pharmacy law exam 1 Flashcards

Question

Civil Court Procedures:Statute of Limitations what does it limit

Answer 1

Limits the period of time in which a case can be filed

Answer 2

Summons: issued by the court notifying the defendant of the suit and commanding the defendant to file an answer Complaint: contains all material facts of the case and remedy requested Answer: admitting to or denying allegations Default judgment if answer not filed

Answer 3

A pretrial process in which each side must give the other all facts, evidence, and names of witnesses upon which it will rely Deposition: out-of-court testimony by a witness under oath

Answer 4

Voir dire examination: the questioning by each side of potential jurors The jury’s role is to determine questions of fact. The judge must determine questions of law.

Answer 5

Witnesses May be subject to subpoena, an order to appear in court Failure to appear may result in contempt of court. Expert witnesses Called when the factual subject matter is beyond the scope of jurors

Answer 6

Motion for summary judgment: one party attempts to convince the judge that the claims of the other side have no merit, even if correct. Motion for directed verdict: after the introduction of evidence, one party alleges that the other lacks sufficient evidence. Objections: attempt to restrict the introduction of evidence or testimony; might constitute issues of law for appeal After all evidence is presented, the judge instructs the jury as to the applicable law.

Answer 7

Judgment notwithstanding the verdict (NOV): the judge may rule contrary to the jury if the jury clearly reached the wrong verdict. A mistrial may be granted if a major error or violation of law or procedure occurred during the trial. Either party may appeal the final verdict based on an error of law. For an appeal, attorneys submit a “brief” to the court, citing the legal principles and precedent involved and why the lower court erred.

Answer 8

A defendant can be either indicted or arrested. Indictments are issued by a grand jury when it determines that enough evidence exists for an arrest and trial. If arrested, the judge must determine at a preliminary hearing if there is enough probable cause for an arrest; if so, the defendant must enter a plea at an arraignment. The parties may agree to a “plea bargain,” in which the defendant agrees to a lesser charge rather than face a trial. Burden of proof is “beyond a reasonable doubt,” rather than a “preponderance of the evidence” as in a civil trial.

Answer 9

State and federal appellate court decisions are often reported and have citations. From the citation, one can tell the names of the parties, which court decided the case, and the volume and page number where the case can be found.

Answer 10

Federal Regulation of Medications: Development, Production, and Marketing

Answer 11

Protection of the public against adulterated and misbranded drug products Necessity of balancing “direct regulation” and “indirect regulation”

Answer 12

Housed under the Department of Health and Human Services (DHHS) Authority for administering the FDCA FDA secretary appointed by president with confirmation of Senate

Answer 13

National headquarters and extensive field force Five offices under commissioner: Office of Foods and Veterinary Medicine Office of Global Regulatory Operations and Policy Office of Medical Products and Tobacco Office of Operations Office of Policy, Planning, Legislation and Analysis

Answer 14

Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Tobacco Products Oncology Center of Excellence Office of Special Medical Programs Patient Affairs Staff

Answer 15

Rulemaking Issue guidance documents Incorporate advice from standing advisory committees of outside experts

Answer 16

Articles recognized in the USP or homeopathic pharmacopeia Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease (Part B) Articles other than food intended to affect the structure or function of the body (Part C) The definition is intentionally broad to include almost anything with an intended therapeutic purpose or purpose of altering the structure or function of the body

Answer 17

Labeling Advertising Nature of product

Answer 18

Generally depends upon the intended use Food definition is not very helpful in itself Congress likely intended the meaning of food in the exclusion from part C of the drug definition to apply to food used for its ordinary purpose and in an ordinary manner.

Answer 19

Legal categories Special dietary foods Medical foods Publicly conceived categories Nutraceuticals and functional foods

Answer 20

A health claim for a food made by a manufacturer could result in the product being considered a drug. The Nutrition Labeling and Education Act of 1990 and subsequently FDAMA allow foods to contain health claims if approved by the FDA by regulation or by the “significant scientific agreement” test. Manufacturers must submit considerable evidence to support the claim to obtain FDA approval.

Answer 21

DSHEA Created a new special category of food called “dietary supplements” (DSs) DSs do not require premarket approval DS is defined as a vitamin, mineral, herb, or other botanical, amino acid, or substance used to supplement the diet by increasing total dietary intake

Answer 22

DSHEA permits four types of nutritional support claims: Benefiting a classical nutrient deficiency disease Describing the role of the DS in affecting the structure/function of the body Characterizing the mechanism by which a DS acts to maintain the structure or function Statements of general well-being Claims must be substantiated as truthful and not misleading. The label must contain a disclaimer.

Answer 23

DSHEA only permits DS manufacturers to make health claims if either the FDA approves the claim by regulation or by the significant scientific agreement test. Pearson v. Shalala, however, held that DS manufacturers could make health claims not approved by the FDA, provided they are not false or misleading and accompanied by a disclaimer. The FDA now allows qualified and unqualified health claims.

Answer 24

DSHEA excludes an article as a DS if it was approved as a drug prior to being marketed as a DS. The Pharmanex case establishes that DSs cannot be specially manufactured to concentrate the natural drug ingredient.

Answer 25

The FDA can only remove a DS on the basis of the product being adulterated, defined as presenting a “significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.” Example: ephedrine alkaloid DS The Dietary Supplement and Nonprescription Drug Consumer Protection Act requires manufacturers to report serious adverse events.

Answer 26

Product selection Education of patients as opposed to promotion of products Restrictions regarding the display of DS publications

Answer 27

The historical approach of the FDA prior to the Medical Device Amendments was to declare devices as drugs when necessary. The definition of a device excludes articles that achieve their purpose through chemical action and metabolism. Whether a device containing drugs is a drug or device is dependent on various factors.

Answer 28

The definition of cosmetic generally includes topical articles intended for cleansing, beautifying, or altering appearance. A cosmetic can become a drug if the seller makes a health or structure/function claim. “Ignorant, unthinking consumer” standard likely applied Some products can be both cosmetics and drugs.

Answer 29

The term labeling includes labels. Labeling is defined as written or printed or graphic matter “accompanying” the article. Courts have defined accompanying. If the written, printed, or graphic matter is not labeling, it is advertising.

Answer 30

USP Published by the USPC Sets uniform standards USPC works closely with the FDA, but is private. HPUS Publishes standards for homeopathy products by the HPCUS, a private organization Role and legal authority of HPUS Pursuant to FDCA, if a drug is recognized in USP or HPUS, the drug product must meet all standards of the compendia.

Answer 31

Most prohibited acts involve misbranding or adulteration. Violation of FDCA is subject to strict liability Good faith excuse applicable to pharmacies 1 - receipt and subsequent delivery of an adulterated or misbranded drug (Section 301(c)) 2 - The doing of any act which causes a drug to be counterfeit (Section 301(i)(3)) The alteration, mutilation, etc. of the labeling (Section 301(k))

Answer 32

Injunction Criminal action Seizure of products Warning letters

Answer 33

Affirmative duty of corporate officers to be aware of and correct violations

Answer 34

The FDA established the FDA authority to order drug recalls for certain products, but not drugs. Three classes of recalls Manufacturers are responsible for notifying sellers; sellers are responsible for notifying consumers, if necessary Pharmacists responsible for knowing of product recalls

Answer 35

Adulteration provisions focus on both the facility and the product. A pure drug may be considered adulterated on the basis of the facility. A drug is adulterated if its strength, quality, or purity differs from compendia standards unless plainly stated on the label. A drug is adulterated if its strength, quality, or purity differs from the label.

Answer 36

A product is adulterated unless manufacturer complies to CGMP. CGMP is an exhaustive set of standards directed at manufacturers. The failure to manufacture a product in a tamper-resistant container when required by law is adulteration and also misbranding.

Answer 37

Labeling must not be false or misleading, including healthcare economic information. Labeling must include a listing of active ingredients and quantity and a listing of inactive ingredients in alpha order. Labeling must contain “adequate directions for use” and “adequate warnings against use” by children and others for whom use might be dangerous. If a drug cannot be labeled with “adequate directions for use,” it must contain “adequate information for use.” It is misbranding if a drug imitates another drug.

