Law Exam 1 Class 2
"Wholesaler" Entities in Connecticut [CGS 20-571]: "Virtual wholesale distributor"
brokers/facilitates transfer of drugs/devices/cosmetics without taking physical possession
FDA Registration for drugs, biologicals, medical devices
An establishment is required to register with the FDA if, in the United States, the establishment: manufactures, repacks, or re-labels human or animal drug products, or biological products (including vaccines) produces or distributes medical devices manufactures human cells, tissue, and cellular and tissue-based products (HCT/Ps) In addition to registration, these establishments have certain reporting requirements
Definition of "compound" from Connecticut's Pharmacy Practice Act"
As used in this section [21 USC 353a], the term "compounding" does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling. FDA: compounded drugs are NOT approved drugs Cannot do it prospectively Cannot manufacturer it Must be patient specific
Biosimilar: FDA process
FDA approval for same indication(s) and conditions of use as reference product if biological product has: Same MOA Route(s) of Administration Dosage form(s) Strength(s)
DSCSA: Dispensers and Regulators
Upon request, provide regulators with transaction information, transaction history, and transaction statements for recalls & investigations of suspect product
Federal Track & Trace (DSCSA) Requirements: A Dispenser Must [trading partners]
Use only licensed/registered Trading Partners to purchase finished form prescription drugs for humans
Biological product
generally derived from a living organism (e.g., humans, animals, microorganisms, yeast)
"Pharmacy" (CT)
means a place of business where drugs and devices may be sold at retail and for which a pharmacy license has been issued to an applicant under the provisions of section 20-594;
Drug [CGS, USC]
(A) articles recognized in the USP-NF, Homeopathic Pharmacopoeia of the United States (HPUS), or any supplement to any of them; (B) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; (C) articles, other than food, intended to affect the structure or any function of the body of humans or any other animal; and (D) articles intended for use as a component of any articles specified in this subdivision; but shall not include devices or their components, parts or accessories
FDA Equivalency Rating Codes (Orange Book)
"A" rated products: bioequivalent and "therapeutically equivalent" to brand name/reference product AA Conventional dosage forms (tabs, caps) AN Solutions and powders for aerosolization AO Injectable products with oil solvents AP Injectable solutions AT Topical Products (if same dosage form) "B" rated products: products that are not bioequivalent "AB" rated products: Product meets "necessary bioequivalence" requirements and may be substituted if equivalency problem resolved by in vivo and/or in vitro studies
suspicious orders
"Suspicious order" includes unusual size, deviating substantially from a normal pattern, or unusual frequency
biosimilar
A biological product that is highly similar to a reference product, notwithstanding minor differences in clinically active components No clinically meaningful differences in terms of safety purity and potency
Device: Federal Definition
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-- recognized in the official USP-NF, or any supplement to them, 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 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
Biologic License Application
Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.
Biosimilar definition
Biosimilar product has "no clinically meaningful differences" from reference product for safety, purity and potency as demonstrated through: Pharmacokinetic studies (exposure) Pharmacodynamic studies (response)
DSCSA: What's NOT Covered
Blood or blood components intended for transfusion Radioactive drugs or biologics Imaging drugs Certain IV Products Medical gas Homeopathic drugs Lawfully compounded drugs
Investigational New Drug (IND)
Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA
Federal Track & Trace (DSCSA) Requirements: A Dispenser Must [suspect products]
Quarantine & investigate "suspect" products Keep investigation records for suspect drug 6 years Keep records of product identified as illegitimate for 6 years
Priority Review
Therapy must show significant improvement over current standards Applicant requests priority review, and FDA acts on request within 60 days If granted priority review, FDA acts on NDA/BLA/Efficacy Supplement within 6 months
MedWatch Program [USC]: Reporting
Voluntary for healthcare professionals and consumers But should not report problems with vaccines, tobacco, investigational drugs, dietary supplements, veterinary products Mandatory for IND reporters, manufacturers, distributors, importers, and user facilities (devices) [can include hospitals with medical devices]
Dispense (Connecticut)
