sponsor submitting information on an Investigation New Drug (IND) approval which includes: a\. Name of drug b\. Composition c\. Methods of manufacturing d\. Quality Control2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 22 300759697v1 e\. Preclinical nonhuman studies f\. Pharmacological, Pharmacokenetic, and toxicology studies g\. Outline of clinical studies proposed 2\. If the FDA does not reject the IND within 30 days of submission, clinical testing on humans may begin with: a\. Phase I -- Small number of **healthy** individuals (20-80), to determine the pharmacology of the drug and its toxicology -- Not Efficacy b\. Phase II -- Limited number of people (100-300) who actually have the disease to determine efficacy c\. Phase III -- Lager Scale of affected individuals (1000-3000) \(1) If results are favorable the company then submits an New Drug Approval (NDA) d\. Phase IV -- Performed after drug has been granted FDA approval to monitor any reported serious side effects. **B. Expedited Approval** 1\. For Drugs used to treat serious life-threatening illnesses and that also provide a meaningful therapeutic advantage over existing treatments. **VI. Drug Recalls** **A. Three Classes** 1\. Class I -- Reasonable possibility that the use of or exposure to a product will cause either **serious adverse effects** on health or death. 2\. Class II -- Use of or exposure to product may cause temporary or medically reversible adverse effects on health or where the probability of serious adverse effects on health is remote. 3\. Class III -- use of or exposure to product is not likely to cause adverse health consequences. **B. Market Withdrawal** 1\. Product removed from the market due to a minor violation is not subject to FDA legal action **VII. FDA Inspections**2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 23 300759697v1 1\. The inspection must: a\. Be conducted at a reasonable time b\. In a reasonable manner; and c\. Be reasonably limited. 2\. The inspector needs to present a\. Credentials; and b\. Notice of Inspection **VIII. Unlabeled or Unapproved Indications** **A. Approved Drugs may be used for unlabeled Indications** 1\. Unapproved medical devices may be used by a physician in Life Threatening Situations, where: a\. no alternative is available, and b\. sufficient time to seek **approval** is not possible, but c\. must substantiate use at a later time. 2\. Although discouraged by the FDA, prescribers may prescribe the drug for these unofficial indications and pharmacies, using their professional discretion, may dispense such prescriptions. **B. Investigational Drugs** 1\. May be used in the general population provided that: a\. Treatment Protocol is submitted to the FDA b\. Serious or immediately life-threatening disease c\. No comparable or satisfactory alternative d\. The drug must be an approved investigational new drug being used in a controlled clinical trial and the sponsor of the clinical trial is seeking approval. **IX. Packaging** **A. Tamper Evident Packaging**2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 24 300759697v1 1\. OTC's must be packaged in a tamper evident container a\. One or more indicators or barriers to entry must exist to provide evidence of tampering b\. The Packaging should be difficult to duplicate c\. Two-Piece hard gelatin capsules must be sealed with tamper-evident technology **B. Child Resistant Packaging** 1\. Poison Prevention Packaging Act requires Child resistant caps on all legend drugs a\. 80% under 5 years of age cannot open and 90% of adults can open 2\. Physician or Patient (or head of household) may request non-child resistant packaging a\. Request may be in writing or made orally b\. Several drug products are exempted from child-resistant packaging: \(1) Products in aerosol containers intended for inhalation therapy. \(2) Aspirin and acetaminophen effervescent tablets or granules containing not more than 15% of either drug. \(3) Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more than 8 g of erythromycin. \(4) Erythromycin ethylsuccinate tablets in packages containing not more than 16 g of erythromycin. \(5) Anhydrous cholestyramine in powder form. \(6) Colestipol in powder form containing not more than 5 g per packet. \(7) Isosorbide dinitrate sublingual and chewable products in dosages of 10 mg or less. \(8) Sublingual **nitroglycerin** tablets. \(9) Oral contraceptives cyclically administered in a manufacturer's mnemonic (memory-aid) packages (e.g. a Dialpak).2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 25 300759697v1 \(10) All hormone replacement therapy (HRT) products that rely solely on the activity of one or more progestogen or estrogen substances. \(11) Potassium supplements in unit dose forms, including individually wrapped effervescent tablets, unit-dose vials of liquid potassium, and powdered potassium in unit-dose packets, containing not more than 50 mEq per unit dose. \(12) Prednisone tablets containing not more than 105 mg per package. \(13) Methylprednisolone tablets containing not more than 84 mg per package. \(14) Betamethasone tablets containing not more than 12.6 mg per package. \(15) Mebendazole tablets containing not more than 600 mg per package. \(16) Pancrelipase preparations. \(17) Sacrosidase (sucrase) preparations in a solution of glycerol and water. c\. Some OTC products must comply with the PPPA's child resistant packaging: \(1) Loperamide \(2) Diphenhydramine \(3) Acetaminophen \(4) Mouthwashes \(5) Naproxen **X. Tax-Free Alcohol** 1\. May be used for: a\. Scientific; b\. Medicinal and Mechanical Purposes; and c\. In the treatment of patients2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 26 300759697v1 2\. May not be used for: a\. Beverages; or b\. Foods **XI. Ipecac Syrup** 1\. Available for sale without a prescription provided that: a\. It is packaged in a quantity of 30 milliliters; and b\. Its label bears: \(1) A statement in red letters, "For Emergency use to cause vomiting in poisoning. Before using, call physician, the Poison Control Center, or hospital emergency room immediately for advice." \(2) A warning -- "Warning -- Keep out of reach of Children. Do not use in unconscious persons. Ordinarily this drug should not be used if strychnine, corrosives such as alkalies (lye) and strong acids, or petroleum distillates such as kerosene, gasoline, coal oil, fuel oil, paint thinner, or cleaning fluid have been ingested." \(3) Usual Dosage: 1 tablespoon (15 milliliters) in persons over 1 year of age. **XII. United States Pharmacopeia Storage Temperature Guidelines** **A. Temperature Ranges** 1\. Cold -- not exceeding 8ºC (46ºF) 2\. Cool --between 8 and 15ºC (46-59ºF) 3\. Room temperature -- temperature prevailing in work area 4\. Controlled room temperature -- maintained between 15 and 30ºC (58-86ºF) 5\. Warm -- between 30 and 40ºC (86-104ºF) 6\. Excessive heat -- above 40ºC (104ºF) 7\. Refrigerator -- maintained between 2 and 8ºC (36-46ºF) 8\. Freezer -- maintained between -20 and -10ºC (-4 and 14ºF)2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 27 300759697v1 9\. Expired products should be removed from the operating stock in the pharmacy to prevent dispensing of expired products. **XIII. United States Pharmacopeia Chapters 785, 797, 800, and 825** **A. USP 795: Nonsterile Compounding** 1\. Provides standards for compounding quality nonsterile preparations. 2\. The chapter describes requirements for the compounding process, facilities, equipment, components, documentation, quality controls and training. 3\. General Chapter \ also provides general guidelines for assigning beyond-use dates to nonsterile preparations. **B. USP 797: Sterile Compounding** 1\. A national standard for the process, testing and verification of any compounded sterile preparations. 2\. It provides guidance on preventing microbial contamination and other variances in compounded sterile products regardless of setting (for example, hospitals, community pharmacies) and who is performing the compounding (pharmacists, nurses, pharmacy technicians, or others). 3\. USP Chapter \ sets forth criteria for compounding the following sterile products: a\. Preparations prepared according to the manufacturer's labeled instructions where the original contents may be exposed to contamination. b\. Preparations containing nonsterile ingredients or nonsterile components and devices that must be sterilized before administration. c\. Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that possess either of the above two characteristics and which may include baths and soaks for live organs or tissue, implants, inhalations, injections, powders for injection, irrigations, metered sprays, and ophthalmic and otic preparations. **C. USP 800: Hazardous Drugs** 1\. According to the National Institute for Occupational Safety and Health (NIOSH), a hazardous drug exhibits one or more of the following six characteristics in humans or animals: a\. Carcinogenicity2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 28 300759697v1 b\. Teratogenicity or other developmental toxicity c\. Reproductive toxicity d\. Organ toxicity at low doses e\. Genotoxicity 2\. Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria 3\. The standard applies to all healthcare personnel (i.e., physicians, nurses, veterinarians, pharmacists and technicians) and all healthcare facilities where hazardous drugs are handled or manipulated, including their storage and distribution--- with a goal of preventing and/or limiting exposure. 4\. USP 800 is designed to complement both USP 795 (Nonsterile Preparations) and USP 797 (Sterile Preparations). 5\. There is no acceptable level of personnel exposure to Hazardous Drugs. 6\. Personnel a\. Each entity must have a designated person who is qualified and trained to be responsible for \(1) developing and implementing appropriate procedures; \(2) overseeing entity compliance with this chapter and other applicable laws, regulations, and standards; \(3) ensuring competency of personnel; and \(4) ensuring environmental control of the storage and compounding areas. b\. All personnel who handle HDs are responsible for understanding the fundamental practices and precautions and for continually evaluating these procedures and the quality of final HDs to prevent harm to patients, minimize exposure to personnel, and minimize contamination of the work and patient-care environment. 7\. Facility design -- No Positive Pressure Areas a\. Hazardous drugs shall not be stored, unpacked, compounded or otherwise manipulated in an area that is positive pressure relative to the surrounding areas, so hazardous drugs must be stored in negative or normal/neutral pressure,2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 29 300759697v1 b\. A laminar air flow workbench (LAFW) or compounding aseptic isolator (CAI) shall not be used for the compounding of a hazardous drugs. c\. All hazardous drug compounding shall be done in a separate area designated for hazardous drug compounding. 8\. Garb a\. Details for personal protective equipment are based on the function being performed b\. Gloves, gowns, head, hair and sleeve covers, eye and face protection, respiratory protection. 9\. Cleaning a\. Deactivation and disinfection with an oxidizer, cleaning with a germicidal detergent, and disinfection with sterile alcohol. 10\. Administering a\. Closed-system drug-transfer devices should be used when compounding and shall be used when administering. **D. USP 825 -- Radiopharmaceuticals** a\. USP 825 outlines the minimum standards for preparing, compounding, dispensing, and repackaging sterile and nonsterile radiopharmaceuticals for humans and animals. **E. EPA 2019 Disposal Rule** 1\. Impacts all pharmacies and healthcare facilities including those authorized to distribute, sell, or dispense drugs: a\. Bans intentional disposal of hazardous waste pharmaceuticals via toilets, sinks, drains \(1) E.g., flexible collodion, insulin, nasal sprays, scopolamine, silver nitrate, witch hazel \(2) Exempts OTC nicotine gums, patches, and lozenges from hazardous waste list b\. Creates two categories of pharmaceutical waste: \(1) potentially creditable waste (unused or un-administered and unexpired less than 1 year past expiration date)2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 30 300759697v1 \(2) non-creditable waste (removed from original container, returned after pharmacy has received payment, more than 1 year past expiration, refused by patient after attempt to administer, free samples, unused investigational drugs) **XIV. Bar code rule (21 CFR 201.25)** 1\. Requires bar coding, consisting of, at a minimum, the National Drug Code (NDC) number, on certain products administered to patient in hospitals in an effort to reduce medication errors. This rule applies to manufacturers, repackers, relablers, and private label distributors of the following products: a\. Prescription drugs, except physician drug samples, allergenic extracts, intrauterine devices, medical gases, radiopharmaceuticals, low density form fill, and seal containers that are not packaged with an over wrap. b\. Biological products. c\. Over-the-counter products dispensed pursuant to an order and that are commonly used in hospitals. **XV. National Drug Code (NDC)** 1\. The NDC is a numbering system that aids in identifying a drug product. Third party payers also employ NDC numbers to identify products for reimbursement. 2\. The NDC of a specific drug product contains ten or eleven digits. For example, a number may be: 1 0 7 4 0 1 2 8 0 4 Manufacturer ID of specific drug ID of package 3\. All prescription drugs marketed in the United States must have NDC numbers. 4\. The NDC number does not have to appear on individual dosage units nor is there any federal law requiring that NDC numbers appear on prescription labels. **XVI. Unit Dose Packaging and Labeling** 1\. The FDA has issued guidelines as to what information should be on each unit-dose package. This information includes: a\. Generic name and trade name, if appropriate.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 31 300759697v1 b\. Quantity of active drug or drugs present (and the number of dosage units, if more than one). c\. Name of the manufacturer, packer, or distributer. d\. The repackager's lot number. e\. The expiration date. f\. Any other appropriate information concerning the specific drug (e.g. special storage requirements). **XVII. Risk Evaluation and Mitigation Strategy (REMS)** **A. REMS** 1\. A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. 2\. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. **B. Mifepristone** 1\. FDA approved a REMS program for mifepristone. The REMS includes the definition and requirements for a "certified" pharmacy. 2\. Mifepristone (Mifeprex and one generic) and misoprostol (Cytotec) were approved by the FDA in 2000 to be used together for pregnancy termination. Now that the certification process has been approved, pharmacies can achieve certification by agreeing to a number of requirements. 3\. Mifepristone will become available at some FDA-certified retail pharmacies,subject to state laws and regulations. **XVIII. Pregnancy and Lactation Labeling** **A. Pregnancy (including labor and delivery)** 1\. The FDA requires the removal of all pregnancy categories A, B, C, D, and X from all drug product labeling. 2\. If the drug has a scientifically acceptable pregnancy exposure registry for the drug, the labeling must contain a specified statement about the registry. 3\. Label must contain a summary of the drug's risks during pregnancy.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 32 300759697v1 4\. If the drug is systemically absorbed the summary should include relevant information to help health care providers and counsel women, including: a\. disease-associated maternal and/or embryo/fetal risk b\. dose adjustments during pregnancy and the postpartum period, c\. maternal adverse reactions, d\. fetal/neonatal adverse reactions, and/or e\. the effect of the drug on labor or delivery **B. Lactation** 1\. Label must contain a summary of the drug's risks during lactation 2\. If the drug is systemically absorbed the summary must include: a\. relevant information on the presence of the drug in human milk b\. effects of the drug on the breast-fed child, c\. effects of the drug on milk production d\. ways to minimize drug exposure in the breast-fed child e\. available interventions for monitoring or mitigating the adverse reactions f\. pertinent information about the data that are the basis for the labeling. g\. a risk and benefit statement, unless breastfeeding is contraindicated during drug therapy. **C. Females and males of Reproductive Potential** 1\. Labeling must include relevant information when: a\. pregnancy testing or contraception is required or recommended before, during or after drug therapy; or b\. there are human or animal data that suggest drug-associated fertility effects.