Answer 38

User-friendly format including pharmacological category or principal intended use, cautions and warnings, adequate directions for use, and “Drug Facts” panel Pharmacies that relabel or repackage must conform to the same labeling requirements as manufacturers. Professional OTC labeling may be published by manufacturers for indications not appropriate for lay diagnosis or treatment. Drugs that are both OTC and prescription exist when some indications can be labeled with adequate directions for use and some cannot.

Answer 39

Regulations specify information requirements of commercial labels. Unit dose labeling is subject to different information requirements. Newer package insert requirements include a “Highlights” section at the beginning, a table of contents, “Full Prescribing Information” organized to give prominence to the most important information, and a “Patient Counseling Information” section.

Answer 40

Required in labeling when use of a drug may lead to death or serious injury Required for many prescription drugs

Answer 41

The labeling system prior to June 30, 2015, required that drugs potentially risky during pregnancy be placed into one of five categories: A, B, C, D, and X. A 2014 regulation replaces the above system. For drugs approved after June 30, 2015, labeling will require the inclusion of three subsections to describe risks: “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential.” Drugs approved prior to June 30, 2015, will be gradually phased into the new labeling standards.

Answer 42

10-digit three segment code (4-4-2, 5-3-2, or 5-4-1) The first segment identifies the manufacturer or distributor; the second identifies strength, dosage form, and formulation; and the third identifies package size and type of drug. Billings and claims submissions require an 11-digit NDC number.

Answer 43

No person may introduce a “new drug” into interstate commerce unless approved by the FDA. “New drug” is defined as a drug that is not generally recognized by qualified experts as safe and effective (GRASE) for use under the conditions recommended in the drug’s labeling and has been used for a material extent and time for conditions recommended in the labeling. The FDA will not accept a GRASE application and requires a new drug application.

Answer 44

An approved drug can become a new drug under certain conditions: Addition of new substance New combination of approved drugs Change in proportion of ingredients New intended use Dosage, method, or duration of administration or application is changed

Answer 45

IND Investigational New Drug Application The sponsor must receive approved Notice of Claimed Investigational Exemption for a New Drug in order to ship drug in interstate commerce to conduct phase 1, 2, and 3 clinical studies. The FDA may terminate testing at any time under risk–benefit criteria; the decision is not subject to appeal or judicial review. The FDAAA requires NDA sponsors to publish summary information regarding phase 1 trials on a public registry.

Answer 46

Informed consent required in all three phases Research subjects required to know risks, possible benefits, and alternative courses of treatment Institutional Review Board (IRB) approval required in some settings

Answer 47

The FDA has 180 days to act on a completed NDA, but delays are common. Approval is based on proof of safety and efficacy, the manufacturing process, and risk–benefit ratio. Applicant may judicially appeal a rejected NDA, but success is very unlikely.

Answer 48

Passed in 2016 Objectives include streamlining and adding flexibility to the drug development and approval process and creating a more patient-focused approach to the process. It encourages the consideration of novel clinical trial designs and the incorporation of “real-world evidence” into the decision-making process. The law also creates or amends four pathways or programs for drugs that treat serious or life-threatening diseases that affect smaller populations or diseases with significant public health risk

Answer 49

SNDA is generally required when a manufacturer makes any change in an approved drug or in its production Three categories of SNDA A “change being effected (CBE)” SNDA allows the sponsor to make the change before FDA approval and is important for labeling changes.

Answer 50

A priority classification system rates new drugs by chemical type and therapeutic potential this determines how quickly the drug will move through the IND/NDA process. A number designates chemical type, and a letter (S, P, or O) designates therapeutic potential.

Answer 51

Required of the manufacturer after NDA approval Must submit to FDA reports of serious adverse drug reactions and any new information on safety and efficacy

Answer 52

The FDAAA empowered the FDA to require manufacturers to conduct phase 4 studies when adverse event reporting or active surveillance is inadequate.

Answer 53

The FDAAA granted the FDA authority to require REMS as a condition for approval of an NDA or postmarket when the FDA believes it necessary to ensure benefits outweigh risks. Under REMS authority, the FDA can require a variety of procedures ranging from Medication Guides to limiting the drug to specified settings for dispensing.

Answer 54

The FDAAA gave the FDA the authority to require manufacturers to add safety information or warnings postmarket.

Answer 55

The FDAAA required the FDA to develop and maintain a website for patients and providers including labeling, safety information, REMS, guidance documents, etc. The FDAAA also established “Sentinel Initiative” designed to detect early signs of a drug's risk

Answer 56

Initiated to evaluate the efficacy of drugs approved between 1938 and 1962 The FDA created the ANDA for generic drugs approved between 1938 and 1962. The ANDA only requires evidence of bioequivalence and manufacturing methods rather than proof of safety and efficacy. The U.S. Supreme Court ruled that generic drugs are new drugs and subject to FDA approval.

Answer 57

The FDA lacked the authority to allow ANDAs for post-1962 generics, so it created the “paper NDA.” The paper NDA was not very effective.

Answer 58

Statutorily created the ANDA, expediting generic approval Concessions to innovator drug companies included: Patent extensions Market exclusivity

Answer 59

The generic manufacturer must make one of four types of patent certifications. A paragraph IV certification contends that the parent drug’s patent is invalid or will not be infringed by the generic company. The ANDA applicant must notify the patent holder. If the holder sues, the FDA is enjoined for 30 months, unless a court rules otherwise. The generic company receives 180 days of market exclusivity if it prevails under a paragraph IV certification.

Answer 60

Bioequivalence of generics to the parent and each other Whether a drug without market exclusivity for a particular indication could be prescribed and dispensed for that indication

Answer 61

Producing “authorized generics” 30-month stay from ANDA approval awarded when a patent holder sues for patent infringement Filing of secondary patents, often for product changes and attempts to shift market share to new product Exclusion payments (pay-for-delay agreements)

Answer 62

Whether FDA can approve an ANDA for a generic when the labeling will not include one or more of the indications contained on the innovator drug product’s labeling Whether generic drug manufacturers should be required to change labeling to reflect a known adverse effect

Answer 63

Similar to extinct “paper NDA” Used to file for: New indications for approved drugs Generic approvals that do not qualify under ANDA

Answer 64

The goal is to institute new policies aimed at bringing more competition to the drug market, most notably improving the efficiency of the generic drug approval process. Policies designed to bring complex generic drugs to market more quickly Guidance also released to streamline the ANDA process for all generic drugs

Answer 65

The OTC drug review process approves drugs on the basis of therapeutic category and conformance to a monograph rather than on a drug-by-drug basis like prescription drugs.

Answer 66

The FDA estimates that there are thousands of unapproved drugs on the market today. Reasons include: Pre-1938 drugs The FDA has yet to remove some drugs lacking efficacy after DESI. Lax FDA policies applied to generic approvals prior to 1984 Unscrupulous manufacturers If a manufacturer obtains NDA approval for an unapproved marketed drug, all marketed drugs in the class must obtain NDA approval within one year.

Answer 67

An investigational drug may be used for treatment outside of phase 1, 2, or 3 clinical tests. Only for patients with serious or life-threatening diseases for which no comparable or satisfactory alternative therapy is available Certain conditions must be met.

Answer 68

Individual patients acting through a physician may request an investigational drug for treatment purposes if the physician determines the patient has no comparable or satisfactory alternative and that the risk from the drug is no greater than the risk from the disease or condition. The FDA had restricted requests to drugs in phase 3 leading to the Abigail Alliance lawsuit. The Abigail Alliance decision rejected the plaintiffs’ claim that they have a constitutional right to investigational drugs.