"Dispense" means those acts of processing a drug or device for delivery or for administration for a patient pursuant to a prescription consisting of: (A) Comparing the directions on the label with the directions on the prescription to determine accuracy; (B) the selection of the drug or device from stock to fill the prescription; (C) the counting, measuring, compounding or preparation of the drug or device; (D) the placing of the drug or device in the proper container; (E) the affixing of the label to the container; and (F) the addition to a written prescription of any required notations. "Dispense" does not include the acts of delivering a drug or device to a patient or of administering the drug or device to the patient
Drug Wholesalers and Manufacturers [CGS 21a-70]: Wholesaler
(a/k/a distributor) is an entity that sells or supplies to other wholesalers, manufacturers, distributors, hospitals, prescribers, pharmacies, government agencies, clinics or other authorized entities includes medical device and oxygen providers, third-party logistics providers, virtual manufacturer/wholesale distributor
A Drug is Misbranded if... [21 USC 352, CGS 21a-106; RCSA 21a-115-16 to RCSA 21a-115-21]
(think label) Label fails to contain required information If in package form, must contain: name and place of manufacturer or packer/distributor Accurate quantity Label is false or misleading Fraudulent or exaggerated claims e.g., labeling promotes a use that is not FDA-approved Omission of pertinent information (e.g., "Rx Only", temperature requirements, etc) Inconspicuous printing (e.g., generic name appears in font smaller than half the font size of proprietary name of prescription drug) It is recognized in an official compendium but does not conform to the compendium's labeling (e.g., missing statement of required refrigeration) It offers sale of a drug under the name of another drug The drug would be dangerous to use as labeled It does NOT contain a product identifier as required under the Drug Supply Chain Safety Act (DSCSA)
6 Factors Considered by FDA for REMS to be Required [21 USC 355-1]
1. The seriousness and nature of known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug. 2. The expected benefit of the drug with respect to the disease or condition. 3. The seriousness of the disease or condition to be treated. 4. Whether the drug is a new molecular entity. 5. The expected or actual duration of treatment with the drug. 6. The estimated size of the population likely to use the drug
There are two regulatory pathways to bring a nonprescription (OTC) drug to market in the US
1. drug application process For new chemical component: taken to market by NDA ⇒ prescription only ⇒ data collected ⇒ apply to FDA as OTC product (need adequate directions for use) 2. over-the-counter (OTC) drug review (OTC monograph) process Rule book for what should be in a packet for OTC Need to meet standards within monograph, can just market the product
Federal Track & Trace (DSCSA) Requirements
10-year timeline to "track & trace" drugs by "Trading Partner" Categories of Trading Partners are: Manufacturers; Wholesalers, Repackagers, and Dispensers Preempts state "pedigree" requirements
Counterfeit Drug: CT Definition
A controlled substance which, or the container or labeling of which: without authorization bears the trademark, trade name, or any other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug
Dietary Supplement
A dietary supplement is a product (other than tobacco) that Is intended to supplement the diet; and Contains ≥1 dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their constituents; and is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is labeled on the front panel as being a dietary supplement. Regulated differently than foods and drugs Classification as a dietary supplement, conventional food, or drug is based on intended use Most often, classification as a dietary supplement is determined by manufacturer's product label or accompanying literature
When Repackaged is Not Misbranded [CGS 20-618]
A drug is not considered misbranded when repackaged by a pharmacy into stock packages for use within the pharmacy if properly labeled. Label must contain: drug name drug strength lot number manufacturer expiration date, if any
Counterfeit Drug: Federal
A drug which, or the container or labeling of which: without authorization bears the trademark, trade name, or any other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug
DSCSA: Dispensers must accept
Accept only prescription drugs that have transaction information, transaction history, and a transaction statement (manufacturers & wholesalers were to start providing this "pedigree" information to wholesalers and direct buyers as of January 1, 2015)
DSCSA: Dispensers must
Accept, Transfer Keep that information for 6 years & make available to regulators
A drug manufacturer includes in its oral solution of a color additive that is NOT FDA approved. The FDA could remove the product from the market because it is:
Adulterated
Abbreviated New Drug Application (ANDA)
An Abbreviated New Drug Application (ANDA) contains data that provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug).
OTC monograph
An OTC monograph is a "rule book" for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which an OTC drug is generally recognized as safe and effective (GRASE) and can be marketed without a New Drug Application (NDA) and FDA pre-market approval. Nonprescription drug products marketed under the OTC Drug Review are referred to as OTC monograph drugs.
