law
win the scope of practice (entire human body)
Physician - Naturopath -
Pharmacies that sell OTC products containing ephedrine and pseudoephedrine must be
"self-certified" as required by the Combat Methamphetamine Epidemic Act of 2005 (CMEA). The CMEA created a new category of products designated as SLCPs. SLCPs are products containing ephedrine, pseudoephedrine, or phenylpropanolamine that may be marketed or distributed lawfully in the United States as a non-prescription drug under the Food, Drug, and Cosmetic Act. The retail provisions of the CMEA went into effect on September 30, 2006 and require, among other things, employee training, self certification, placement of SLCPs out of customer reach, required identification, sales logbooks, sales and purchase limits, and others.
cosmetic
(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap. FDA
Sample distribution by mail or common carrier.
(a) Requirements for drug sample distribution by mail or common carrier. A manufacturer or authorized distributor of record may distribute a drug sample to a practitioner licensed to prescribe the drug that is to be sampled or, at the written request of a licensed practitioner, to the pharmacy of a hospital or other health care entity, by mail or common carrier, provided that: (1) The licensed practitioner executes and submits a written request to the manufacturer or authorized distributor of record, as set forth in paragraph (b) of this section, before the delivery of the drug sample; (2) The manufacturer or authorized distributor of record verifies with the appropriate State authority that the practitioner requesting the drug sample is licensed or authorized under State law to prescribe the drug product; (3) The recipient executes a written receipt, as set forth in paragraph (c) of this section, when the drug sample is delivered; and (4) The receipt is returned to the manufacturer or distributor from which the drug sample was received. (b) Contents of the written request form for delivery of samples by mail or common carrier. (1) A written request for a drug sample to be delivered by mail or common carrier to a licensed practitioner is required to contain the following: (i) The name, address, professional title, and signature of the practitioner making the request; (ii) The practitioner's State license or authorization number or, where a scheduled drug product is requested, the practitioner's Drug Enforcement Administration number. (iii) The proprietary or established name and the strength of the drug sample requested; (iv) The quantity requested; (v) The name of the manufacturer and the authorized distributor of record, if the drug sample is requested from an authorized distributor of record; and (vi) The date of the request. (2) A written request for a drug sample to be delivered by mail or common carrier to the pharmacy of a hospital or other health care entity is required to contain, in addition to all of the information in paragraph (b)(l) of this section, the name and address of the pharmacy of the hospital or other health care entity to which the drug sample is to be delivered. (c) Contents of the receipt to be completed upon delivery of a drug sample. The receipt is to be on a form designated by the manufacturer or distributor, and is required to contain the following: (1) If the drug sample is delivered to the licensed practitioner who requested it, the receipt is required to contain the name, address, professional title, and signature of the practitioner or the practitioner's designee who acknowledges delivery of the drug sample; the proprietary or established name and strength of the drug sample and the quantity of the drug sample delivered; and the date of the delivery. (2) If the drug sample is delivered to the pharmacy of a hospital or other health care entity at the request of a licensed practitioner, the receipt is required to contain the name and address of the requesting licensed practitioner; the name and address of the hospital or health care entity pharmacy designated to receive the drug sample; the name, address, professional title, and signature of the person acknowledging delivery of the drug sample; the proprietary or established name and strength of the drug sample; the quantity of the drug sample delivered; and the date of the delivery.
Which of the following indicates the most important category of new drug?
**2P
Pharmacist Jill is hired as RPM of indep pharm owned by non-pharmacist, Judy. Both Judy and Jill notify PQAC. 6 months later, Jill quits and Judy doesn't hire a replacement RPM, but instead relies on a series of pharmacists from a temp agency for an addtl 6 months. which is correct? a. jill may be subject to discipline b. judys pharmacy license may be subject to discipline c. both a and b may occur
**C
Which of the following is the basis for determining whether a particular product is subject to FDA jurisdiction?
**Its intended use
A pharmacy compounds an ointment which is sold to a physician, and which the physician sells to his patients
**b. The pharmacy is engaged in compounding drugs for wholesale **c. The pharmacy is manufacturing **d. 2 and 3: are both correct
a pharmacy sells a compounded nicotine lollipop. In WA, when a pharmacist compounds a nicotine lollipop for a specific pt, these are dispensing requirements
**need documentation that the pt agrees to the compounded rx
An ARNP in canada can dispense an rx to be filled in WA for?