Answer 69

The FDA enacted regulations permitting greater access by patients to investigational drugs. Permits patients to seek access to experimental drugs even in phase 1 Expands and clarifies the treatment use of experimental drugs Clarifies and establishes the criteria for drug manufacturers to charge patients for investigational drugs Several states have passed “right-to-try” laws

Answer 70

Expedited review is possible for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs for the condition and have an effect on a clinical endpoint predictive of clinical efficacy. Conditional on manufacturer agreeing to phase 4 testing “Accelerated approval” also available for certain drugs

Answer 71

Products derived from living organisms Licensure by PHSA, but subject to FDCA and FDA requirements The Biologics Price Competition and Innovation Act created a regulatory framework in 2010 for biosimilars or “follow-on” biologics. The FDA Purple Book lists biological products, including any biosimiliar and interchangeable biological products.

Answer 72

Voluntary reporting system to allow healthcare professionals to report any serious adverse events, product use errors, and product quality issues The FDA emphasizes the importance of reporting by healthcare professionals. The FDAAA requires pharmacies to provide patients with the MedWatch number and a statement about reporting side effects.

Answer 73

Establishes criteria for classifying devices into one of three classes The FDA has authority to reclassify devices based on new safety and efficacy information. Medical device manufacturers and device-user facilities must report any deaths or serious injuries related to their products. The FDA can require firms to notify healthcare professionals, repair or replace devices, or refund purchase price of devices. The FDA can recall devices.

Answer 74

No premarket approval, nor conformance with CGMP Manufacturers must substantiate product safety. The FDA may remove if misbranded, adulterated, or a health hazard. Must be labeled with list of ingredients in descending order of predominance and appropriated warnings

Answer 75

The FDA regulates Rx drug advertising, and FTC regulates OTC drug advertising. The First Amendment restricts government regulation of commercial advertising. Any regulation will be evaluated pursuant to the four factors established by the U.S. Supreme Court.

Answer 76

Section 502(n) requires all advertisements to contain “true statement” and “brief summary.” Reminder advertising is exempt. True statement is not met if advertising is false or misleading, does not present a fair balance, and fails to reveal material facts. Advertising includes ads in journals and other periodicals, broadcast media, and telephone communications. Brochures, booklets, mailings, bulletins, calendars, and other information distributed to healthcare professionals by a manufacturer is labeling.

Answer 77

Applicable to broadcast media The manufacturer only needs to include “major risks” as opposed to brief summary. The manufacturer must make adequate provisions for the dissemination of the labeling.

Answer 78

Journal advertising Actively scrutinized by FDA after early studies showed considerable violation Industry-supported educational programs Concerns that programs are independent and objective Factors distinguishing independent from promotional programs published in guidance document The court decision requires that the guidance document be used as a “safe harbor.” PhRMA has published self-policing guidelines.

Answer 79

Physician Payment Sunshine Act FDA Bad Ad Program

Answer 80

Significant congressional and public controversy No specific laws and regulations, thus Section 502(n) applies Because compliance with Section 502(n) is impractical, FDA allows manufacturers to apply the “adequate provision” requirement. The consumer must be offered full labeling information from one or all of four sources.

Answer 81

For DTC print advertising, FDA encourages manufacturers to present key risk information in user-friendly ways. Reminder and help-seeking ads are exempt from requirements. The GAO report noted FDA weaknesses in regulating DTC ads. The FDAAA has provided FDA with the authority to require prereview of ads.

Answer 82

FDA guidance documents relating standards for: Communications through interactive promotional media Communications through social media platforms with space limitations Correcting third-party misinformation through the internet or social media

Answer 83

Manufacturers providing off-label use information is very controversial; FDAMA allowed with restrictions The 2009 compliance guide reinstituted most of FDAMA off-label use provisions, clarified by 2014 compliance guide. The U.S. v. Caronia decision may limit FDA’s authority to regulate off-label use communications. Amarin Pharma, Inc. v. FDA ruled against the FDA to allow the company to engage in truthful and non-misleading “promotion” of off-label use information to healthcare professionals. Due to confusion, the FDA responded with two draft guidance documents in January 2017.

Answer 84

The FTC under the FTC Act regulates deceptive ads. Ads are deceptive when they are likely to mislead reasonable consumers; ad claims must have a reasonable basis. The FTC need only prove consumers are “likely” to be misled, not that they actually are misled. The FTC has authority to require corrective advertising.

Answer 85

Prohibits use of any false description or representation Allows for private cause of action and recovery of monetary damages

Answer 86

Establishes criteria for distinguishing prescription drugs from OTC drugs Legally establishes oral prescriptions and refills Although the amendment did not contemplate electronic prescriptions, other federal and state laws permit them.

Answer 87

Exempts the pharmacy label on dispensed drugs from Section 502, except for certain provisions Specifies the minimum information that a dispensed Rx label must contain Expiration or beyond-use dating on dispensed Rx labels is required pursuant to state laws

Answer 88

Three methods: SNDA: product-specific switch Petition: product-specific switch Adding or amending an OTC drug monograph: affects all products in the class

Answer 89

Refers to creating a class of drugs that can only be sold from the pharmacy department Rationale based on the fact that more dangerous drugs are being switched and would allow even more to be switched Historic opposition of the FDA appears to be shifting

Answer 90

Prescription refill authorization issues Distinguish authorization of refill from transmittal authority Prescriptive authority issues Federal law leaves it up to the states to determine who may prescribe independently or in collaborative practice. Scope of authority as determined by the state for prescribers who are not MDs or DOs is important for pharmacists to know.

Answer 91

Plan B approved in 1999 as Rx only Citizen Petition in 2001 requesting switch to OTC status without age restriction followed by SNDA requesting the same in 2003 After initial rejection of Barr’s SNDA, the FDA finally approved the drug in 2006 as OTC in women 18 and older and only sold behind the counter of pharmacies. FDA denied Citizen Petition in 2006 prompting Tummino lawsuit, where judge found FDA abused its discretion Judge ordered age reduced to 17 and FDA to reconsider petition

Answer 92

In 2011, Teva submitted SNDA for drug as OTC without age or point-of-sale restriction. FDA Commissioner approved SNDA to eliminate age restriction in 2011; overturned by secretary of DHHS The FDA again denied the Citizen Petition leading to another Tummino decision in 2013 where the court reversed the FDA’s decision and ordered the FDA to make Plan B OTC without restrictions. The FDA ultimately declined to appeal and approved Plan B One-Step as an OTC drug without restriction.

Answer 93

Refers to whether a pharmacist has a right to refuse to dispense prescriptions when a moral or religious objection exists States have passed laws or regulations addressing this issue. Courts have held that a pharmacist cannot obstruct a patient’s legal right to receive medications. State regulations requiring pharmacists to dispense except in certain situations have been upheld.

Answer 94

Collaborative practice agreements Authority granted to pharmacists in most states Authority to dispense Depends on state law The FDA does not believe D-H dispensing standards apply to prescribers; however, most states regulate prescriber dispensing in some manner.

Answer 95

Patient package inserts (PPIs) Although the FDA originally had wanted PPIs required for most drugs, it applies to very few, including estrogen-containing drugs, DES, and oral contraceptives. Duty of manufacturers and pharmacists to distribute to patients Law applies to institutional pharmacy as well as community.

Answer 96

Consumer medication information (CMI) Originally, the FDA wanted to require MedGuides for drugs posing a serious and significant concern to public health and CMI for all other drugs. Congress intervened to prevent the FDA from implementing CMI rules and allowed private sector to develop standards for CMI. A 2008 study shows private sector has not yet met the 95% “useful information” standard required by Congress. Responsibility of manufacturer and dispenser to dispense MedGuides to patients for drugs requiring MedGuides

Answer 97

Medication guides (MedGuides) Required for drugs FDA has determined as posing “serious and significant concerns” Required for new and refill prescriptions Generally required for outpatients not under direct supervision of healthcare professional with some exceptions Content of MedGuide must be approved by FDA Every new MedGuide approved since 2007 has been in conjunction with a REMS. FDA proposing a single page information document

Answer 98

Drug products commonly prescribed for off-label uses Off-label prescribing and dispensing is legal under FDCA. Off-label prescribing and dispensing require a professional evaluation of risk vs. benefit. Courts generally regard labeling as evidence toward the standard of care and not as prima facie establishing the standard of care.