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 33 300759697v1 **THE CONTROLLED SUBSTANCES ACT** **I. Background of the Controlled Substances Act** 1\. The Federal law that regulates controlled substances is the Controlled Substance Act (CSA) of 1970. 2\. The CSA was the first Federal legislation to control addicting drugs. 3\. Congress Enacted the CSA under its authority to regulate commerce 4\. The Courts have the final say in interpreting the CSA **A. Controlled Substances** 1\. The CSA regulates all aspects of drugs which are subject to or have potential for abuse or physical or psychological dependence. 2\. CSA includes not only narcotic drugs but also non-narcotic stimulants, depressants, and hallucinogenic drugs. **B. Drug Enforcement Administration (DEA)** 1\. Part of the U.S. Department of Justice and Federal Agency responsible for administration and enforcement of CSA. 2\. Implements regulations regarding controlled substances and regulated chemicals (Title 21, Code of Federal Regulations ("CFR") Part 1300 to end). **C. Method of Control Under the CSA** 1\. The DEA does not routinely inspect pharmacies for controlled substances violations (state agencies do so). 2\. Control is obtained through Registration of all persons in chain of possession. a\. Manufacturers b\. Distributors c\. Dispensers \(1) Prescribers \(2) Pharmacies d\. Importers e\. Exporters2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 34 300759697v1 **II. Schedules of Controlled Substances** Schedule Currently Accepted Medical Use Abuse Potential Severity of Physical/Psych Dependence I. None High Lack Safety Examples: Heroin, Marijuana, LSD, Methaqualone, Gamma Hydroxybutyric Acid (GHB), Methcathinone, MDMA \*Not Available for prescribing. \*Investigational drugs. \*DEA does allow for research involving Schedule I substances. This Requires a separate registration as research facility. II Yes High Severe Examples: Hydrocodone (effective October 6, 2014), Morphine, Codeine, Cocaine, Oxycodone, Opium, Fentanyl, Methylphenidate, Methamphetamine \*Substances containing more than 90 milligrams/dosage unit or 18 mg/ml of Codeine are CII's. III Yes Moderate Low/Moderate (Physical) High (Psychological) Examples: Anabolic Steroids, Tylenol w/Codeine, Butalbital, Chlorphentermine \*Buprenorphine (Subutex) and Buprenorphine/Naloxone (Suboxone) previously dispensed in Special Treatment Centers only, but now any pharmacy may fill Prescriptions for these. \*Dronabinol (Marinol) is now a CIII in PA. \*Xyrem (the GHB-containing pharmaceutical product is a Schedule III. IV Yes Low Limited Examples: Alprazolam, Chloral Hydrate, Diazepam, Lorazepam, Phentermine, Temazepam, Zolpidem; Carisoprodol (Soma); Tramadol (Ultram) V. Yes Low Limited Examples: Lomotil, Codeine Preparations (Anti-Tussive), Opium Preparations, etc. \* 2mg/ml of Codeine is the cutoff for CV (Title 21, under Part 1308) (www.usdoj.gov/dea/pubs/scheduling.html)2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 35 300759697v1 **A. Scheduling Issues** 1\. The DEA through the Attorney General Determines Classifications based on binding input regarding scientific matters from the Department of Health and Human Services. 2\. Controlled Substance Analogs are treated as C-I's or C-II's and are similar to a controlled substance: a\. In Chemical Structure; b\. In CNS Effect; or c\. In a person's representation or intention of such effect. 3\. Schedule II substances in suppository form become Schedule III substances. **III. Registration of Pharmacy with DEA** **A. Who** 1\. A separate registration with the DEA is required for every pharmacy that dispenses controlled substance. 2\. If a person owns and operates more than one pharmacy, each place of business must be registered. 3\. The DEA does not register pharmacists; pharmacists obtain a license to practice from state. **B. Classification** 1\. Pharmacies, Hospitals and Physicians register as dispensers. 2\. Pharmacies are permitted to manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance (CII-CV) without registering as manufacturer, so long as it is in a portion not exceeding 20% of the complete solution or compound. 3\. If one pharmacy buys and supplies the other stores in a chain -- that main output pharmacy must be registered as a distributor. **C. Initial Registration** 1\. Pharmacies seeking to register for first time must request DEA Form-224. A Hospital does not need to separately register: 1\. Decentralized Pharmacy Services; or 2\. Satellite Pharmacies If Part of Same Structure. To avoid and "imminent hazard to public safety" the AG may place a drug into schedule I without consulting the Secretary of the HHS.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 36 300759697v1 2\. The Certificate of Registration must be maintained at the registered location and kept available for official inspection. 3\. The DEA will accept an affidavit of Pharmacy License to Process the Application faster. **D. Renewal** 1\. Pharmacy registration must be renewed every three years. a\. Note: Upon initial registration each pharmacy will be assigned an expiration date which is roughly three years from the date of initial registration. That period is referred to as the initial registration period. b\. After the initial registration period, the registration shall expire 36 months from the initial expiration date. 2\. Every registered pharmacy will receive a renewal application approximately 60 days before the registration expiration date. 3\. Pharmacies seeking to renew registration use DEA Form-224a. 4\. DEA Form-224a will be automatically sent to the address on the current registration certificate. 5\. If renewal form is not received within 45 days before expiration of current certificate, the pharmacy should contact the Registration Unit of DEA. 6\. Manufactures and distributors must register every year due to volume. **E. Exemption from Registration** 1\. Individual Practitioners, Interns Residents or Foreign-Trained Physicians that are agents or employees of a hospital or other institution, may, administer, dispense, and prescribe controlled substances under the registration of the hospital or institution provided that: a\. Individual is acting within the usual course of professional practice; b\. Individual is acting within the scope of his/her employment; c\. Individual is authorized to dispense, administer, or prescribe by the jurisdiction in which he/she is practicing; d\. The institution by which the practitioner is employed verifies authorization to dispense, administer, or prescribe by the jurisdiction;2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 37 300759697v1 e\. The hospital designates a specific internal code number for each individual; and \(1) NOTE: The code number shall consist of numbers, letter, or a combination thereof and shall be a suffix to the institution's DEA registration number -- e.g., AP0123456-10 f\. The list of codes and respective practitioners is made available to other registrants and law enforcement agencies. 2\. Officials of: a\. Armed Services b\. Public Health Services c\. Bureau of Prisons d\. Law Enforcement 3\. Personal Medical Use a\. Any individual who has lawfully obtained for personal medical use may enter or depart the United States with a controlled substance provided that \(1) Controlled substance is in the original container; \(2) Individual makes a declaration to the customs official (1) that the controlled substance is for personal use and (2) providing the name and controlled substance symbol if it appears on the label. If it does not the name and address of the pharmacy or prescriber must be provided. b\. A United States resident may not import more than 50 dosage units. **F. The Drug Addiction Treatment Act of 2000 (DATA 2000)** 1\. Provides Exemption From Separate Registration For Prescribing And Dispensing Schedule II-V Controlled Substances Approved By The FDA for opioid use disorder (OUD) a\. Allows qualified physicians to dispense or prescribe specifically approved Schedule III, IV, and V narcotic medications for the treatment of opioid addiction in treatment settings other than the traditional Opioid Treatment Program (i.e., methadone clinic). 2\. **Practitioners no longer need an X waiver to prescribe medications for** **opioid use disorder.