**zyban lyrica neither
hospitals
- Must have director of pharmacy Appropriately qualified by education, training, and experience Each decentralized unit of a hospital pharmacy must have a pharmacist supervisor - Must have 24 H pharmacy services Policy for after-hours nurse access - Plan for emergency outpatient meds - Distribution of drugs - Administration of drugs - Investigational drugs - Additional responsibilities
Mid-level practitioners prescribing authority
- out of state prescriptions NOT allowed a. Nurse Anesthetists (CRNA) b. Optometrists (OD) c. Naturopaths (ND) d. Midwives (very limited) e. Pharmacists (R.Ph., Pharm.D.) under CDTA f. PT (R.P.T., Dr.P.T.) and Occupational Therapists (O.T., Dr.O.T.) - may not prescribe, but may order and use certain legend drugs. East Asian Medicine Practitioners (acupuncturists) - may NOT prescribe, but may order+ use certain sterile injectable drugs (eg, sterile saline, water for injection, vitamins) as part of tx
Abbreviated NDAs (ANDA) are filed by
-Manufacturers who wish to market generic versions of approved drugs after patent rights expire
Bills Acts statutes regulations codes state codes federal codes
-bills: proposals from legislators to be enacted -acts: bills that are appd by leg/congress -statutes: laws resulting from acts of a leg body that are signed into law by governor/president -regs: rules promulgated by an admin agency in accordance w powers granted to the agency by congresss/leg in a statute -codes: collecting and organizing statutes and regs -either RCW (statutes; eg: RCW 18.64.011)/WAC (reg; eg: WAc 246-863-100)
4 requirements of a valid controlled subst rx
-issued to an individual patient (or animal) -by an auth prescriber -in the due course of prescribers practice -issued in good faith for a legit med purpose
partial CIIs fills up to 60 days from date written when: -pharmacist is informed by prescriber that pt is terminally ill or -pt is in nursing home
-nursing home definition: WA law, "LTC facilities" include nursing homes, boarding homes, and adult family homes. (RCW 69.50.308(ii)) Fed regs define LTC facilities as: nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients.
device
...An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-- (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. FDA
PQAC requirements
10 pharmacists, licensed in WA for at least 5 years, geographically representative, and representing various areas of practice 4 public members, not affiliated with any aspect of pharmacy, citizens of US and resident of WA 1 pharmacy technician 4-year terms May serve 2 terms
Which of the following amendments to the federal Food, Drug, and Cosmetic Act created the legal distinction between legend (prescription) and nonlegend (nonprescription) drug products?
1951: Durham-Humphrey Amendment to the federal Food, Drug, and Cosmetic Act created the distinction between legend (prescription) and nonlegend (nonprescription) drugs. The amendment created this distinction by exempting certain drugs (legend drugs) from the "adequate directions for use" labeling requirement. After the amendment, legend drugs could be sold only by a pharmacy or other authorized dispenser pursuant to a prescription and could be dispensed in a container with a label that included directions for use. To distinguish legend from nonlegend drugs, the amendment required a commercial container of a legend drug to carry on the label the statement "Caution: Federal law prohibits dispensing without a prescription." This language was known as the "federal legend" and is the reason prescription drugs are also referred to as legend drugs. This statement was replaced with the "Rx Only" symbol by enactment of the Food and Drug Administration Modernization Act in 1997.
refer temp
2 deg C to 8 deg C (36-46 deg F)
A narcotic drug that contains a non-narcotic active medicinal ingredient and is a schedule V controlled substance is defined as any compound that does not have more than
200 mg of codeine per 100 mL of product. 100 mg of dihydrocodeine per 100 mL of product. 100 mg of opium per 100 g of product. The applicable DEA regulation is 21 CFR 1308.15 Schedule V.
The term very low sodium may be used in the labeling of OTCs intended for oral ingestion if the amount of sodium in the labeled maximum daily dose is ______ or less.
35mg The applicable DEA regulation is 21 CFR 201.64.
Which DEA form does a pharmacy use to register as a chemical distributor, thereby allowing the pharmacy to engage in the wholesale distribution of bulk quantities of SLCPs?