Answer 99

Pharmacies compounding for their patients pursuant to prescription are exempt from FDCA manufacturing provisions. FDA 1992 compliance guide Published by FDA over concern that some pharmacies were crossing the line from compounding to manufacturing and were not compounding properly FDAMA (Section 503A) 1997 Defined compounding and delineated nine activities that might cross the line from compounding to manufacturing; added other requirements regarding compounding Stripped FDA of authority to consider compounded drugs as “new drugs”

Answer 100

The U.S. Supreme Court ruled that advertising restrictions in Section 503A were unconstitutional, but failed to consider if all of the compounding law was invalid as ruled by the Ninth Circuit or whether the unconstitutional provisions were severable. FDA 2002 compliance guide The FDA adopted the Ninth Circuit’s position that Section 503A was not valid, but reinstituted most of its requirements in the 2002 compliance guide. Reestablished position that pharmacy-compounded drugs are new drugs

Answer 101

The Fifth Circuit disagreed with the Ninth Circuit and found that the unconstitutional advertising provisions of Section 503A are severable. It further found that compounded drugs are thus exempt from the new drug provisions, provided the pharmacy meets all the conditions established in Section 503A. Franck’s Lab decision regarding compounding for animals

Answer 102

Passed as part of Drug Quality and Security Act in response to New England Compounding Center tragedy Reinstated Section 503A, minus unconstitutional provisions, thus stripped FDA of its perceived new drug authority It allows compounders of sterile products to voluntarily register as “outsourcing facilities”- 503 B Products are exempt from misbranding provisions but must meet certain CGMP requirements.

Answer 103

Outsourcing facilities: May compound non-sterile drugs May dispense to individual patients Cannot have a separate area functioning as a Section 503A pharmacy

Answer 104

The NECC event and DQSA prompted many states to enhance compounding laws and regulations. Many state laws and regulations follow USP standards.

Answer 105

Section 503A and Section 503B do not exempt repackaged drugs from the act. Compliance guidance, however, provides conditions under which the FDA will not take enforcement action.

Answer 106

Compounding “regularly or in inordinate amounts” products that are “essentially copies” of “commercially available products” prohibited unless change for an identified patient produces a significant difference Guidance provides definitions of terms for Section 503A pharmacy and Section 503B outsourcing facility.

Answer 107

The FDCA does not permit this under Section 503A or Section 503B. Compliance guidance, however, provides conditions under which the FDA will not take enforcement action.

Answer 108

Unless an outsourcing facility must comply with Section 503A Compliance guidance, however, permits hospital pharmacy to compound without receiving prescriptions or orders, provided certain conditions are met.

Answer 109

Both Sections 503A and 503B facilities subject to Section 501(a)(2)(A) adulteration provisions Compliance guidance describes insanitary conditions, procedures and actions facilities should employ, and potential regulatory actions.

Answer 110

Section 503A requires that bulk drug substances used in compounding must appear on a list as developed by the FDA pursuant to regulation. Section 503B requires that bulk drug substances used in compounding must appear on a list established by the FDA based upon clinical need or an FDA list of drug shortages.

Answer 111

Compounding of radiopharmaceuticals specifically excluded from the exemptions of Section 503A The guidance document, however, provides conditions under which the FDA will not take action when nuclear pharmacies compound or repackage to meet patient needs. Section 503B applies to the compounding of radiopharmaceuticals.

Answer 112

MOU required between state and FDA in order to allow a compounder to distribute more than 5% of total prescriptions dispensed or distributed Draft MOU guidance requires states to determine if compounder’s interstate distributions are “inordinate” and defines “inordinate.”

Answer 113

Guidance prohibits supplying compounded drugs for “office use;” the drug product is compounded must be for an identified individual patient based on the receipt of a valid prescription order. The guidance interprets “limited quantity” as applied to anticipatory compounding.

Answer 114

Dietary supplements OTC drugs Manufacturer patent issues

Answer 115

Establishes standards for all healthcare entities that handle hazardous drugs (HDs) Compliance required by December 1, 2019 HDs are defined and identified by the National Institute for Occupational Safety and Health (NIOSH); the Institute maintains a list of these drugs (to be updated in 2018). Allows entities to make an assessment of risk and to determine alternative strategies

Answer 116

State generic substitution laws Every state permits pharmacists to substitute generically in some manner. State laws differ considerably. Labeling must accurately differentiate generic product from brand.

Answer 117

Evaluates pharmaceutically equivalent products on the basis of bioequivalence Pharmaceutical equivalence—products contain same active ingredients and are identical in strength and dosage form Bioequivalent pharmaceutical equivalents are generally presumed therapeutically equivalent—having the same clinical safety and efficacy. The Orange Book uses a two-letter rating system; some products use two letters and a number. Pharmacists must comply with state law when substituting and exercise professional judgment substituting B-rated products.

Answer 118

Drugs with less than a two-fold difference between median lethal dose and median effective dose or two-fold difference between minimum toxic concentrations and minimum effective concentrations Controversy exists as to whether the FDA’s statistical parameters for bioequivalence are accurate enough for certain NTI drugs; the FDA drafted new guidelines. Pharmacists should exercise particular professional judgment when called upon to substitute B-rated NTI drugs.

Answer 119

Under the BPCIA, to be “interchangeable” a biosimilar must not only be “highly similar” but also produce the same clinical result as the reference product without greater risk. The Purple Book provides a guide to health care professionals. Interchangeable biosimilars may be substituted without intervention of a prescriber (state law allowing).

Answer 120

Numerous opportunities for diversion and introduction of counterfeit drug products Federal efforts to protect the security of the drug supply chain include the Prescription Drug Marketing Act of 1987 and the Drug Supply Chain Security Act of 2013.

Answer 121

Requires state licensing of wholesalers Bans reimportation of Rx drugs except by manufacturer Bans sale, trade, or purchase of Rx drug samples Mandates requirements for Rx drug samples Prohibits resale of Rx drugs purchased by hospitals or healthcare facilities

Answer 122

Drug samples Establishes restrictions to limit misbranding and adulteration situations Defined as a unit of drug not intended to be sold and intended to promote the sale of the drug Establishes requirements for distribution to prescribers Prohibits community pharmacies from receiving samples

Answer 123

Purchase and resale Enacted to prevent hospitals and similar entities from reselling, purchasing, trading, or offering to do any of these activities; differentially priced drugs to community pharmacies and others so as to prevent adulteration and misbranding opportunities Important exceptions exist, most notably selling or dispensing Rx drugs pursuant to prescription.

Answer 124

Product returns permitted Wholesaler regulation intensified

Answer 125

The FDA granted authority to require secondary wholesalers to maintain pedigrees of drugs. The 1999 regulation to implement was enjoined on the grounds it would likely cause irreparable harm to secondary wholesalers and violate the equal protection clause. The FDAAA in 2007 mandated that the FDA develop track and trace standards and SNIs, but fell short of developing a true federal pedigree program until the DSCSA of 2013.

Answer 126

Established timeline for trading partners toward implementation of a track and trace system A full system electronic track and trace system must be in place by November 2023. Applies to transactions where prescription drugs change ownership with some important exceptions Establishes uniform national licensing standards for wholesalers and 3PL providers

Answer 127

Trading partners include: Manufacturers Wholesalers Repackagers 3PLs Pharmacies

Answer 128

Trading partners must have a system to quarantine, investigate, and notify the FDA and other partners of “suspect” and “illegitimate” prescription drug products.

Answer 129

Includes transaction information, history, and statement Must be passed, received, and maintained for six years by each trading partner Any method (paper or electronic) of passing the information is permissible until November 2023, at which time only electronic is permissible. Important exceptions for pharmacies

Answer 130

Manufacturers are required to affix UPI to each individual package and homogenous case by November 2018.