**2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 38 300759697v1 a\. Under the Consolidated Appropriations Act of 2023, all practitioners who have a current DEA registration that includes Schedule III authority may now prescribe buprenorphine for opioid use disorder if permitted by applicable state law. 3\. Pharmacy Automatically Exempted And May Dispense Qualifying Physician's Prescription Under its DEA Registration Number 4\. Suboxone and Subutex are approved for Opioid Addiction a\. Both are C-III's b\. NOTE: FDA permits the prescribing and dispensing of Suboxone and Subutex for Analgesic purposes. The theory being that prescribers can dispense for off-label purposes based on medical judgment. **G. Modification, Transfer and Termination of Registration** 1\. Modification of Business Name or Address a\. Requires DEA notification and DEA approval. 2\. Transfer of Business a\. A registrant transferring a pharmacy business to another registrant shall notify the DEA at least 14 days in advance of the proposed transfer and provide the following: \(1) Name, address, registration number and authorized business activity of the registrant discontinuing business and of the acquiring pharmacy; \(2) Whether the business activities will be continued at the location registered by the current owner or moved to a new location; and \(3) The date on which the controlled substances will be transferred to the acquiring pharmacy. b\. On the day of the transfer a complete inventory must be taken. c\. All records must be transferred as well **H. Denial, Revocation, or Suspension of Registration** 1\. The U.S. Attorney General has the authority to deny, suspend or revoke a DEA registration for any period of time upon a finding of: a\. Materially falsified application; Any unused DEA Forms must be returned to the DEA.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 39 300759697v1 b\. Conviction of a felony relating to a controlled substance; c\. Act which is inconsistent with Public Interest; or d\. Exclusion from participation in Medicaid or Medicare Program. 2\. If registration is revoked or suspended all controlled substances must be delivered to the nearest DEA field office. 3\. May Request/Need to Appear before the Board for a Hearing. **I. Death or Cessation of Business** 1\. Must notify the DEA immediately 2\. Records must be kept for two years **IV. Security Requirements** 1\. Pharmacies must keep Schedule II, III, IV, and V controlled substances in a locked cabinet or dispersed through the non-controlled stock in a manner to deter theft. **A. Controlled Substances Theft or Loss.** 1\. Notify the Police and DEA. a\. DEA must be notified in writing of any significant theft or loss within one business day. b\. Registrants must complete necessary documentation within 45 days. 2\. Complete DEA Form-106. a\. Name and Address b\. Date of Theft c\. DEA Registration Number d\. Contact Information for Police Called e\. Type of Theft f\. List Symbols or Codes Used to Mark Bottles g\. Missing Drugs **B. "Significant Loss" Must Be Reported.** Package seal on a controlled substance must provide notice of drug tampering. If investigation reveals no theft or loss then no DEA Form 106 need be filed. However, the registrant must notify DEA in writing to clarify why no 106 was filed after the initial call. Copies 1 and 2 of DEA Form 106 are sent to the DEA and Copy 3 is retained by the pharmacy.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 40 300759697v1 1\. CSA does not define the specific numerical quantity or percentage of loss, but the following factors should be considered: a\. Quantity of the controlled substance lost in relation to the type of business; b\. The Specific controlled substance lost c\. Whether the loss of the controlled substances can be associated with access to those controlled substance by specific individuals d\. A pattern of loss or whether the loss appears random, and whether efforts were taken to prevent the loss e\. Whether the controlled substance is one likely targeted for diversion f\. Local trends g\. Overriding factor is most often the business of the pharmacy. **C. In-Transit Loss.** 1\. Pharmacist responsibility to report using DEA Form-106. **D. Breakage/Spillage** 1\. Report using DEA Form-41 2\. "Wasting" 3\. Disposal of residual amounts of controlled substances left after administration to the patient is generally permitted, without submitting a separate DEA Form-41, so long as it is recorded in the Narcotic Record. Typically a witness is required. **E. Obligation to Report Diversion** 1\. There is general duty to report all diversion 2\. Co-Worker Diversion a\. Any employee who has knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer or the DEA. **V. Distribution and Disposal of Controlled Substances** **A. Distribution of Controlled Substances** Physician orders 60mg dose of meperidine Injection and it comes in a 75mg ampule. The nurse may waste the remaining 15 mg.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 41 300759697v1 1\. Pharmacies are permitted to distribute controlled substances to other registrants without registering as a distributor, so long as the total amount distributed is less than 5% of the total controlled substance dosage units per year. 2\. A Registered Pharmacy may distribute a Schedule II controlled substance to another registrant. The receiving registrant must issue a DEA Form-222 to the registrant distributing the drugs. 3\. To distribute a C-III-V controlled substances, the transfer must be documented in writing to show the drug name, dosage form, strength, quantity, date transferred, and name, address, and registration number to who distributed. 4\. Examples: a\. To another pharmacy or prescriber for purpose of general dispensing to patients. \(1) On the day of the transfer, a complete inventory must be taken, documenting the drug name, dosage form, strength, quantity, and date transferred. \(2) The distributions that a registered retail pharmacy makes to automated dispensing systems at long term care facilities for which the retail pharmacy also holds registrations do not count toward the 5% limit. b\. To another supplier or manufacturer. \(1) The 5% Rule does not apply if pharmacy is returning controlled substances back to the original supplier. \(2) The supplier or manufacturer is still required to issue a DEA Form 222 for CII's or document the transfer in writing for CIII-V. **B. Disposal of Controlled Substances** 1\. Once-A-Year DEA authorization for destruction. a\. A Registered Pharmacy must complete DEA Form-41. b\. Any Non-Registrant in possession of controlled substance make seek permission for disposal by preparing a letter requesting permission to destroy controlled substances, listing the name and address of the person, the name and quantity of each controlled substance, how the applicant obtained the substance, the name address, and registration The DEA must receive both DEA Form-41 and the prepared letter at least 14 days before the proposed destruction date. The DEA will notify registrant in writing.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 42 300759697v1 number, if known, of the person who possessed the controlled substances prior to the applicant. c\. In PA, contact DEP for instruction on destruction. d\. Authorization not required if law enforcement authority or regulatory agent is present. 2\. Instead of handling the disposal internally, most Pharmacies Distribute their controlled substances to Reverse Distributors for disposal of controlled substances. a\. 5% Rule distribution rule does not apply. b\. Pharmacy may forward to reverse distributors controlled substances at any time. c\. The reverse distributor must issue the Form-222 to the pharmacy for CII's. d\. The reverse distributor must submit DEA Form-41 to the DEA once the drugs have been destroyed.. 3\. "Blanket Authorization" for destruction. a\. The DEA issues "Blanket Authorizations" for destruction of controlled substances on a very limited basis. b\. The only registrants who the DEA issues this authorization to are associated with hospitals, clinics, or other registrants having to dispose of used needles, syringes, or other injectible objects only. 4\. The reason for the limited exception is there is a high probability that those objects have been contaminated by hazardous bodily fluids and destruction of the objects is in the best interest of all. **C. Record Keeping** 1\. The records involving the transfer or destruction of controlled substances must be kept readily available for two years for inspection and copying by the DEA. **VI. Prescription Order Requirements** 1\. Prescription -- An order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 43 300759697v1 2\. In other words, a Prescription does not include the common medication order found in institutional and hospital settings. **A. Who May Issue A Prescription?