510 SLCP refers to a schedule listed chemical product. (DEA Pharmacist's Manual is Section III.)
At least how many days before introducing or delivering for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered must the manufacturer or distributor of that supplement, or of the new dietary ingredient, submit to the FDA information, including any citations to published articles, on which basis the manufacturer or distributor has concluded that the dietary supplement can reasonably be expected to be safe?
75 days The applicable section of the federal FDCA is 21 USC 350b.
label
A display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. FDA
Which of the following items is required to be on a pharmacy's biennial inventory of controlled substances?
A. Inventory date C. Inventory time (beginning or close of business)
For a retail pharmacy to transmit a prescription electronically to a central fill pharmacy, which of the following must happen?
A. The retail pharmacy must ensure that all information required to be on a prescription is transmitted to the central fill pharmacy. B. The retail pharmacy must write "CENTRAL FILL" on the face of the prescription. C. The retail pharmacy must maintain the original prescription for a period of 2 years from the date the prescription was last refilled. (DEA Pharmacist's Manual is Section XII)
The labeling for all OTCs intended for systemic absorption, unless specifically exempted, shall contain a general warning under the heading "Warning" as follows: " ask a health professional before use." In addition to the written warning, a symbol that conveys the intent of the warning may be used in labeling. This labeling policy applies to all of the following drug types except
A. drugs intended to benefit the fetus during pregnancy. B. drugs labeled exclusively for pediatric use. C. drugs intended to benefit a nursing infant.
Mid-level practitioners in WA prescribing allowances
ARNPs -Schedule II-V, in accordance with specialty area -May dispense up to a 72 hour supply of CSAs to own patients PAs - All schedules approved by supervising MD Optometrists - limited list, may include III, IV, V -No more than a 7-day supply of CSAs -No more than 30 dosage units of III or IV -Single doses of benzodiazepines for pre-procedure use Naturopaths - C-III and C-IV testosterone and codeine products Pharmacists - any schedule win scope of auth prescriber
preceptor requirements
Actively practicing in a Class "A" pharmacy. Been in active practice for at least 12 months prior to becoming a preceptor Completion of a Commission-approved preceptor training program Q 5 years May supervise more than one intern during a given time period; however, "two interns may not dispense concurrently under the direct supervision of the same preceptor"
which provision of RCW 18.64.011 makes it legal for a pharmacist to obtain blood from a patient's finger to use in a cholestek machine?
Administer - the direct application of a drug or device, whether by injection, inhalation, ingestion, or any other means to the body of a patient or research subject. MONITORING OF THERAPY - WAC 246-863-110 Collecting and reviewing patient drug histories Measuring and reviewing routine patient vital signs including, but not limited to, pulse, temperature, blood pressure, and respiration. Ordering and evaluating the results of laboratory tests relating to drug therapy blood chemistries and cell counts drug levels in blood, urine, tissue or other body fluids culture and sensitivity tests when performed in accordance with policies and procedures or protocols applicable to the practice setting, which have been developed by the pharmacist and prescribing practitioners which include appropriate mechanisms for reporting to the prescriber monitoring activities and results.
Which of the following is correct?
All RX oral drugs require CRCs, with a few exceptions
inspection grade 80-89
Conditional: 60 days to improve to Class A
Which federal agency regulates the Poison Prevention Packaging Act?
Consumer Product Safety Commission
Form for theft or loss of controlled substances
DEA Form 106
Form for purchase or transfer of schedule II controlled substances
DEA Form 222
Form for new application for registration.
DEA Form 224
Practitioners wishing to prescribe and dispense FDA approved schedule II controlled substances for maintenance and detoxification treatment must obtain a separate DEA registration as a narcotic treatment program. What is the form required for this registration? This activity also requires approval and certification by? Name of waiver ID #?
DEA Form 363 (separate DEA registration) Also requires the approval and certification by the Center for Substance Abuse Treatment (CSAT) within SAMHSA of the U.S. Department of Health and Human Services as well as the applicable state methadone authority. -unique DATA waiver ID #
Form for inventory of drugs submitted
DEA Form 41 21 CFR § 1307.21 (a) Any person in possession of any controlled substance and desiring or required to dispose of such substance may request assistance from the Special Agent in Charge of the Administration in the area in which the person is located for authority and instructions to dispose of such substance. The request should be made as follows: (1) If the person is a registrant, he/she shall list the controlled substance or substances which he/she desires to dispose of on DEA Form 41, and submit three copies of that form to the Special Agent in Charge in his/her area.