Answer 131

PDMA generally prohibits reimportation of Rx drugs Many stakeholders wish to obtain Rx drugs from Canada and other countries because of lower costs. The FDA has instituted a “compassionate use policy.” The CSA also allows for limited personal importation. The MMA allows wholesale importation of Rx medications from Canada, provided the secretary of DHHS would approve. The Homeland Security Act permits limited personal importation from Canada. The FDA will enforce the no importation law against businesses (Rx Depot case).

Answer 132

The FDA can inspect a pharmacy to determine if the pharmacy is compounding or manufacturing. It can extend the search if probable cause exists that the pharmacy is manufacturing. The FDA may search without a warrant.

Answer 133

Tax-paid alcohol Used in compounding in community pharmacies Obtainable from outlets that sell liquor at retail Tax-free alcohol (190 proof ethyl alcohol) Available to hospitals for medicinal, mechanical, and scientific purposes and in treatment of patients. May be used only for inpatients. Charity clinics may use for medicines for outpatients if they do not charge.

Answer 134

Intent of act to protect children from accidental poisonings due to “household substances” Administered by the Consumer Product Safety Commission The law establishes the standards for child-resistant containers. Container may not be reused unless glass or threaded plastic and then only with new closure.

Answer 135

Exemptions Prescriber requests- only good for that prescription Patient requests- good for all the drugs that the patient requests for, does not have to be in writing Institutionalized patients Certain drug products such as SL nitroglycerin and SL and chewable isosorbide dinitrate For manufacturer: may market one size in noncompliant package with appropriate statement

Answer 136

Price advertising Considered reminder advertising and thus exempt from Section 502(n), provided that certain conditions are met Product advertising Subject to strict liability standard

Answer 137

Challenges to state laws that prevented advertising based on the reasonableness of the laws had failed The Virginia decision established that the First Amendment applies to commercial speech and to recipients of the speech. The Virginia decision does not bar states from prohibiting false or misleading advertising, advertising professional superiority, or making it illegal for pharmacies to offer discounts or rebates.

Answer 138

Creates a closed system via registration Establishes national uniformity Enforced by DEA

Answer 139

State law must be stricter than federal law to not conflict. Pharmacists should follow stricter law. The DEA generally has a close relationship with state pharmacy boards. Presumption of interstate commerce in the federal regulation of controlled substances

Answer 140

Narcotic: natural or synthetic opium or opiates or derivatives including cocaine, which is not an opiate derivative

Answer 141

Placement into one of five schedules depending on abuse potential and degree to which drug may cause physical or psychological dependence

Answer 142

No accepted medical use, as opposed to drugs in the other schedules High potential for abuse and lack accepted information on safety of use Includes hallucinogenics, some opiates, methaqualone, and unapproved GHB

Answer 143

Marijuana for medical purposes: legal in many states and in a few states for recreational use, as well Marijuana remains a C-I drug under federal law. Federal courts have held that there is no constitutional right of patients to obtain marijuana. The U.S. Supreme Court held that federal agents can seize medical marijuana because of a presumption of interstate commerce. The U.S. Supreme Court held that marijuana buying cooperatives violate the CSA. Federal court held that government could not take action against physicians who recommend medical marijuana

Answer 144

High potential for abuse and abuse may lead to severe physical or psychological dependence Includes opium and many other opiates (including products containing hydrocodone); cocaine; stimulants such as amphetamine methamphetamine; depressants such as amobarbital, glutethimide, secobarbital, and pentobarbital

Answer 145

Lesser potential for abuse than C-II drugs, and abuse may lead to moderate or low physical dependence or high psychological dependence Includes many C-II drugs in combination with a noncontrolled ingredient, or in smaller dosages, or in a less abusable dosage form Also includes certain stimulants, anabolic steroids, dronabinol, ketamine, paregoric, and GHB approved by the FDA Strength limit of 1.8 g of codeine per 100 ml. Also strength limits for dihydrocodeinone, opium, morphine, and other drugs

Answer 146

Lower potential for abuse than C-III drugs, and abuse may lead to limited physical or psychological dependence Includes narcotic drugs such as dextropropoxyphene; depressants such as alprazolam, chloral hydrate, barbital, benzodiazepines; stimulants such as diethylpropion, phentermine; tramadol

Answer 147

Low potential for abuse relative to C-IV drug, and abuse may lead to limited physical or psychological dependence relative to C-IV drugs Includes antitussives containing codeine and antidiarrheals containing an opiate Strength limits of 200 mg of codeine per 100 ml; 100 mg of dihydrocodeine or opium per 100 ml; 1.5 mg of diphenoxylate; and not more than 25 mcg atropine per dosage unit

Answer 148

Scheduling authority is vested in the attorney general who must request a scientific and medical evaluation of the drug and recommendation from the secretary of DHHS. The recommendation of the secretary regarding scientific and medical issues is binding on AG, except when AG finds the drug must be placed in C-I to avoid an imminent hazard to public safety. The scheduling decision must be based on several factors.

Answer 149

Labels and labeling of commercial containers of controlled substances must contain the identification symbol of the schedule. The symbol must be prominently located.

Answer 150

Anyone who manufactures, distributes, or dispenses controlled substances (among others) must register with the DEA. Manufacturers and distributors must register annually; dispensers must register every 3 years. Exemptions from registration include agents or employees of registrants, common carriers, ultimate users, prescribers, and dispensers in the service of the U.S. government, and law enforcement officers.

Answer 151

Individual practitioners include physicians, dentists, veterinarians, or others licensed to dispense by the state. IPs who are agents or employees of another IP (other than a mid-level) may administer or dispense controlled substances, but not prescribe. IPs who are agents or employees of a hospital or other institution may administer, dispense, and prescribe controlled substances provided all requirements are met, including that the institution has assigned a specific internal code number to the IP as a suffix to the institution’s DEA number.

Answer 152

Manufacturing, distributing, reverse distributing, dispensing, conducting research, conducting narcotic treatment programs, conducting chemical analysis, importing, and exporting

Answer 153

Definition of dispense includes to deliver a CS pursuant to the lawful order of a practitioner; includes prescribing, administering, and dispensing Definition of practitioner includes physician, dentist, veterinarian, scientific investigator, pharmacy, pharmacist, hospital, or others licensed by their jurisdiction to be involved with controlled substances Definition of institutional practitioner includes hospitals, but not pharmacies Mid-level practitioners (including pharmacists) may register as dispensers, provided that state law authorizes independent or collaborative prescriptive authority.- PA’s, NP’s, not midwives

Answer 154

production, preparation, compounding, or processing of a drug; also, packaging, repackaging, labeling or relabeling Excludes activities of practitioners incidental to dispensing Manufacturer coincidental activities include: distributing its own products, chemical analysis, and preclinical research Pharmacies are exempt if engaged in the ordinary course of pharmacy practice. A pharmacy may manufacture and distribute to other practitioners aqueous or oleaginous solution or solid dosage form of a narcotic not exceeding 20% narcotic concentration.

Answer 155

Distributing: to deliver a CS Wholesalers must register as distributors. Practitioners registered to dispense are exempt, provided they comply with all conditions. Stocking of Automated Dispensing Systems in LTCF and return of CSs to suppliers by practitioners are exempt, provided recordkeeping requirements are met. Distributors are required to design and operate a system able to detect suspicious orders of CSs and inform the DEA upon discovery Controversy about whether delivery to the patient’s prescriber is distributing or dispensing

Answer 156

Coincidental activity of dispensers to conduct research with schedule II–V CSs if authorized Research with C-I drugs requires submission of protocols with application.

Answer 157

Each principal place of business where CSs are administered, dispensed, or stored requires separate registration.

Answer 158

May not engage in an activity where registration is required until registration is granted and a certificate of registration issued Current registrants should receive a registration form approximately 65 days before expiration. A second notice will be sent electronically if required. The dispenser registration form is DEA Form 224 (used to register with the DEA), which is available online.

Answer 159

Any modifications must be approved by the DEA. If the registrant dies or ceases legal existence, the DEA must be notified, and the registration terminated. Registrations cannot be assigned or terminated without DEA approval.