DSCSA: Packages without product identifiers
Excluded products Grandfathered Waiver, exception or exemption
NDA approval process
Chemistry Manufacturing Controls Labeling Testing Animal studies Clinical studies Bioavailability
ANDA approval process
Chemistry Manufacturing Controls Labeling Testing Bioequivalence
Epinephrine Auto-Injector Distribution: Businesses and other Orgs
Connecticut law also allows businesses and other organizations (e.g., restaurants, workplaces) to legally purchase epinephrine auto-injectors from wholesalers, provided the "authorized entity" has: a medical protocol with a licensed practitioner at least one employee with appropriate training required records that are maintained Procedures for handling emergency medical situations involving anaphylactic allergic reactions
Epinephrine Auto-Injector Distribution: Schools
Connecticut law requires public schools "to maintain epinephrine in cartridge injectors for the purpose of emergency first aid to students who experience allergic reactions" Pharmacies: Some can distribute to schools because it has a wholesaler license Wholesaler can distribute to schools
Poison Prevention Packaging Act (PPPA) [16 CFR 1700.14(a)(10)]: Inpatient
Does NOT apply to inpatient settings (e.g., hospital, SNF) where healthcare professional administers the medication
Poison Prevention Packaging Act (PPPA) [16 CFR 1700.14(a)(10)]: Exempt
Drug is exempt or in special/exempt packaging Sublingual nitroglycerin Unit dose potassium supplements Oral contraceptives in special dispensers Medrol Dosepak
FDA Recall Authority [21 CFR Part 7, Subpart C]: Class 1
Drug product may cause serious adverse health consequences including death, the recall should include stocks in pharmacies and notification of patients to whom drug has been dispensed
FDA Recall Authority [21 CFR Part 7, Subpart C]: Class 2
Drug product may cause temporary or reversible effects but probability of serious adverse effects is remote - recall usually includes stock in pharmacies
National Drug Code (NDC) Numbers [21 USC 360]: NDC Number
Drug products are identified and reported using a unique, three-segment number (total of 10 digits), called the National Drug Code (NDC), which serves as a universal product identifier for drugs. NDC number is not required on commercial product label The three segments of the NDC number are: mfr/packager - product - package size
DSCSA: Manufacturers/Repackagers
Encode product identifiers on prescription drug packages determine smallest individual saleable unit verification requirements changes once products are serialized with product identifier
DSCSA: Dispensers must transfer
Except when dispensing to patients, making returns, or selling to another dispenser for "a specific patient need" (i.e., an identified patient) Provide the transaction information, transaction history, and transaction statement for any prescription drug where ownership/possession is transferred (note: a transaction history contains all of the transaction information received from upstream Trading Partners) Dispenser may return product to Trading Partner product was acquired from without providing transaction information
DSCSA Replaces Pedigree Requirements
FDA takes dominance over state laws even if the state law is more strict because the FDA needs to be able to regulate the drug labels A note about the NABP's MPJE competency statement 1.2.1 Under CGS 21a-70c, Connecticut created a working group in 2011 to look into establishing a pedigree program for prescription drugs distributed in the State. DSCSA became effective 01/01/2015 DSCSA "preempts" any state law in conflict with it Connecticut has not implemented any separate (non-conflicting) requirements for authenticating drugs distributed in Connecticut
Fast Track
Fills an unmet need or shows advantage over existing therapy Must be requested by applicant FDA acts on request within 60 days
Biosimilar vs Generic
Generic drugs are small molecules with the active component quality and quantity identical to the reference product Biologic drugs are too large and complex to replicate identically Biologic drug typical traits include --1000 x larger than small molecule generics --produced in living systems --protein folding --post-translational modifications (glycosylation) --multiple levels of structure --higher immunogenic potential, produced --sensitive to physical conditions
Right to Try Laws
I as a patient have the right to try a drug for my condition In certain states: States can force hospitals/providers/pharmacists to dispense medications to patients Expedited review helps prevent right to try laws Try to balance the need for new meds and safety Does not qualify under VIS
Federal Track & Trace (DSCSA) Requirements: A Dispenser Must [illegitimate products]
Identify & remove "illegitimate" products (e.g., counterfeited, diverted, unsafe) Notify FDA and Trading Partners of illegitimate product within 24 hours Coordinate with manufacturer for disposition of product Upon manufacturer's or regulator's request, retain a sample for exam/analysis
Poison Prevention Packaging Act (PPPA) [16 CFR 1700.14(a)(10)]: OTC Multiple Package Sizes
If OTC in multiple package sizes, mfr/packer is allowed one size that is not CRP - but must contain statement: "This package for households without young children" If package is too small to accommodate that statement, must state: "Package Not Child-Resistant"
Medication Guide Enforcement Discretion Policy: Certain times when it is not required to give medication guides