Filing of a New Drug Application (NDA)
Describes the drug, results of preclinical and clinical trials, proposed labeling, a Risk Management Plan, and describes manufacturing and testing processes. If the NDA is approved, the drug may be marketed.
The pharmacy exemption from the stringent labeling requirements imposed on pharmaceutical manufacturers does not apply to which of the following?
Drugs that are dispensed pursuant to a diagnosis by mail This provision is designed to protect consumers against fraud and quackery in situations where there is no physician-patient relationship because they are diagnosed and prescribed for by mail, or by means of the Internet. This provision does not apply to mail order pharmacies. If the prescription is a result of a diagnosis by mail or a diagnosis over the Internet, the dispenser must follow the labeling rules that apply to manufacturers. The FDA has ruled that the labeling requirements imposed on pharmacists do not apply to prescribers who dispense medication.
"Contraindication" clarified
FDA makes it clear that a "contraindication" IS a reason NOT to use the drug: "A drug should be contraindicated only in those clinical situations when risk clearly outweighs any possible therapeutic benefit. Only known hazards, and not theoretical possibilities, must be listed.
Pharmacist Betty Jones decides to open her own community pharmacy. Which of the following DEA forms will she use to apply for a DEA Certificate of Registration for the new pharmacy? Application form for a new DEA Certificate of registration
Fed law 224
DEA form that is the actual Certificate of Registration that must be conspicuously displayed at a pharmacy or other location registered with the DEA?
Fed law DEA Form 223
The US FDAC allows a physician to use an investigational drug for the diagnosis, monitoring, or treatment of a serious disease or condition in ER, provided that the physician determines both the pt has no comparable or satisfactory alternative therapy available AND the probable risk from the investigational drug is not greater than the probable risk from the disease or condition.
Fed law true The applicable section of the U.S. Code is found at 21 U.S.C. 360bbb.
Prescriptions written for opioids by an episodic care provider "shall include
ICD code and shall be written to require photo identification of the person picking up the prescription in order to fill." (WAC 246-919-859(3))
US Supreme Court Preemption Cases.
In 2008, the US Supreme Court took up 3 federal preemption cases relating to the FDCA. 1. In Riegel v. Medtronic, the Court held that the regulatory scheme for Class III medical devices explicitly preempts any State requirement relating to a regulated device concerning the safety or effectiveness of the device. 2. In Warner-Lambert v. Kent,8 the Chief Justice recused himself from participating in the decision due to his ownership of stock in Warner-Lambert's parent company, and the remaining 8 justices split 4-4. The divided court resulted in affirming of the 2nd Circuit's ruling that the plaintiffs could continue their lawsuit involving Rezulin® under Michigan law, by asserting that W-L obtained approval of Rezulin by fraud. 3. At the beginning of the 2008 Fall Term, the Court heard arguments in the case of Wyeth v. Levine.9 The plaintiff was injured by Phenergan® injection administered by IV push, and sued Wyeth alleging that IV push administration should not have been recommended in the package insert. Wyeth asserted that "FDA's comprehensive safety and efficacy authority under the FDCA preempts state law claims that different labeling judgments were necessary to make drugs reasonably safe for use." In 2009, the Court ruled that under the facts of Levine, the FDCA does not preempt state laws related to product liability. It held that the FDA's preemption preamble was in conflict with prior FDA positions, and that brand name drug manufacturers could improve the labeling of their products without violating FDA rules. 4. Subsequent trial and appellate court decisions have held that the FDCA does not preempt product liability suits against manufacturers of generic prescription drugs.10 The US Supreme Court, however, held in 2011 that the Hatch-Waxman Amendments to the FDCA, which establish labeling requirements for generic drugs, are more specific in requiring that all generic labeling must be identical to that of the brand name drug, thus it is impossible for generic manufacturers to simultaneously comply with state laws requiring them to improve or update their warnings and the requirements of federal law. Unlike brand name manufacturers, the Court held, generic manufacturers are not able to use the "Change Being Effected"(CBE) rule to modify their labeling. Thus, federal law was held to preempt state law suits against generic manufacturers arising from claims of defective labeling.11 Following this ruling, the FDA in 2013 proposed amendments to its rules that would allow generic manufacturers to use the CBE process to revise warnings on their labeling.