Answer 160

On discontinuance of business without transfer of business, the registrant must return a certificate of registration to the DEA for cancellation together with any unexecuted Form 222s. Controlled substances must be disposed of pursuant to regulations. If the registrant wishes to transfer business, a proposal must be submitted to the DEA at least 14 days prior to the transfer with the required information. The transfer may occur unless the DEA notifies otherwise. A complete inventory of CSs must be taken on the date of transfer. C-II products (like methylphenidate ) must be recorded via Form 222. Who completes the 222 forms: pharmacy, purchaser begins by completing the 222 forms, supplier completes the form and sends a copy to the DEA Pharmacy A acquiring B Turn in registration to the DEA To register as a new pharmacy, the DEA Form 224 must be completed.

Answer 161

The attorney general may deny a practitioner applicant a registration if it is determined not to be in the public interest, which requires the consideration of five factors. The AG may suspend or revoke a registration to manufacture, distribute, or dispense upon finding that the applicant materially falsified an application; has been convicted of a felony; or has had a state license or registration suspended, revoked, or denied.

Answer 162

All applicants and registrants must provide effective controls and procedures to guard against theft and diversion. The DEA considers several factors when evaluating the overall security system of a registrant or applicant. Individual practitioners must securely lock CSs in a substantially constructed cabinet. Pharmacies and institutional practitioners may do the same or disperse them throughout the stock of noncontrolled substances. May not employ any person whose application for registration has been denied or revoked

Answer 163

Section 841 establishes penalties for drug traffickers and is applicable to practitioners who prescribe and/or dispense outside of the ordinary course of professional practice. Section 842 establishes penalties for practitioners for not conforming to the requirements of the CSA, such as recordkeeping. The standard was changed from strict liability to negligence. Form 222 violations are subject to fines of up to tens of thousands of dollars and up to four years in prison. Knowingly or intentionally possessing a CS other than by a valid Rx could result in up to one year in prison and a fine of up to $1,000.

Answer 164

Constitutional issues The Fourth Amendment protects individuals from unreasonable searches and seizures. Requires the issuance of a search warrant based on probable cause The exclusionary rule provides that any evidence obtained in violation of the Fourth Amendment will not be admissible.

Answer 165

The DEA has the authority to inspect any place where CS records are kept or persons are registered. Allowed to examine and copy all records and reports (222 forms etc), inspect within reasonable limits, and take an inventory of CSs Without the consent of the owner or PIC (pharmacist in charge or manager record), the inspector is not allowed to inspect financial, sales (other than shipping), or pricing data The audit procedure involves inspecting records of drugs received less drugs dispersed and comparing them with inventory. Prior to the inspection, the inspector is required to state the purpose of the inspection and present the owner or PIC with credentials and written notice of inspection.

Answer 166

The NOI must contain the name of the owner or PIC, the name and address of the business, the date and time of inspection, and a statement that the NOI was given. The inspector must obtain a written statement of informed consent signed by the PIC or owner. Consent must be voluntary and not coerced and may be withdrawn at any time during the inspection. The PIC or owner can grant the inspector limited consent.

Answer 167

No consent required Probable cause requirement Valid public interest Contrast to probable cause for a search warrant (SW, which requires probable cause that you are doing something illegal) AIW was created by the Supreme Court as an alternative to SW AIW may only be served during regular business hours. Several exceptions exist as to when a warrant is not required.

Answer 168

Some states allow warrantless searches of pharmacies.– take a look at state laws! State warrantless search statutes may be constitutional, provided certain requirements are met.

Answer 169

Congress first authorized narcotic treatment programs (now OTPs) in 1974. Only LAAM, methadone (CII- a retail pharmacy can hold this for severe pain, cannot use for cough), buprenorphine, and buprenorphine containing products are authorized drugs for treatment of opioid addiction. Practitioners wanting to conduct maintenance or detox treatment must be registered by the DEA.

Answer 170

Used for severe pain outside of narcotic treatment programs Not legal to prescribe or dispense as an antitussive The APhA lawsuit established that the FDA could not restrict the distribution of methadone. Manufacturers voluntarily restricted 40 mg methadone tablets to OTPs. So, retail pharmacist usually have 5 or 10mgs

Answer 171

The purpose of the law is to make it a federal crime if robbery results in $500 or greater replacement cost of CSs, or a person suffers “significant” injury, or interstate commerce is involved in the planning or execution of the crime. Penalties can result in up to 20 years of imprisonment, $25,000 fine, or both. If a weapon is used, the penalties are higher. If death results, the penalty is higher yet.

Answer 172

Amends prior anabolic steroid (Testosterone etc) legislation enacted to prevent misuse in order to enhance athletic performance Maintains anabolic steroids as schedule III Adds several steroids to the act Provides for automatic scheduling of certain salts, esters, and ethers of anabolic steroids without need to prove muscle growth Physicians and prescribers cannot give for athletic performance

Answer 173

Places restrictions on OTC drugs used to manufacture methamphetamine including pseudoephedrine The law limits sale to no more than 3.6 g of ephedrine, PSE, or PPA base to a single purchaser per day. No consumer may purchase more than 9 g within a 30-day period or 7.5 g within a 30-day period by mail order. The products must be stored behind the counter or in a locked cabinet where customers do not have direct access. Sales must be recorded with required information. Many states have stricter laws. Limits pseudoephedrine age: no age requirement, each employee undergoes training that is certified to attorney general pseudoephedrine is 30mgs Know basic info: 3.6g per day 3.6 grams is 3600 mg 3600/30mg is 120 tablets Ask about pseudoephedrine base not hydrochloride or sulfate

Answer 174

Although electronic logbooks are not required, it is hoped that they will become the standard and that pharmacies will participate in common electronic logbooks. Sellers can now capture information by barcode reader. The seller or purchaser may enter the purchaser’s name, address, and date and time of sale. The seller may collect the purchaser’s signature by any of three means. Sellers must annually engage in self-certification.

Answer 175

CSs may be mailed, provided they meet the packaging standards established by the U.S. Postal Service. Can you mail drugs: yes Can mail CII-CV drug If you were not able to mail, there would be things as mail order pharmacy Label must not say that there are drugs inside

Answer 176

Defined as an order for medication dispensed to or for an ultimate user The Rx does not include orders for medication dispensed for immediate administration (i.e., hospital chart orders). Prohibition against prescriptions for office use

Answer 177

Individual practitioners (IPs) authorized to prescribe (or issue medication orders) in their state and registered by DEA or exempt from registration Employees or agents of IP may communicate prescriptions to a pharmacist or prepare the Rx for signature of IP Delegation of prescriptive authority not legal unless agent also has prescriptive authority When suspicious, might check the validity of a DEA number by performing the calculations or searching national database

Answer 178

Only a pharmacist acting in usual course of professional practice and who is registered individually or employed by a registered pharmacy or institutional practitioner Ancillary personnel may engage in CS dispensing activities if permitted by state law. IPs may dispense if permitted by state law.

Answer 179

Is authorized to prescribe controlled substances in the state in which he/she is licensed to practice; and Is registered or exempt from registration under 21 CFR 1306.03

Answer 180

a resident (new physician) will use the hospital’s DEA registration

Answer 181

Nine digits composed of letters and numbers two alphabet letters followed by seven numbers Initially, the registration number started with a letter A. All registration numbers starting with A have been assigned DEA started with B now F, started G

Answer 182

Mid-level practitioners (and pharmacist) begin with M. Distributors begin with either P or R The second letter is usually, but not always, the first letter of the registrant’s last name The next six positions are a computer-generated number unique to registrant The last and 9th position is a computer calculated check digit.