** 1\. A prescription for a controlled substances may be issued only by an individual practitioner1 who is: a\. Authorized to prescribe controlled substances by the jurisdiction in which the practitioner is licensed to practice; and b\. Registered with the DEA or exempted from registration (i.e., Public Health Service and Bureau of Prison physicians) 2\. A prescription authorized by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner. **B. Is the Prescription Written for A Proper Purpose** 1\. To be valid a prescription must: a\. Be issued for a legitimate medical purposes b\. By an individual practitioner acting in usual course of professional practice 2\. Practitioner's Responsibility a\. The Practitioner is responsible for the proper prescribing and dispensing of controlled substances. 3\. Pharmacist's Responsibility a\. The Pharmacist has a corresponding responsibility to ensure proper purpose. b\. This Leads to a legal right to refuse to dispense if prescription appears issued in bad faith or for an improper purpose 4\. Penalties/Sanctions 1 Individual Practitioner -- a physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted to dispense a controlled substance in the course of professional practice, but does not include a pharmacist or a pharmacy. Dentist writes for Tylenol \#3 for a patient who injured his knee. MD writes for amphetamines to help a truck driver stay awake Chiropractors, psychologists, opticians cannot prescribe controlled substances.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 44 300759697v1 a\. An individual who knowingly dispenses an invalid prescription order, as well as the individual issuing it, can be subject to criminal and/or civil penalties and administrative sanctions. 5\. Office Stock or "Medical Bag Use" a\. A prescription may not be issued to allow an individual practitioner to obtain a supply of controlled substances for the purposes general dispensing to patients. Thus, a prescription written for office stock or "medical bag use" is not a valid request. b\. A pharmacy may however distribute controlled substances to an individual practitioner in the manner set forth above. 6\. A Prescription for Methadone Cannot Be Filled Unless It Is Issued For Analgesic Purposes a\. A prescription may not be issued for "detoxification treatment" or "maintenance treatment" unless the prescription is for a Schedule III, IV, or VI narcotic drug approved by the FDA. \(1) This does not preclude a medication typically used for detoxification or maintenance from being validly prescribed for pain. \(2) No Separate Registration is Required b\. A practitioner may administer or dispense -- but not prescribe -- a narcotic drug in any schedule to a narcotic dependent person for the purpose of maintenance or detoxification treatment if the practitioner is separately registered with the Attorney General to conduct a Narcotic Treatment Program. \(1) Exception: A physician need not separately register and may dispense or administer any controlled substance for detoxification or maintenance in an institutional setting via a medication order -- NOT A PRESCRIPTION: \(a) When arranging for addiction treatment a physician may dispense or administer a: one (1) day supply for a max of three (3) days -- \(b) When patient is admitted to institutional setting for a condition unrelated to the addiction, but to treat that condition the patient's addiction must be addressed through maintenance or detoxification treatment2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 45 300759697v1 \(c) When administering to a patient while hospitalized for a condition a physician may dispense methadone for reasons unrelated to the addiction. **C. Who May Fill a Prescription?** 1\. Only a pharmacist acting within the usual course of practice and licensed within the jurisdiction to dispense controlled substances pursuant to a prescription. 2\. Pennsylvania Requires the dispensing pharmacist initial and date the prescription. **D. What Information Must Be Present On The Prescription?** 1\. Date of Issue 2\. Prescriber's Signature - Where a Written Prescription is Required, Prescriber must manually sign the Prescription. 3\. Full Name & Address of Patient 4\. Drug Name, Strength, Dosage Form 5\. Quantity 6\. Directions for Use 7\. Name & Address of Prescriber 8\. DEA Number of Prescriber a\. An individual practitioner exempt from registration, discussed above, shall include on all controlled substance prescriptions the DEA registration number of the hospital or institution and the special internal code number assigned to the prescriber. **E. What If Information is Missing From the Prescription?** 1\. It is legal for the pharmacist to insert or correct the following items on the controlled drug prescription without obtaining a new prescription, upon consultation with the prescriber a\. Dosage form b\. Drug Strength c\. Drug quantity If the patient is an animal, the name and address of the owner and species of the animal is required.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 46 300759697v1 d\. Directions for Use e\. Issue date f\. DEA Number 2\. A Pharmacist may not change or insert: a\. The Patient's Name b\. Prescriber's Signature c\. Controlled Substance Prescribed -- Except for Generic Substitution. **F. CII Prescriptions** 1\. General Requirements a\. Written Prescription Required Unless Specific Exception Discussed Below Applies. b\. Signed by a Prescriber -- No Signature Stamps c\. The Pennsylvania e-prescribing law **mandates that all Schedule II** **through V controlled substances**, except were exempt or when dispensed or administered directly to a patient by a practitioner or authorized agent, other than a pharmacist, to an ultimate user, **shall be** **prescribed electronically**. In Pennsylvania, this law replaces the traditional method of prescribing controlled substances to a patient, i.e. paper prescription pads. 2\. Exceptions to a Written Prescription a\. When Can A Fax Replace The Need For A Written Prescription? \(1) A prescriber MAY fax the Schedule II prescription order to a pharmacy for an ordinary outpatient prescription, but the fax generally does not replace the need for a written prescription: \(a) The original written Schedule II prescription order must be presented to the pharmacist and verified against the facsimile at the time the controlled substance is actually dispensed. \(b) The pharmacist must make sure the original document is properly annotated and filed with the records that are required to be kept. No limit on quantity. No expiration date on a CII. PA NOW SAYS SIX MONTHS2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 47 300759697v1 \(2) Only under the following circumstances may a fax replace the need for a written prescription: \(a) A patient receiving direct administration by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion. \(b) A patient in a long term care facility (LTCF) \(c) A patient in hospice care as certified by Medicare under Title XVIII b\. An Electronic Prescription May Replace A Written Prescription \(1) A pharmacist may accept an electronically transmitted controlled substance prescription (CII-CV) from an authorized licensed prescriber or an authorized designated agent which has been sent directly to a pharmacy of the patient's choice, provided that the prescription contains all required information, and meets the following requirements: \(2) Certification: \(a) The provider of the application (e.g. a computer program) to be used by a pharmacy or practitioner must either hire a qualified third party to audit the application or have the application reviewed and certified by an approved certification body. \(3) Identity Proofing: \(a) Identity proofing is required in order to utilize electronic prescribing of controlled substances. \(b) Authorization to prescribe will not be granted to a practitioner until their identity has been confirmed. \(c) For two-factor authorization, DEA