In 1984, the Controlled Substance Registrant Protection Act (CSRPA) was passed to protect DEA registrants against certain crimes. The CSRPA provides for the federal investigation of controlled substances thefts and robberies if which of the following events occurs?
Interstate commerce was involved in the execution of the crime A person was killed as a result of the crime The replacement cost of the controlled substances taken is $500 or more
WA authorizes these providers to prescribe all schedules
MD or DO DMD, DDS DVM - PodD, DPM - ARNPs - all schedules to extent authorized by their state to prescribe CSAs PA-C,Osteopathic PA- all schedules appd by sup physician Any of the above in any state in the US British Columbia physicians, NPs, and PAs, can prescribe legend drugs, but not controlled substances unless have a US-issued DEA No. "State" includes US territories (e.g., Guam, Puerto Rico)
Hospital Musts
MUSTS -Control of all drugs throughout hospital -->maintain perpetual inventories of schedule II drugs -Monthly inspections of all areas where drugs are stored or used -Monitoring of drug therapy -Provision of drug information
Frank Wilson, U.S. citizen, recently traveled outside the US. While outside the country, he became ill with a GI and suffered severe NVD, and dehydration. A physician in the town where he was located prescribed medications consisting of an antibiotic and two controlled substances. A local pharmacy dispensed the prescriptions, which were packaged, labeled, and dispensed in much the same manner as if dispensed in the United States. On returning to the United States 2 days after receiving the prescriptions, he proceeded to U.S. Customs, where he was asked if he was bringing any drugs into the country. He responded "yes" and handed the Customs officer the prescriptions. Regarding the controlled substance prescriptions, which of the following is true?
Mr. Wilson can legally bring a max of 50 dosage units + the two controlled substances into the US. The limit asstd with the exemption from import and export requirements for personal medical use is a combined 50 dosage units for personal use. Any individual who has in his/her possession a controlled substance listed in schedules II, III, IV, or V, lawfully obtained for personal medical use, or for administration to an animal accompanying may enter or depart the United States with such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C. 952-955), provided the following conditions are met: (a) The controlled substance is in the original container in which it was dispensed to the individual; and (b) The individual makes a declaration to an appropriate official of the Bureau of Customs and Border Protection stating: (1) The controlled substance is possessed for personal use, or for an animal accompanying; and (2) The trade or chemical name and the symbol designating the schedule of the controlled substance if it appears on the container label, or, if such name does not appear on the label, the name and address of the pharmacy or practitioner who dispensed the substance and the prescription number. The applicable DEA regulation is 21 CFR 1301.26.
Sample packages
Must: name of prescriber and the name of patient
New products are classified by the FDA using a rating scheme, which is indicated in information announcing the drug's approval.
New products are classified by the FDA using a rating scheme, which is indicated in information announcing the drug's approval. A number indicates the chemical type and a letter (P or S) indicates the therapeutic potential. The FDA considers 1P (New Chemical Entity that is a Therapeutic Advance) the most important kind of new drug: Chemical Type (1-6) a. 1 = New Chemical Entity (NCE), a novel chemical agent b. 2 = New salt or ester of a previously approved drug c. 3 = New formulation of previously approved drug(s) d. 4 = New combination of previously approved drugs e. 5 = Duplicate of another product f. 6 = Previously marketed by the same firm 2. Therapeutic Potential (P or S) a. P = Therapeutic advance i. No other effective drugs for the indication ii. More effective or safe than other drugs for the indication iii. Other important advantages compared to other drugs b. S = Similar to other drugs on the market for the condition
Individual provider rights
No pharmacist/physician may be compelled to participate in aid-in-dying No pharmacist/physician may be disciplined or otherwise adversely treated for participating in aid-in-dying Institutions and clinics may prohibit employees from participating on their premises Not clear if this exception applies to pharmacies
win the scope of practice (specialty area)
Nurse practitioner - Must state "ARNP" on Rx. Ex specialty areas: family practice (children and adults); psychiatric; pediatric; women's health; nurse midwife. Prescriptions for legend drugs and controlled substances MAY BE filled when issued by out-of-state ARNPs.