Impatient (UNLESS patient/agent request OR REMS) Outpatient to HCP for Pt admin each time drug is dispensed All other situations ⇒ MUST provide medication guide
Device: CT definition
Instruments, apparatus, and contrivances including their components, parts or accessories used: in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals, or to affect the structure or function of body of humans or other animals (FDCA definition also says that the mechanism of action must not be chemical or metabolic)
Interchangeable
Interchangeable product is a biosimilar that has also shown it is expected to produce "same clinical result" If administered more than once, manufacturer must evaluate safety and efficacy of switching back and forth (at least 3 times) between reference product and interchangeable product
DSCSA: Transactions
Involve transfers of product where a change of ownership occurs
Trading Partners under DSCSA
Manufacturers Repackagers Wholesale Distributors (WDDs) Dispensers (primarily pharmacies) Third-party logistics providers (3PLs)
Manufacturers and wholesalers may distribute only to:
Manufacturers Wholesalers/distributors Hospitals Prescribing practitioners Pharmacies Government agencies Clinics Or as otherwise permitted by statute (e.g., nonlegend drug permit holders; "epinephrine cartridge injectors" to "authorized entity") Basically: Can distribute to another entity that is subject to rules & regulations Can NOT distribute directly to patient
Registration of Manufacturers and Wholesalers
Manufacturers and wholesalers (a/k/a distributors) must register with DCP to operate in Connecticut
MANUFACTURING vs. COMPOUNDING
Manufacturing - is FDA regulated and requires: specific labeling cGMP drug approval process Compounding - is regulated by the States as the practice of pharmacy
Drug Wholesalers and Manufacturers [CGS 21a-70]: Registration
Must register with DCP as a wholesaler or manufacturer to distribute drugs, medical devices or cosmetics (unless otherwise authorized) Must have a system to identify, and report to DCP, suspicious orders Must report to DCP any suspicious orders reported to DEA Must report to DCP (within 5 business days) any practitioner/pharmacy that, because of potential diversion concerns, wholesaler/manufacturer ceases or declines to distribute any CII-CV
DSCSA: Product Identifier
NDC Serial Number Lot number Expiration Date
Manufacturer Labeling [21 USC 321(m); 21 CFR Part 201] Manufacturer's container for drug must state:
Name & address of manufacturer/packer/distributor (does not apply to biological drug products approved under Public Health Services Act) Established name of drug/drug product (USP/USAN) Net quantity Weight of API per dosage unit (if electrolyte, must also state concentration as mEq) Inactive ingredients (in alphabetical order) Flavoring agents and perfumes may be listed by common name If Rx only: Federal legend "Caution: Federal law prohibits dispensing without a prescription" or "Rx only" or "Solamente Rx" The route(s) of administration (if not to be taken orally) Special storage instructions I.e. temp, light, etc Manufacturer's control/lot number Manufacturer's expiration date (on immediate container & outer package) Bar code (but not if: sold directly to patients; Rx samples; allergenic extracts; OTC if packaged for hospital use) If OTC, then all of the above (except Rx only) plus adequate directions for use such that a consumer can use the product safely
DSCSA: Dispenser (pharmacist), trading partners: Notify if you have an illegitimate product
Notify FDA within 24 hours using Form 3911 Notify other trading partners within 24 hours Request notification termination using Form FDA 3911
Biologics Price Competition and Innovation Act of 2009
Part of Affordable Care Act Created abbreviated licensure pathway for biologics shown to be "biosimilar" - Public Health Service Act Like a generic (but NOT a generic) alternative for biological products ⇒ not exactly interchangeable
Dispenser must provide Medication Guide when product is dispensed [24 CFR 208.24(e)] EXCEPT:
Prescriber may (using clinical judgment) instruct dispenser to not provide medication guide BUT if patient asks for information, dispenser must provide medication guide despite prescriber instruction
DSCSA: Covered products
Prescription drug in finished dosage form for administration to a patient without further manufacturing (such as capsules, tablets, lyophilized products before reconstitution)
Manufacturer "Labeling" of Human Prescription Drugs [21 CFR 201.56 & 21 CFR 201.57]: Package Insert
Prescription drug labeling, prescribing information FDA must approve package insert (informational only) Applies to all drugs approved by NDA or BLA Primary purpose: To give healthcare professionals information needed for appropriate prescribing
Poison Prevention Packaging Act (PPPA)
Requires child-resistant packaging ("CRP") on oral doses of OTC and prescription drugs intended for household use, unless: If Rx only, Prescriber (for specific prescription) or patient (may be prescription-specific or "blanket waiver") requests non-CRP
FDA's REMS Programs [21 USC 355(p)]
Risk Evaluation and Mitigation Strategy (REMS) Designed to reduce risk/occurrence of serious adverse event FDA determines REMS is needed, and manufacturer must develop, implement and assess REMS program Usually needed where interventions beyond labeling are needed Most REMS include patient communication component, such as a Medication Guide, about specific safety risk(s) Some REMS include additional clinical activities or interventions, known as elements to assure safe use (ETASU).