will permit the use of two of the following: i\) Something you know (a knowledge factor) ii\) Something you have (a hard token stored separately from the computer being accessed); and iii\) Something you are (biometric information).2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 48 300759697v1 \(4) Prescription Copies \(a) A practitioner may print copies of any electronic prescriptions for controlled substances if they are clearly labeled: "Copy Only -- not valid for dispensing." \(5) Multiple Patients And Prescriptions \(a) A practitioner is not permitted to issue prescriptions for multiple patients with a single signature. \(b) However, a practitioner is allowed to sign multiple prescriptions for a single patient at one time. \(6) Transmission Failure \(a) If transmission of an electronic prescription fails, the electronic prescription may not be converted by an intermediary to another form (e.g. facsimile) for transmission. \(7) Prescription Alterations \(a) An electronic prescription may not be altered as it is transmitted from a practitioner to a pharmacy. \(b) This does not apply to changes that occur after receipt at the pharmacy. \(c) Changes made by the pharmacy are governed by the same laws and regulations that apply to paper prescriptions. \(8) Prescription Back-Up \(a) Pharmacy application service providers must back-up files daily. \(b) Once a prescription is created electronically, all records of the prescription must be retained electronically. \(c) As is the case with paper prescription records, electronic controlled substance prescription records must be kept for a minimum period of two years. \(9) Duplicate Prescriptions2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 49 300759697v1 \(a) If pharmacist receives a paper or oral prescription that was originally transmitted electronically to the pharmacy, the pharmacist must check the pharmacy records to ensure that the electronic version was not received and the prescription dispensed. c\. A Written Prescription Is Temporarily Not Required In Emergency Situations \(1) Emergency Defined \(a) The immediate administration of the drug is necessary for proper treatment of the intended ultimate user; \(b) That no alternative treatment is available; and \(c) It is not possible for the prescribing practitioner to provide a written prescription order for the drug at that time. \(2) Dispensing Requirements \(a) The quantity must be limited to the amount needed to treat the patient during the emergency period. \(b) The order must be immediately reduced to writing by the pharmacist and contain of the information required for such a prescription discussed above. \(c) Pharmacist must make a reasonable effort to determine that the telephone authorization came from a valid practitioner. \(d) Within seven days after authorizing an emergency telephone prescription, the prescribing practitioner must furnish the pharmacist a written, signed prescription order. i\) If Practitioner fails to provide hardcopy -- Pharmacist must notify DEA. ii\) Must write on the face of the prescription -- "Authorization For Emergency Dispensing" iii\) Prescription must be dated to the original call in date. Pennsylvania Requires Written Prescription within 72 hours.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 50 300759697v1 iv\) The Pharmacist must attach the written prescription to the oral emergency prescription. \(3) A Central Fill Pharmacy cannot accept oral authorization for Emergency CII's. 3\. Refills are not permitted a\. An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total up to a 90-day supply of a Schedule II controlled substance \(1) The practitioner must provide written instruction on each prescription indicating the earliest date on which a pharmacy may fill each prescription, excluding the first prescription if the it is intended to be filled immediately. 4\. Partial Filling of a Schedule II Prescription a\. Partial filling of Schedule II prescription is permitted if it is being done on the request of the patient, or the practitioner who wrote the prescription; and the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. \(1) The remaining portions of a partially filled prescription for a Schedule II controlled substance may be filled but it shall not be filled later than 30 days after the date on which the prescription is written (issue date). \(2) For more background See the Comprehensive Addiction and Recovery Act of 2016 (CARA) b\. Partial filling of a Schedule II is permitted if the pharmacist is unable to supply the full quantity prescribed (e.g. because he/she is out of stock). \(1) Mark number dispensed; quantity remaining; date of partial fill; and pharmacist's initials \(2) Must complete the fill within 72 hours \(a) If CII cannot be supplied within 72 hours: i\) Prescriber must be notified; ii\) Must mark the prescription Void; and2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 51 300759697v1 iii\) Remaining amount cannot be supplied. c\. Partially filling of a Schedule II is permitted for LTCF Patient or Terminally Ill \(1) Mark Prescription with LTCF or Terminally Ill Patient \(2) Mark number dispensed; date of partial fill; and pharmacist's initials \(3) Prescription orders are valid for a maximum of sixty days from the date of issue \(4) Prescription must be marked "LTCF Patient" or "Terminally Ill" **G. CIII-V Prescriptions** 1\. Requirements a\. Prescription may be communicated orally, in writing, by facsimile, or by electronic prescription b\. If called in, order must be promptly reduced to writing (Fax or e-script may serve as hard copy) 2\. Refills a\. Maximum of 5 refills within 6 months from the date of issue b\. Refill Information must appear on back of prescription or in computer c\. Additional refills may be added by oral authorization to the original prescription provided that: \(1) Total quantity authorized, including the amount of the original prescription, does not exceed five refills or six months from the date of issue; \(2) The pharmacist records the additional refills on the back of the original prescription and initials and dates the prescription; \(3) The quantity of each additional refill is equal to or less than the quantity authorized for the initial filling of the original prescription. d\. After five renewals or after six months, whichever occurs first, a new prescription order is required.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 52 300759697v1 3\. Partial Filling a\. Must note the quantity dispensed and initials on the back of the prescription or in the computer b\. The totally quantity dispensed in all partial fillings may not exceed the total quantity prescribed c\. The dispensing of all renewals must still be within six-months. d\. It is permissible to dispense a prescription for a quantity less than the face amount prescribed, resulting in the actual number of renewals dispensed being greater than the number of renewals authorized on the prescription order. 4\. Transfer Between Pharmacies of Schedule III-V Prescriptions For Refill Purposes a\. Allowed on a One time basis \(1) Prescription Information may be transferred between pharmacies on a one time basis, unless: \(2) State Law Prohibits Transfers; or b\. Pharmacies sharing a real-time, online database may transfer up to the maximum refills allowed by law. c\. The DEA requires that the original prescription must be filled prior to any transfer. So a pharmacy may not transfer an unfilled prescription that it has on file to another pharmacy until it has been filled at least once. d\. Requirements \(1) Transfer must communicated directly between licensed pharmacists \(2) The Transferring Pharmacy's Records must reflect: \(a) The word "VOID" must appear on the face of the invalidated transferred prescription; \(b) Name, address, and DEA number of the Receiving Pharmacy; \(c) Name of Receiving Pharmacist, \(d) Date of Transfer;2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 53 300759697v1 \(e) Name of Transferring Pharmacist. \(3) The Receiving (Transferree) Pharmacy's Records must reflect: \(a) The word "TRANSFER" on the face of the transferred prescription; \(b) All information required for a Controlled Substance Prescription; \(c) Date of issue of the original prescription; \(d) Number of valid refills; \(e) Original date of dispensing; \(f) Name, address, DEA number, and prescription number of the Transferring Pharmacy; \(g) Name of the Transferring Pharmacist; and \(h) Name of the Receiving Pharmacist \(i) Dates and Locations of the previous refills if real-time, on-line electronic database used. **H. Administering or Dispensing Without Prescription** 1\. Individual Practitioner a\. For immediate administration -- i.e. Single dose administered to patient leaving the emergency room or during outpatient procedure. 