opinions of WA appelate corts can be found in
Pacific reporter
WA Death w dignity act
Terminally ill (6 mos) competent adult WA residents may request rx to end their lives in a dignified manner Must be certified x2 physicians=terminally ill & competent Must request a psychiatric evaluation if any question of mental incapacity Must be for a drug the patient can ingest by oneself No injectable drugs Physician may dispense drug(s) directly to patient, or, with patient's permission Physician contacts a willing pharmacist and explains nature of prescription Must deliver Rx directly to pharmacist or by FAX Pharmacist must deliver Rx directly to physician, patient, or agent specified in the Rx
Dea Form 41
The breakage or spillage of controlled substances does not constitute a "loss" of controlled substances and must be reported on DEA Form 41 (Registrants Inventory of Drugs Surrendered)
The federal FDCA defines the term drug as an article listed in official compendia. Which of the following is not one of the recognized compendia listed in this definition?
The definitions of drug and official compendium are found in 21 USC 321. A. Homeopathic Pharmacopeia of the United States NO B. National Formulary NO C. United States Pharmacopeia NO D. Tyler's Honest Herbal YES E. Any supplement to any of the official compendia NO
official compendium
The official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them. FDA
For a pharmacy to receive drug samples, which of the following statements must be true?
The pharmacy must be in a hospital or other health care entity. A licensed prescriber must request the samples in writing.
A physician in a same-day surgery center wants to have morphine on hand in her office. How may she get that morphine from your pharmacy?
The physician may order it on DEA Form 222, issued by the surgery center. The person or entity ordering the morphine is the person or entity that must fill out DEA Form 222. It is not acceptable for the pharmacy to use its own DEA Form 222 to complete the transaction. The pharmacy must complete the information as the supplier on DEA Form 222, but the pharmacy may not initiate the paperwork. The applicable sections of the DEA Pharmacist's Manual are Section IX and Section XIII.
Corresponding responsibility of the pharmacist
The prescriber bears the primary responsibility for the legitimacy of his or her prescriptions, the law holds the pharmacist to a "corresponding responsibility" for recognizing invalid prescriptions, when the pharmacist "knew or should have known" from the circumstances that the prescription was not issued in the due course of practice for a legit med purpose.
When requesting a drug sample, a prescriber must provide which of the following items?
The prescriber's actual signature
What is expiration date for a prescription written for Ritalin (methylphenidate) 10 mg? BOTH: fed and WA
There is no federal time limit. WA=6 month expiration after date written
A product that is both a cosmetic and a drug
This may happen when a product has two intended uses. Ex: a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. eg: toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.
pharm assistants can
Type, fill, refill, bookkeep, price, stock, deliver, phone inquiries (non-professional), third party reimbursement documentation May NOT enter data into the computer system
RPM
Unlawful to operate a pharmacy without placing a pharmacist in charge (RCW 18.64.020) Each non-licensed proprietor must appoint a responsible pharmacist manager (RPM) Must notify Commission when appointed Must notify Commission when appointment is terminated Each RPM must notify Commission when appointed or appointment terminated "Every portion of the establishment coming under the jurisdiction of the pharmacy laws shall be under the full and complete control [of the RPM]." (WAC 246-869-070) Example: Commission held an RPM responsible for inappropriate labeling on OTCs in the front section of a larger pharmacy RPM responsible for ancillary personnel.
inspection grade <80
Unsatisfactory: 14 days to improve to Class A 5 pts + taken off for violation of ancillary personnel rules automatic Unsatisfactory grade Self-inspection procedures
requirements for pharm tech licensure in WA after 1-1-09
WA techs licensed after January 1, 2009 must have passed a natnl exam (PTCE, or ExCPT) Do not need to maintain CPhT status must have: high school diploma/GED Will need to complete CE (9 H related to pharmacy practice and directed to technicians) 1 hour related to law
A patient has a prescription for 20 tablets of alprazolam 1 mg, 1 tid prn for anxiety, with 5 refills. She wants to pick up 10 tablets every week. Which of the following statements is correct?
WA: 6 mo/5 refills/may partially fill C-III or C-IV rxs in quantities less than the original prescription, and these partial fills do not count as "refills" within the 5-refill limit, provided that: a. No partial fills are dispensed after 6 months b. The total quantity dispensed by the original and all partial fills does not exceed the total quantity authorized on the prescription. Fed: The patient will receive 10 tablets a week up to the 120 tablets originally prescribed & exp=6 mo from date written
CIIs: Refilling prescriptions; issuance of multiple prescriptions.