DSCSA Requirements [21 USC] Track & trace requirements do not apply to:
Samples Veterinary drugs OTC drugs
National Drug Code (NDC) Numbers [21 USC 360]: The Drug Listing Act
The Drug Listing Act of 1972 requires registered drug establishments to provide FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution.
National Drug Code (NDC) Numbers [21 USC 360]: NDC Directory
The NDC Directory does not contain all listed drugs, only the final marketed drugs where information was submitted electronically to FDA. The NDC Directory also does not include animal drugs, blood products, or human drugs that are not in final marketed form, such as active pharmaceutical ingredients (APIs), drugs for further processing, drugs manufactured exclusively for a private label distributor, or drugs that are marketed solely as part of a kit or combination product or inner layer of a multi-level packaged product not marketed individually.
Which of the following statements about the NDC number are true
The NDC number may be used for reimbursement purposes
FDA Recall Authority [21 CFR Part 7, Subpart C]: Class 3
The drug product is unlikely to cause any adverse health consequences
Breakthrough Therapy
Treats a serious condition and there is evidence of meeting a clinically significant endpoint that shows advantage over existing therapy Requested by applicant, but FDA may suggest applicant consider making the request FDA acts on request within 60 days
Accelerated Approval
Uses surrogate or intermediate clinical endpoints (these do not establish actual clinical efficacy) to show therapy has promise of clinical benefit Approval of application subject to phase 4 confirmatory trials
FDA Recall Authority
Voluntary and initiated by the manufacturer/distributor It is the manufacturer's responsibility to send written notices to all wholesalers and pharmacies for recalls in Class I & II categories; some Class III recalls are handled with written notices
New Drug Application (NDA)
When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States. For internal tracking purposes, all NDA's are assigned an NDA number.
Recall Communications & Recipient's Responsibilities [CFR, FDA]: Recipient's Responsibility Class 1
Where there is a Class I recall of a prescription drug, the FDA expects retail, hospital and nursing home pharmacists to 1. review their records to identify all patients to whom the drug was dispensed 2. notify the patients' prescribers of the recall (prescriber will decide whether patients are to be contacted) STATE LAW CAN BE MORE STRICT
Biological Product means:
a virus therapeutic serum toxin or antitoxin vaccine blood, blood component or derivative allergenic product protein (>40 amino acids in size) or analogous product arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound) applicable to the prevention, treatment, or cure of a disease or condition of human beings.
Cosmetic means:
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 articles intended for use as a component of any such articles; But NOT soap.
"Pharmacy intern" (CT)
an individual registered under the provisions of section 20-598;
Recall Communications & Recipient's Responsibilities [CFR, FDA]: A recall communication should...
be brief and to the point clearly identify the product, size, lot number, code, serial number and any other pertinent descriptive information explain the reason for the recall and any hazard involved provide specific instructions on what should be done with the recalled product provide a way for the recipient of the recall communication to report whether it has any product
Medication Guides [21 CFR Part 208]: FDA requires that Medication Guides be issued if:
certain information is necessary to prevent serious adverse effects patient decision-making should be informed by information about a known serious side effect with a product, or patient adherence to directions for the use of a product are essential to its effectiveness
DSCSA: Pharmacist responsibilities summary
confirm entities you do business with are licensed or registered receive, store, and provide product tracing documentation investigate and properly handle suspect and illegitimate drugs
Recall Communications & Recipient's Responsibilities [CFR, FDA]: A recall communication should NOT...