Answer 183

A pharmacist: adds the first, third and fifth digits adds the sum of the second, fourth and sixth digits, multiplied by 2, to the first sum determines whether the right most digit of this sum corresponds with the ninth check digit

Answer 184

Jane the pharmacist receives a prescription from Dr. William Nash. The DEA number on the prescription is AN1257218. Could this be a valid DEA number? A: physician N: first initial of last name Math: - 1 +2 + 5 = 8 - 2 + 7 + 1 = 10

Answer 185

1+5+2= 8 (2+7+1) x 2= 20 8+20 = 28 The 8 in 28 corresponds to the 8 in 18 This number could be valid * will need to make up your own DEA number and test if it could be valid*

Answer 186

In reality, many forgers are familiar with the procedure to verify a DEA registration number and can invent a number that would be plausible. Therefore, pharmacists cannot rely solely on this check to determine the validity of a controlled substance prescription.

Answer 187

Date of issuance required: no predating or postdating Must contain full name and address of patient; drug name, strength, dosage form, and quantity prescribed; directions for use; and name, address, and registration number of practitioner & DEA # Before filing, must contain written or typed name or initials of dispensing pharmacist, the date dispensed, and the units or volume dispensed The date is the date that they write a prescription

Answer 188

Must be signed on day of issuance Written in ink, indelible pencil (cannot erase), or typed and manually signed Corresponding responsibility of pharmacist and prescriber that a CS Rx complies with all requirements

Answer 189

Must include registration number of institution and special internal code number Must include name of prescriber stamped, typed, or hand printed, as well as signature of prescriber IPs in armed services or public health must include on the Rx the service ID number in place of the registration number.

Answer 190

For C-III, C-IV, and C-V Rxs, state law component: the pharmacist may add or change any information after consultation with practitioner and documentation, except for the patient’s name, name of CS (except generic substitution), or prescriber’s signature.—whatever the state allows For C-II Rxs: the DEA had traditionally maintained that additions or changes could be made the same as with other CS Rxs. That position has flip-flopped in recent years, but it appears corrections can be made if state law or policy permits.

Answer 191

A CS Rx must be for a legitimate medical purpose in the usual course of professional practice. Corresponding responsibility upon the pharmacist Knowingly prescribing or dispensing a CS Rx not for a legitimate medical purpose violates the law. “Knowingly” standard is one of a conscious disregard for the obvious. When suspicions should exist, a pharmacist is expected to exercise professional judgment and investigate. Legitimate medical purpose in the usual course of professional practice generally means acting in accordance with accepted standards of medical practice.

Answer 192

Examples of invalid prescriptions include: Narcotic Rxs written for the purpose of maintaining or detoxifying an addict Rxs written for fictitious patients Rxs written without a good-faith medical examination Rxs written when there is no medical reason A facially valid Rx is not necessarily a valid Rx. Pharmacists will more likely face enforcement action in situations where there is blatant or glaring misconduct as opposed to isolated prescriptions. DEA has published examples of situations that might be suspicious

Answer 193

Treatment of pain is a legitimate medical purpose. Drug tolerance and physical dependence as a consequence of opioid use is normal and natural. The quantity of drugs prescribed and frequency of Rxs alone are not indicators of improper prescribing. The pharmacists’ role under CSA is determining the legitimacy of Rx for pain rather than therapeutic appropriateness of using opioids.

Answer 194

Important to determine whether the purpose of opioid treatment is legally for pain or illegally for addiction Important to ascertain whether taper-down dosages are for detoxification of addiction or withdrawal due to physical dependence Important to distinguish addiction from dependence Exceptions allowing for treatment of addicts outside of licensed addiction programs or DATA

Answer 195

Alleged pain clinics create special concerns for pharmacists. Pharmacists should familiarize themselves with the medical standards of practice for diagnosing and treating pain. Pharmacists should seek a collaborative practice relationship with pain physicians. When necessary and appropriate, pharmacists should interview both the patient and prescriber regarding the pain and the treatment.

Answer 196

Overdose deaths in the U.S. continue to rise. Various federal and state efforts have been implemented to help address the epidemic, including prevention, treatment, and enforcement efforts. Examples of various efforts: prescribing guidances and laws, PDMPs, naloxone access, FDA REMS, medication disposal, expansion of partial fills, mandated electronic prescribing

Answer 197

General rule: C-II prescriptions must be written and signed by a prescriber. Some states have stricter laws, e.g., quantity limits, time limits, security Rx forms. Exceptions: Emergency situations Narcotic compounded drug for direct administration by infusion: faxed Rx serves as original Long-term care facility patients: faxed Rx serves as original Hospice patients for narcotic C-II drugs: faxed Rx serves as original Electronic (pursuant to requirements discussed later)

Answer 198

"Emergency situations", for the purpose of permitting the dispensing of any controlled substance in Schedule II upon orally or electronically transmitted prescription, means those situations in which the practitioner who intends to prescribe a controlled substance in Schedule II determines: (a) That the immediate administration of the controlled substance is necessary for the proper treatment of the intended ultimate user; (b) that no appropriate alternative treatment is available, including administration of a controlled substance which is not in Schedule II; and (c) that it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the controlled substance prior to the dispensing.

Answer 199

In case of an emergency situation, a pharmacist may dispense a controlled substance in Schedule II upon receiving the orally or electronically transmitted authorization of a prescribing practitioner, provided that: (a) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. (b) the prescription contains all information required by state lawexcept for the actual signature of the prescribing practitioner, and in the case of an oral prescription, or prescription transmitted electronically by computer modem or other similar electronic device, the prescription is immediately reduced to writing by the dispensing pharmacist; and (c) the dispensing pharmacist makes a reasonable good faith effort to determine that the orally or electronically transmitted authorization was issued by an authorized practitioner, which effort may include a callback to the prescribing practitioner or other good faith efforts to ensure the prescribing practitioner's identity.

Answer 200

The 2016 CARA law allows pharmacies to provide partial fills of a C-II medication up to 30 days from the date of the prescription if state law does not prohibit. CARA also allows partial fills of schedule II controlled substances when a pharmacist receives a verbal emergency prescription, with any remainder being provided within 72 hours. In LTCFs or for terminally ill patients, may partially fill for up to 60 days from date of issuance, provided recordkeeping requirements are met

Answer 201

Permitted provided: Each Rx must be on a separate blank. The total quantity prescribed does not exceed 90-day supply. The practitioner determines a legitimate medical purpose to do this. The practitioner writes instructions on each Rx (other than first) as to earliest date each Rx may be dispensed. Multiple Rxs do not create undue risk of diversion. Permissible under state law

Answer 202

May be dispensed pursuant to written, faxed (considered original), electronic, or oral order (need to be reduced to writing) Oral orders must be promptly reduced to writing. IPs may administer or dispense without a prescription.

Answer 203

For C-III and C-IV drugs: limit of 6 months after date of issuance or five times, whichever comes first The practitioner may orally authorize additional refills if original was written for less than five and authorization is recorded on hard copy or in automated system. The refill quantity cannot exceed quantity originally authorized.

Answer 204

If nonautomated system, must record required information on back of Rx or other readily retrievable document If automated system, must provide online retrieval either by display or hard copy printout of the original Rx information and up-to-date refill history Hard copy printout requirements In lieu of printout, may maintain bound logbook or separate refill file Records must be maintained for two years. Keep invoices for 2 years. Exceptions: Medicare Rx which is 10 years Pharmacies must have an auxiliary system for documenting refills if computerized system suffers downtime.

Answer 205

Permitted provided: Recorded in same manner as refill The total quantity dispensed does not exceed total prescribed. No dispensing after 6 months from date of issuance Important to differentiate partial fills from refills

Answer 206

The label must include date of filling if a C-II drug and date of initial filling if in another schedule. Refills should be labeled with both date of initial filling and date of dispensing. Labels must include all required information plus a cautionary statement prohibiting the ultimate user from transferring the drug. Labeling requirements are not applicable if prescribed for administration to an institutionalized patient, provided that restrictions and requirements are met.

Answer 207

Prescribers must: Undergo identity proofing Digitally sign using two of three possible factors for authentication An agent can enter Rx information but cannot have access to authentication factors and sign.

Answer 208

Pharmacy requirements: The pharmacy or ASP must digitally sign, and the pharmacy must archive the Rx. If Rx transmission fails, regulation establishes that certain requirements must be followed. May make changes to Rx after receipt Must back up daily and keep records for two years

Answer 209

All application systems must be approved by a third-party audit or certified by a DEA-approved entity.