WA: same federal: §1306.12 NO refills allowed An individual practitioner may issue multiple prescriptions to receive a total <90-day supply provided the following conditions are met: (i) Legitimate medical purpose acting in the usual course of professional practice; (ii) Provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription; (iii) Does not create an undue risk of diversion or abuse;
the citation, 21 USC $ 331, refers to
a section of the federal food, drug, and cosmetic act
Federal preemption of state laws (3) When Congress passes a federal statute in an area of its authority (for example, to regulate interstate commerce), federal law preempts state laws governing the same conduct, unless the federal statute allows for states to create their own laws.
a. Explicit preemption. Congress includes specific language in statute that preempts state law, which may include language that certain types of state law are allowed. i. For example, the Device Amendments to the FDCA (see Chapter 4) explicitly preempt state regulation of medical devices (21 U.S.C. § 360k(a)): "Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." ii. An example of a federal statute that allows some state regulation is HIPAA (Public Law 104-191, 104th Congress), which explicitly preempts state laws that are in conflict, but specifically allows the Secretary of the Department of Health and Human Services to permit state laws or regulations that are more stringent in protecting patient privacy (see section 1178 of the Act.) b. Conflict preemption. Congress is not explicit about a statute preempting any state regulation, conflict between state and fed law may result. Either it will be impossible for a person to simultaneously comply with federal and state law, or it may be found that the state law interferes with the achievement of the goal or objective of federal law. i.i. The Hatch-Waxman amendments to the FDCA restrict generic manufacturers to labeling their products exactly in accordance with the label approved by the FDA for the originator's product/with a class label approved by the FDA. State lawsuits alleging product liability typically argue that the labeling of the product should have been better at warning the plaintiff of the dangers of the drug. Because a generic manufacturer cannot simultaneously comply with the Hatch-Waxman requirements and with a stronger label under state product liability law, state product liability lawsuits based on label warnings have previously been held to be preempted. c. Field Preemption. When federal law has been held to "occupy the field" and it is apparent that Congress intended the law to preempt state law. i. Federal courts have repeatedly held that when Congress passed the Employee Retirement Income Security Act (ERISA), it intended to "occupy the field" of employment benefit law for plans subject to the Act. As discussed in
criminal law evidentiary standard
beyond a reasonable doubt
Pharmacy Commission Jurisdiction
can discipline: pharmacists, interns, pharm techs, assts, wholesalers, and others who are required to be licensed by the commission
A life-supporting or life-sustaining device that requires FDA approval before it can be marketed in interstate commerce in the US is a
class III device The federal FDCA provides for three classes of medical devices: class I, class II, and class III. Generally, class I devices are not subject to premarket approval, and class II devices are subject to performance standards. Class III devices are life-supporting or life-sustaining devices and require premarket approval by FDA. The applicable section of the federal FDCA is 21 USC 360c.
admin law evidentiary standard
clear, cognent, and convincing or preponderance of evidence
Practitioners wishing to prescribe and dispense FDA approved schedule II controlled substances for maintenance and detox tx must obtain a separate DEA registration as a narcotic tx program. Which of the following forms is required for this registration?
fed DEA Form 363
Define: orphan drug, a rare disease or condition is defined as follows: a disease or condition that affects (a) fewer than ______ persons in the US or (b) more than _____ persons in the US provided that there is no reasonable expectation that the cost of developing and making the drug available will be recovered.
fed 200,000
The Combat Methamphetamine Epidemic Act of 2005 places limits on the sale of nonprescription drugs containing pseudoephedrine, ephedrine, and phenylpropanolamine. Limits? Also, pharmacies that sell OTCs containing pseudoephedrine must...
fed 3.6 g per day & limited to 9 g/ 30 day period -be self-certified with the DEA. (DEA Pharmacist's Manual is Section III)
A pharmacist sells a schedule V controlled substance wout a rx in a state where such a sale is allowed. What information is required to be in the logbook recording this sale?
fed The name and address of the purchaser The name or initials of the pharmacist who dispensed the substance to the purchaser
The first generic version of a branded drug is granted an exclusivity period. How long is this exclusivity period?
fed 180Days
A physician writes a prescription for 100 tablets of hydromorphone 4 mg. She notes on the prescription that the patient is terminally ill. How long does the pharmacist have to dispense in partial quantities up to the 100 tablets ordered?
fed The pharmacist may partially fill the prescription for 60 days (the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed). Rx valid up to 60 days after the issue date. (DEA Pharmacist's Manual is Section X)
The DEA will allow a retail pharmacy to register at the site of a LTC facility and store controlled substances in an automated dispensing system in that facility.
fed law The statement is true, and the applicable section of the DEA Pharmacist's Manual is Section XII.