contain irrelevant statements or promotional materials that detract from the message
"Wholesaler" Entities in Connecticut [CGS 20-571]: "Third-party logistics provider"
distributes drugs/devices/cosmetics by taking possession (but not title) usually integrates warehousing and shipping functions ("pick and pack") on contract with manufacturer and integrated with the manufacturer's systems (does not "own" the product)
Labeling of Drugs Dispensed on Prescription [21 USC 353(b)(2); CGS 21a-109; RCSA 20-576-25]: Prescription Labels Requirements
drug is dispensed "on a written or oral prescription" of an authorized prescriber & the drug's label contains: Dispenser's name and business address Serial number Date of fill/refill Prescriber's name Patient's name Directions for use Required cautionary statements
Recall Communications & Recipient's Responsibilities [CFR, FDA]: Recipient's Responsibility General
immediately carry out the instructions in the recall communication
DSCSA: Transactions excludes
intracompany distributions distribution amoung hospitals under common control public health emergencies dispensed pursuant to a prescription product sample distribution blood and blood components for transfusion min quantities by a licensed pharmacy to a licensed practitioner certain activities pursuant to a merger or sale certain combination products certain medical kits certain IV products Medical gas distribution Approved animal drugs
Drug Wholesalers and Manufacturers [CGS 21a-70]: Manufacturer
is an entity that prepares, synthesizes, compounds, packages, repackages, or labels under a trademark any drug, device, or cosmetic Or is a sterile compounding pharmacy that dispenses CSPs without a prescription or patient-specific order
Registration of Manufacturers and Wholesalers Exception
manufacturer that is not in Connecticut -- but is registered with FDA -- need only file copy of FDA registration with DCP to operate (sterile compounding pharmacies are NOT included in this exception)
"Prescription" (CT)
means a lawful order of a prescribing practitioner transmitted either orally, in writing or by electronic means for a drug or device for a specific patient.
"Prescribing practitioner" (CT)
means an individual licensed by the state of Connecticut, any other state of the United States, the District of Columbia, the Commonwealth of Puerto Rico or any territory or insular possession subject to the jurisdiction of the United States who is authorized to issue a prescription within the scope of the individual's practice;
"Pharmacist" (CT)
means an individual who is licensed to practice pharmacy under the provisions of section 20-590, 20- 591, 20-592 or 20-593, and who is thereby recognized as a health care provider by the state of Connecticut;
"Pharmacy technician" (CT)
means an individual who is registered with the department and qualified in accordance with section 20-598a;
"Administer" or "Administration" (CT)
means the direct application of a drug or device to the body of a patient or research subject by injection, inhalation, ingestion or any other means.
"Substitute" (CT)
means to dispense without the prescribing practitioner's express authorization a different drug product than the drug product prescribed
"Practice of pharmacy" (CT)
or "to practice pharmacy" means the sum total of knowledge, understanding, judgments, procedures, securities, controls and ethics used by a pharmacist to assure optimal safety and accuracy in the distributing, dispensing and use of drugs and devices;
"Wholesaler" Entities in Connecticut [CGS 20-571]: "Virtual manufacturer"
owns NDA or ANDA (if drug) or unique device ID number (if Rx device) contracts with manufacturing organization for physical manufacture of drug/device/cosmetic is not involved with physical manufacture of product does not take possession of, or store, product
prescription drug & biological product labeling: M & F of reproductive potential
subsection labeling must include: Relevant information on pregnancy testing/contraception, and if required/recommended before, during, after use Any human or animal data that suggests drug-associated fertility effects
prescription drug & biological product labeling: pregnancy
subsection labeling must include: Summary of risks of all relevant data sources (or statement that drug is not absorbed systemically) If "pregnancy exposure registry" exists, statement of such existence with contact information on how to enroll
prescription drug & biological product labeling: lactation
subsection labeling must include: Summary of risks of all relevant data sources (or statement that drug is not absorbed systemically) Relevant ways to minimize drug exposure when breast feeding, and available interventions for monitoring/mitigating adverse reactions
A Drug is Adulterated if...[21 USC 351; CGS 21a-105]
think composition It contains any filthy, putrid or decomposed substance It has been produced, prepared, packed, or held under insanitary conditions where it may have been contaminated or made injurious to health It was made by a method or in a facility that does not meet cGMP to assure that drug meets the applicable safety, identity, strength, quality, and purity standards (or, if it is a compounded PET drug, it does not conform to PET compounding standards and official monographs in the USP) Its container is composed of any poisonous or deleterious substance that may render the contents injurious to health It contains an unapproved or unsafe color additive It is recognized in an official compendium (USP-NF, HPUS), but does not conform to the standard's strength, quality or purity If it is not recognized in an official compendium and its strength, purity or quality is not what it purports to be Its active ingredient is substituted -- or its strength or purity decreased by mixing - with another substance It is an OTC drug that is not packaged in a tamper-resistant container