Answer 210

CS Rx information (except C-II) may be transferred one time between pharmacies if state law allows and requirements are followed by both the transferring pharmacy and receiving pharmacy. Rx information sharing among pharmacies participating in common-electronic record systems is not subject to the transfer Rx requirements (CS Rxs may be transferred up to the maximum number of refills permitted).

Answer 211

Historically, the DEA forbade that CSs be returned by a patient or LTCF to a pharmacy for disposal. The Secure and Responsible Drug Disposal Act of 2010 allows an ultimate user to deliver to another person for disposal. DEA regulations in 2014 allow authorized entities, including pharmacies, to collect CSs from ultimate users, provided they register as a “collector.” Party doing destruction fill form 41

Answer 212

Pharmacies that fill Rxs for other retail pharmacies pursuant to contractual arrangement May fill both new and refill Rxs Any Rx dispensed for another pharmacy must be transported to that pharmacy for furnishing to patient. The label of the dispensed drug must indicate at which pharmacy the drug was dispensed. Cannot accept Rxs directly from patient or practitioner or deliver Rx directly to patient or practitioner Corresponding responsibility doctrine applies to pharmacists at both facilities.

Answer 213

Rogue internet pharmacy businesses are those that sell Rx medications to customers either without requiring Rxs or by issuing Rxs pursuant to online surveys. The Ryan Haight Act law defines a valid Rx as one that has been issued for a legitimate medical purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient. The act establishes several requirements with which online pharmacies must comply. Although the act only applies to CS Rxs, most states consider any Rx not dispensed pursuant to a legitimate physician–patient relationship as invalid

Answer 214

All states have a PDMP. A state PDMP requires a pharmacy to electronically transmit to the state a record of the CS Rx dispensed. Enables states to determine possible diversion and abuse situations Most PMPs allow or mandate practitioners to request patient-specific information. Many states share data between PDMPs.

Answer 215

LTC facilities (LTCFs) not registered with DEA DEA concerned about excess supplies of CSs and thus permits automated dispensing systems, partial filling, and voluntary collection receptacles by registered “collectors”

Answer 216

ADS is a mechanical system that stores, packages, counts, labels, and dispenses medications and maintains transaction information. The purpose is to reduce stocks of excess CSs in LTCFs. A pharmacy that installs ADS must maintain separate DEA registration at the LTCF location. Distributions that a pharmacy makes to ADSs do not count towards the pharmacy’s 5% limit which would require a separate registration as a distributor.

Answer 217

The DEA has changed positions as to whether LTCF nurses can be an agent of the prescriber. The latest Federal Register notice permits an agency relationship, provided there is a formal written, witnessed agreement. An agent may only perform certain acts.

Answer 218

LTCF emergency kits permitted The pharmacy is responsible for the kits. The DEA does not consider a nurse as an agent of the prescriber for this purpose. The prescriber must issue the prescription to the pharmacy and the pharmacist must authorize nurse to dispense from the kit.

Answer 219

Every registrant must keep a complete and accurate record of all CSs. Three types of records involved: Inventory Drugs received Drugs dispersed Negligent recordkeeping is a violation of the CSA.

Answer 220

Records generally must be kept for two years. Certain records may be kept at a central location with notification to the DEA. Centralized records require that the DEA be notified. Records must be able to be delivered to a registered location within two business days per DEA request. C-I and C-II records must be maintained separately unless readily retrievable.

Answer 221

Prior to beginning business and subsequently every two years, an inventory must be conducted containing a complete and accurate record of all CSs “on hand.” “On hand” means in possession of or under the control of the registrant. Inventory may be taken at the beginning or end of the business day; records must be written, typed, or printed. Newly scheduled drugs must be inventoried on the date of scheduling. The exact count must be made of C-I or C-II drugs. The estimated count is permissible for other schedules unless the container holds more than 1,000 units.

Answer 222

Acceptable records of receipt include invoices and Form 222. A pharmacy must record the date of receipt on the invoice or Form 222. If the invoice contains both CSs and nonCSs, the CSs must be identified in a manner so as to be readily retrievable. Records of receipt must contain all required information.

Answer 223

Acceptable records of dispersal include Rxs, record books, Form 222, invoices, records of disposal, theft or loss, etc. Prescriptions may be filed in one of two ways and each Rx must contain all required information.

Answer 224

In some states, C-V products may be sold without Rx, provided: Dispensing is done only by a pharmacist No more than 8 oz of an opium-containing product or 4 oz of any other CS may be dispensed to the same purchaser within a 48-hour period (some states have stricter requirements). The purchaser is at least 18 years of age. The purchaser furnishes suitable identification. The sale is recorded in a bound record book with all required information.

Answer 225

Invoice required for C-III, C-IV, and C-V products containing all required information Form 222 is required for C-II products The total number of dosage units distributed to another registrant must not exceed 5% of the total units of CSs distributed and dispensed in one year.

Answer 226

Medication or chart orders are distinguished from prescriptions and need only contain the minimum information necessary to provide an acceptable dispersal record. Must be readily retrievable Discharge medication orders may only be dispensed pursuant to Rx.

Answer 227

Must request via a DEA Form 41 (available online) and completed with the required information Form 41 does not apply to CSs collected from ultimate users or LTCFs. The DEA allows destruction pursuant to various options. “Blanket authorization” may be allowed for hospitals. A registrant may also transfer CSs to a reverse distributor.

Answer 228

A registrant must notify the DEA within one day of discovery of any “theft or significant loss” of any CS (should also notify police and most likely required to notify state board of pharmacy). The DEA has listed several factors to be considered in determining whether a loss is significant. A registrant must complete Form 106, which is available online.

Answer 229

Must keep records of CSs they dispense, but not of those they prescribe Need not keep records of CSs they administer unless the IP regularly engages in dispensing or administering and charges patients A record must be kept of CSs administered in the course of maintenance or detoxification of treatment of addiction. May administer or dispense CS without Rx

Answer 230

Required for any distribution of C-I or C-II drugs Forms obtained by requesting in writing from the nearest DEA office Forms issued in mailing envelopes containing 7 or 14 forms Each form is in triplicate titled Copy 1, Copy 2, Copy 3. just have 1 form now Forms are serially numbered and issued with the name, address, and registration number of the registrant, authorized activity, and schedules the registrant is authorized to handle. A registrant may not correct or change any information or errors on the forms.

Answer 231

All three copies must be executed simultaneously. Ten numbered lines on each form, only one item per line The number of the last lines completed must be noted on each form The form must contain the required information. The NDC number is optional (the supplier must enter it). Must be signed and dated by the authorized person The purchaser, upon receipt of the order, must record the number of containers received of each item and the date received. Partial order fills by the supplier must be completed within 60 days. Errors, alterations, or erasures are generally not permitted

Answer 232

Books of triplicate order forms would be replaced by a single-sheet tamper-resistant form. The purchaser would send the original completed form to the supplier after making and retaining a copy. The supplier would then send the original completed form to the DEA after making and retaining a copy.

Answer 233

May be used instead of Form 222 The purchaser can order any drug. The registrant must obtain a digital certificate for each DEA-registered location.

Answer 234

Required to allow person other than one who signed registration to execute Form 222

Answer 235

Whenever registrants distribute C-I or C-II drugs among themselves, they must execute a Form 222 following proper procedure.

Answer 236

If an unfilled order form is lost, the purchaser must execute another together with a statement noting the serial number of the lost form, the date of the lost form, and that the CSs were not received. Must maintain together Copy 3 of the second order form and lost order form with a statement The copy of the statement must be sent with Copies 1 and 2 to the supplier. If forms are stolen or lost other than in transmission, must notify the DEA and provide the serial # numbers of missing forms; if found, the DEA must be notified immediately

Answer 237

Executed Form 222s must be maintained separately from all other records and retained for two years. Copy 3 must be kept at the registered location.

pharmacy law exam 1 Flashcards

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