Before a manufacturer of prescription drugs may distribute (either through its representatives directly or through an authorized distributor of record) prescription drug samples to any person allowed to receive samples under federal law, a written request must be submitted to the manufacturer by the person requesting the samples.
fed law true The applicable FDA regulations are 21 CFR 203.30 and 21 CFR 203.31.
A drug is misbranded if
incomplete or misleading LABELING. Repackaging an OTC drug without supplying all the information contained on the original bottle is a form of misbranding. Failure to dispense a patient package insert or Medication Guide, unless specifically directed to withhold it by the prescriber, is considered misbranding. If pt requests a Medication Guide, it must be provided, even if the prescriber has directed otherwise (21 CFR 208.26(b))
civil law applies to
matters between private parties (torts, contracts) Torts= intentional, harmful acts committed by one individual upon another//contracts=voluntary agreements between capable parties)
Who can prescribe legend and controlled subs in all states?
physicians, podiatrists, dentists, and veterinarians
civil law evidentiary standard
preponderance of evidence
Retail Pharmacist receives an emergency oral prescription for a schedule II drug. After determining all the criteria have been met for an emergency, Pharmacist calls Central Fill Pharmacist to have the prescription filled. What is Central Fill Pharmacist's preferred course of action?
refuse to fill 21 CFR § 1306.11(d)(5). Central fill pharmacies are not authorized to prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from a retail pharmacist or an individual practitioner.
pharmcists serving nursing homes who take mcare or mcaid pts must
review the drug regimen of every pt at least Q 30 days
which of the following are used in nursing homes only if the home uses a unit-dose distribution system
supplemental dose kits
Supplemental NDAs are filed when
the manufacturer seeks additional indications or changes in the labeling or production of the drug.
admin law applies to
violations of admin law and regulations by licensees
criminal law applies to
violations of criminal statutes, enforced by state
While taking inventory, Pharmacist clears out expired stock, including a large number of controlled substances. What is Pharmacist's preferred course of action?
Request authorization and instructions from the DEA on how to dispose of the expired stock using DEA Form 41. (a) Any person in possession of any controlled substance and desiring or required to dispose of such substance may request assistance from the Special Agent in Charge of the Administration in the area in which the person is located for authority and instructions to dispose of such substance. The request should be made as follows: (1) If the person is a registrant, he/she shall list the controlled substance or substances which he/she desires to dispose of on DEA Form 41, and submit three copies of that form to the Special Agent in Charge in his/her area.
nursing home csa rules
Requirements depend requirements depend on UD or non-UD CSA schedule must be on label of CSAs dispensed to nursing home patients Non-unit dose systems C-II stored separately under lock C-III stored separately from other drugs but may be stored with C-II Bound log book for all C-II or C-III drugs Physical counts -->Q 24 H (C-II) -->weekly (C-III) See text for rules about discharge or destruction Unit dose - may follow above rules or develop alternative system with equivalent record keeping C-III unit dose may be stored with other UD drugs D/c unit dose drugs OTHER than C-II may be returned to pharmacy
A pharmaceutical company that originally developed the drug wants to lengthen the expiration date based upon additional stability data. Which of the following must the company submit to the FDA?
SNDA A Supplemental New Drug Application. An easy way to remember this is to know that if the Same company that original drug is submitting the application, a Supplemental New Drug Application is required. On the other hand, if Another company is submitting an application, it must be an Abbreviated New Drug Application.
Patient Information Leaflets (PILs)
Supplementary information sheets provided by pharmacies as part of the prescription process. WA requires that written information accompany prescriptions that are delivered outside the confines of the pharmacy, and it is a national standard of practice to provide written material to patients that expands and reinforces the information they need to properly use their drugs, which should also be communicated during pt counseling