2\. Institutional Practitioner a\. The immediate administration encompasses the hospital distribution system whereby drugs are administered from the hospital nursing station for a particular patient. 3\. A controlled substance listed in Schedules II-V which is not a prescription drug as determined under the FDCA may be dispensed by a pharmacist without a prescription provided that: a\. Such dispensing is made only by a pharmacist and not an employee of the pharmacist. b\. Limitations \(1) Amount2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 54 300759697v1 \(a) Opium -- No more than 8oz.(240cc) or 48 units \(b) Non-Opium -- No more than 4oz.(120cc) or 24 units \(2) Time -- No less than 48 hours between sales c\. Identity of Purchaser \(1) Must 18 years of age or older \(2) Must be known or suitably identified by Pharmacist d\. Bound Record Book must be maintained for dispensing and contain: \(1) Name and address of Purchaser; \(2) Name and Quantity of Drug Sold; \(3) Date of Sale; \(4) Name or Initials of dispensing Pharmacist. e\. Prescription must not be required under Federal, State or Local law \(1) Pennsylvania requires a prescription for All CV cough preparations which may not need a prescription under federal law. **VII. Labeling Requirements for Controlled Drugs** **A. Commercial Containers** 1\. The symbol designating the schedule (e.g. CII or C-II) must be prominently located on the label. a\. The word "Schedule" need not be used. b\. The symbol must be clear and large enough to be seen without removal from the dispenser's shelf. 2\. Exceptions a\. Not required on a carton or wrapper in which a commercial container is held if the symbol is legible through such carton or wrapper. b\. Not required if the commercial container is too small. c\. Not required if commercial container is used in clinical research involving blind or double-blind studies. Book must be maintained for two years.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 55 300759697v1 d\. Not required if the drug is intended for export. There is no exception for imports. 3\. Sealing Requirement a\. Every commercial container must be sealed in such a way to disclose tampering or opening of the container **B. Prescription Containers** 1\. The controlled substance label must contain: a\. Name and address of the pharmacy; b\. Patient's name; c\. Prescription number; d\. Name of the prescriber; and e\. Directions for use; f\. Cautionary Statements, if any. 2\. Additional requirements exist in PA: a\. The phone number and DEA number of the pharmacy; b\. Date of initial dispensing; c\. The trade or brand name of the drug, strength, dosage from and quantity dispensed; and d\. If generic is dispensed, then the manufacturer's name must also be shown. 3\. Transfer Warning a\. "Caution: Federal Law prohibits transfer of this drug to any person other than the patient for whom it is prescribed." b\. Federal Law requires Transfer Warning to appear on all prescription labels for Schedule CII-CIV. c\. PA Law requires it on CII-CV. 4\. Labeling requirements are waived for Institutional Settings2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 56 300759697v1 a\. If the ultimate user does not possess the drug prior to administration; and b\. If no more than a 7 day supply of a CII is dispensed; or c\. If no more than a 34-day supply or 100 unit doses of a CIII-V is dispensed. **VIII. Record Keeping Requirements** **A. A registrant must maintain the following records:** 1\. Official order forms (DEA Form 222). 2\. Power of Attorney authorization to sign order forms. 3\. Receipts and invoices for Schedule III, IV, and V controlled substances. 4\. All inventory records of controlled substances, including the initial and biennial inventories. 5\. Records of controlled substances distributed or dispensed (i.e., prescriptions). 6\. Report of Theft or Loss (DEA Form 106). 7\. Inventory of Drugs Surrendered for Disposal (DEA Form 41). 8\. Records of transfers of controlled substances between pharmacies. 9\. DEA registration certificate. **B. All records must be kept:** 1\. Readily available for inspection and for copying. 2\. Available For two years. **C. Types of Records** 1\. Inventory Records a\. General \(1) Inventory means a complete and accurate list of all stocks and forms of controlled substances in the possession of the registrant as determined by an actual physical count. \(2) Inventory includes all controlled substances "on-hand" on the date of inventory, including those:2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 57 300759697v1 \(a) Returned by patients; \(b) Ordered for patient but not yet invoiced; \(c) Stored in warehouse on behalf of registrant; \(d) Waiting to be picked up by patient; \(e) Expired and marked for return. \(3) All inventories for Schedule II controlled substances must be kept separate from those for all other controlled substances. \(4) All inventories for controlled substances must be readily retrievable. \(5) The DEA does not require that a copy of the inventories be submitted to it. b\. Initial Inventory \(1) Before a pharmacy commences business, a registrant must inventory all controlled substances in possession -- Even if there is no stock on hand. c\. Biennial Inventory \(1) Registrant is required to conduct an inventory every two years. \(2) CII -- Actual Physical Count Required to determine exact amount. \(3) CIII-V -- An Estimated Count is allowed, unless the container holds more than 1,000 dosage units and has been opened -- in this case an actual count is required to determine exact amount. d\. New Drugs \(1) When drug is added to schedule or moved to different schedule, the drug must be inventoried as of the effective date of scheduling. e\. Format \(1) The Inventory Record must include the following: \(a) Inventory date2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 58 300759697v1 \(b) Time the inventory is taken \(c) Drug Name \(d) Drug Strength \(e) Drug Form \(f) The Number of Units/Volume (i.e. 2x100 count bottle) \(g) The Total Quantity \(2) The DEA recommends the Inventory Record includes: \(a) Name, address, and DEA number of the registrant \(b) Signature of person responsible for taking inventory 2\. Purchase and Receipt Records a\. CI-II Ordering \(1) All orders for Schedule I and II controlled substances must be made on DEA Form-222. \(2) Copies 1 and 2 of the triplicate form must be sent to the distributor and must remain attached with the carbon intact. The purchaser keeps the third copy. \(3) Registrant's information should be preprinted on the form. \(4) Form must be signed by the registrant or by someone who has been given the power of attorney to execute the form. \(5) No alterations are allowed, including erasures or white-outs. If a mistake is made, all three copies of the form must be marked "VOID" and kept stored with all other executed forms. Do not throw them away. \(6) A partial filling of the order is permitted provided that the supplier sends the balance within 60 days. b\. CI-CII Receiving \(1) Must record the number of containers and date received. \(2) Only way to cancel part or all of order is to notify the supplier in writing or by fax. The supplier will mark items "cancelled", not the pharmacy.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 59 300759697v1 c\. CIII-CV \(1) Ordered like a non-control \(2) Upon receipt record the following: \(a) Date Received \(b) Number of Containers 3\. Dispensing Records a\. Available Filing Methods \(1) Three Separate Files \(a) CII \(b) CIII-V \(c) Non-Controlled Substances \(2) Two Separate Files \(a) CII \(b) CIII-V & Non-Controlled Substances b\. CIII-V must be readily retrievable if not filled separately, which means: \(1) The lower right corner of the face of the prescription must be stamped in red ink with the letter "C" no less than one inch high. Unless records are retrievable electronically. c\. Refills \(1) CII -- No Refills Allowed \(2) CIII-V -- Retrieval and Storage of Refill information may be accomplished two ways: \(a) Manual System i\) The Back of the Prescription must reflect for each refill the: (1) pharmacist's Initials; (2) quantity dispensed; and (3) date of each refill2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 60 300759697v1 \(b) Computer (ADP) System, if provides the following: i\) Online Retrieval of Original Prescription information for those orders, which are currently authorized for renewal. The information must include: \(1) Prescription Number \(2) Name and Address of Patient \(3) Date of Issuance \(4) Name, Strength, Dosage Form, and Quantity Prescribed and Dispensed. \(5) Total Number of Refills Authorized \(6) Initials or Name of the Dispensing Pharmacist \(7) Name, address, and DEA Number of the Prescribing Physician ii\) Online Retrieval of current renewal history information for those orders. The information must include: \(1) Name of the Controlled Substance \(2) Date of Renewal \(3) Quantity Dispensed \(4) Pharmacist's Initials \(5) Total number of renewals dispensed to date 4\. Disposal Records a\. Returns/Outdated Drugs -- See Section V, supra. b\. Theft -- See Section VI, supra. 5\. Alternative Records a\. Hospital Records2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 61 300759697v1 \(1) Purchase of CII's -- DEA Form 222 \(2) Purchase of CIII-V's -- Regular Purchase Order \(3) Outflow records are kept on patient charts by medication orders as opposed to prescription orders in a retail pharmacy. b\. Central Record Keeping \(1) Registrants must request approval from the DEA to store financial and shipping controlled substance records at a central location \(2) Unless the registrant receives notice of denied approval, the registrant may begin maintaining central records 14 days after notifying the DEA \(3) All records must be available for delivery within 2 days of a request from the DEA. \(4) Central Record Keeping Cannot store: \(a) Executed 222 Forms \(b) Prescriptions \(c) Inventory Records c\. Computerized Record Keeping -- A pharmacy's computer must: \(1) Provide On-line retrieval of original prescription information; \(2) Provide On-line retrieval of current refill history; \(3) Provide a refill-by-refill audit trail for any specific dosage form of a controlled substance by band name, generic name, or both. \(a) If the system provides a hard copy printout of each day's refills, the pharmacist must verify their accuracy by signing and dating the printout. \(b) The printout must include the following: i\) Prescribing Practitioner's name ii\) Patient's name and address iii\) Quantity dispensed on each renewal2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 62 300759697v1 iv\) Dispensing date for each renewal v\) Name of dispensing pharmacist vi\) Original prescription number \(c) In lieu of a printout, the pharmacy must maintain a bound logbook or separate file verified by the pharmacist. \(4) Include a backup procedure for refilling prescriptions during computer downtime. And it must ensure that renewals are authorized and the maximum number of renewals has not been exceeded. **IX. Mailing of Controlled Substances** 1\. U.S. Postal Service permits the mailing of any controlled substance. 2\. Requirements: a\. The outside wrapper or container must be free of markings indicating the nature of the contents; b\. The inside container must be marked and sealed in accordance the CSA; and c\. The inside container must be labeled to show the name and address of the pharmacy, practitioner, or other person dispensing the prescription order. **X. DEA Order Forms** **A. Obtaining Order Forms** 1\. Initially obtained by contacting any Division Officer or the Registration Section of the Administration 2\. After initial order, obtained by using DEA-Form 222a **B. Lost or Stolen Order Forms** 1\. If a completed DEA-Form 222 is lost or stolen on the way to the distributor, purchaser must: a\. Prepare a statement containing the following: \(1) The Serial Number on the form2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 63 300759697v1 \(2) The date of the initial order; and \(3) A verification that the drugs were not received. b\. The statement must be sent to the DEA. 2\. If a Blank DEA-Form 222 is lost; purchaser must: a\. Immediately report to the DEA; and b\. Provide Serial numbers for the forms lost. **C. Preservation of DEA Forms 222** 1\. Purchaser must retain Copy 3 of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached. 2\. The Supplier must retain Copy 1 of each DEA Form that it has filled. **XI. Detecting Violations of the Controlled Substances Act** **A. Valid DEA Numbers** 1\. Nine Characters a\. Typically, two letters \(1) 1st letter A or B, unless \(a) Mid-Level Practitioners = M \(b) Distributors = P or R \(2) 2nd letter or number is usually the first letter or number of the registrant's last name or name of business b\. Seven numbers 2\. Which DEA Number is Valid? AJ-0123456 or AJ-1234563 3\. The Method a\. Add the 2nd, 4th, and 6th numbers = subtotal 1; b\. Double subtotal 1 = subtotal 2; c\. Add the 1st, 3rd, and 5th numbers = subtotal 3;2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 64 300759697v1 d\. Add subtotals 2 and 3 together = subtotal 4; e\. If the last digit of subtotal 4 matches the last digit of the DEA number the number is valid. 4\. Examples a\. AJ-0123456 \(1) 0**1**2**3**4**5**6 \-- 1+3+5 = 9 \(2) 2 x 9 = 18 \(3) **0**1**2**3**4**56 = 6 \(4) 18 + 6 = 24 \(5) 2**4** ≠ 012345**6** \(6) AJ-0123456 is **INVALID** b\. AJ-1234563 \(1) 2+4+6 = 12 \(2) 2 x 12 = 24 \(3) 1+3+5 = 9 \(4) 24+9 = 33 \(5) 3**3** = 123456**3** \(6) AJ-1234563 is **VALID** **B. DEA Inspections** 1\. DEA inspections are made pursuant to the following: a\. Voluntary Consent and Notice of Inspection \(1) The person in charge of controlled premises has a constitutional right to refuse consent or withdrawal consent and to insist that the DEA obtain and Administrative Inspection Warrant b\. An Administrative Inspection Warrant \(1) Entry must be permitted2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 65 300759697v1 \(2) Probable Cause is required 2\. The DEA inspector must: a\. Show his credentials; b\. State his purpose; and either \(1) Present a Notice of Inspection or \(2) Announce that he has an Administrative Inspection Warrant **XII. New Technology Under the Controlled Substances Act** **A. Internet Pharmacies** 1\. Prescription must be valid a\. Controlled substance prescriptions may be filled by internet pharmacies as long as the prescriptions are valid and all CSA requirements are met. b\. As a practical matter, C-II prescriptions are rarely filled this way because the patient needs to present the original signed prescription prior to pickup. 2\. Corresponding Responsibility a\. As always, the pharmacist must make a reasonable effort to ensure legitimacy of the prescription order. **B. Central Filling Pharmacies** 1\. Established by retail pharmacies in order to send prescriptions off site for filling. 2\. Cannot accept a controlled substance prescription directly from a patient or deliver a prescription directly to the patient. a\. Remember Central Fill Pharmacies cannot accept direct Emergency CII's order either. 3\. The retail pharmacy may transmit the controlled substance prescription two ways: a\. Fax any controlled substance (CII-V) prescription; or b\. Electronically transmit any controlled substance prescription. Any time one retail pharmacy receives a prescription order and a second retail pharmacy fills the order and sends it back to the first retail pharmacy, the second pharmacy engages in central dispensing.2024 COPYRIGHT ©2024 BY Robert A. Gallagher. 66 300759697v1 4\. The transmitting retail pharmacy must: a\. Record at the time of Transmission \(1) Name, Address, and DEA number of the central fill pharmacy; \(2) Name of the transmitting pharmacist; \(3) The Date of Transmission. b\. Write "Central Fill" pharmacy on the face of the prescription; and c\. Record at the time of Receipt \(1) The Date of Receipt; \(2) Method of Delivery; \(3) Name of employee accepting delivery. 5\. The Central Fill Pharmacy must: a\. Retain the fax or electronic record of the prescription sent; and b\. Record \(1) Name, Address, and DEA number of the transmitting pharmacy; \(2) The Date transmitted prescription received; \(3) Name of the filling Pharmacist; \(4) Date of filling; and \(5) Date and method of delivery to original pharmacy.