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58 Cards in this Set
- Front
- Back
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Pure Food and Drug Act of 1906
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Prohibited adulterated and misbranded foods or drugs from interstate commerce, however
originally did not consider false misleading efficacy claims as misbranding (could claim a bottle of water could cure cancer) Misbranding only applied to strength, quality and purity or drug Identification of ingredients, directions and warning was not required |
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Pure Food and Drug Act of 1906
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Amended in 1912 to prohibit false and fraudulent claims, but fraudulent intent was required and this was difficult to prove - this legislation needed work
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Food Drug and Cosmetic Act of 1938
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Precipitated by sulfanilamide disaster
Untested diethlyene glycol chosen as solvent --> 107 deaths FDA didn't have the authority to pull the elixir form the market, but relied on the misbranding provision |
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Food Drug and Cosmetic Act of 1938
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No new drug could be marketed unless proven safe for use under conditions described on the label and needed to be approved by the FDA
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Durham Humphrey Amendment of 1951
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Enacted to better serve the FD and C Act requirement for adequate directions for use on the label since many drugs were not safe w/o medical supervision
Created 2 classes of drugs - Rx and OTC Authorized oral prescriptions and refills of prescriptions |
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Kefauver Harris Amendments
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Triggered by Thalidomide disaster
Required that drugs be proven not only safe but effective as well Made retroactive to the drugs marketed between 1938 and 1962 |
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Medical Device Amendments of 1976
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Improved FDAs regulatory authority over medical devices intended for human use
Classification of devices according to their function Required Pre-market approval Establishment of performance standards |
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Orphan Drug Act
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Tax incentives and exclusive incentives to develop market drugs for rare diseases (affects less than 200k people in US)
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Waxman-Hatch Amendment
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Provides accelerated approval process for genertics
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Prescription Drug Marketing Act
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Establishes sales restrictions and record-keeping requirements for drug samples
Prevents the resale of drugs purchased by hospitals and other non-profit entities Requires that drug wholesalers be licensed |
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Dietary Supplement Health and Education Act (DSHEA)
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Defined dietary supplements as a product intended to supplement the diet and containing any one or more of the following: Vitamin, mineral, herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; concentrate, metabolite, constituent, extract or combination of above
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DSHEA
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Not allowed to make claims that the product is intended to diagnose, cure, mitigate, or prevent a disease
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DSHEA
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4 Types of statements are allowed: 1) Statements that the product will benefit a classical nutrient deficiency disease, 2) Statements that describe the role of the dietary supplement in affecting the structure or function of the body, 3) Statement that characterize the documented mechanism by which a nutrient acts to maintain structure/function 4) Statements describing the general well-being from consumption of a nutrient
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Additional Requirements
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The label of the product must state: 1) This statement has not been evaluated by the FDA, 2) This product is not intended to diagnose, treat, cure or prevent any disease,
Manufacturer must notify the FDA within 30 days if it makes one of the permitted statements |
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United States Pharmacopeia Convention
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Establish standards for drug potency, quality and composition
Independent of FDA, although FDA is involved in the development and the modification of drug monographs Any drug listed must meet all |
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Previous to the Durham Humphrey Amendment, the manufacturer decided Rx vs OTC.
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If the FDA challenged an OTC status, it had to prove 2 things: That the pharmacologic and toxic effect could harm the patient unless taken under the physicians directions and that the patient will suffer harm if he/she relies on a drug that can't cure condition and postpones the visit to the doctor
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Rx label requirements
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Name, address, telephone and DEA number of the pharmacy
Name of the patient Full directions for use Name of prescriber Serial number of the prescription and date originally filled Trade or brand name of drug, strength, dosage form, quantity dispensed. Controlled substances: caution federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed NOT initials or name of person who filled the prescription or refills |
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Beyond Use Date Guidelines
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For multiple unit containers - BUD not later than the expiration date on the manufacturer's container of one year from the date the drug is dispensed, whichever is earlier
USP guidelines not entirely adopted in PA, does not require this |
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Switch of Rx to OTC
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Manufacturer can submit a supplemental NDA requesting it
Manufacturer can petition the FDA The drug can be switched through the OTC drug DESI review process One manufacturers drug may be OTC while another manufacturers same drug may be Rx |
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Plan B
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Must be 17 to purchase
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Prescription Refill Authorization
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Physician cannot delegate prescriptive authority to an agent
Agent can transmit refill authorization to the pharmacist or even write out a Rx as long as the doctor signs it |
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Prescriptive Authority
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Determined by states - Important to know scope (in PA)
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CRNP
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Cannot prescribe Gold compounds, heavy metal antagonists, radioactive agents and oxytocics
May prescribe Schedule II substances for up to 30 days Schedule III-IV substances for up to 90 days |
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CRNP Rx Blank
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Cert number of the CRNP
Printed name of CRNP Signature of CRNP DEA number Collaborating physician's name not required |
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PA
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Negative formulary eliminated in November 2006
Physician can delegate prescribing dispensing and administration of drugs and devices if the drug or device if permitted under the written agreement |
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Prescription Refill Authorization
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Physician cannot delegate prescriptive authority to an agent
Agent can transmit refill authorization to the pharmacist or even write out a Rx as long as the doctor signs it |
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Prescriptive Authority
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Determined by states - Important to know scope (in PA)
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CRNP
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Cannot prescribe Gold compounds, heavy metal antagonists, radioactive agents and oxytocics
May prescribe Schedule II substances for up to 30 days Schedule III-IV substances for up to 90 days |
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CRNP Rx Blank
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Cert number of the CRNP
Printed name of CRNP Signature of CRNP DEA number Collaborating physician's name not required |
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PA
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Negative formulary eliminated in November 2006
Physician can delegate prescribing dispensing and administration of drugs and devices if the drug or device if permitted under the written agreement |
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PA Prescription Blanks
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Same as for CRNP, but supervising physicians name required, not signature however
Permitted to prescribe Schedule II substances 72 hours supply for initial therapy and 30 days supply for ongoing therapy Schedule III-V substances for up to 30 day supply and authorize up to 5 refills within a 6 month period |
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Optometrist
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T in license - Can prescribe (mostly topical and some orals)
G - Glaucoma certified L - Not certified to prescribe at all Topical: Many agents Oral: Steroids, antibacterial agents, analgesics |
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Optometrist
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Treatment initiated may not continue beyond 6 weeks unless documented consultation with a licensed physician
Therapy certified optometrists CANNOT prescribe parenterals, beta blockers, drugs for systemic conditions, drugs for glaucoma |
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Optometrist
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Glaucoma prescribed may prescribe
Beta blockers Cholinergic receptor agonists Adrenergic receptor agonists Topical carbonic anhydrase inhibitors Prostaglandin analogs |
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Optometrist
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Not permitted to prescribe Schedule II
Permitted to prescribe Schedule III-V |
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Certified Nurse Midwife
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Recently granted prescriptive authority
Can only prescribe pschotropic drugs after consultation with physician Prescription blank the same as PA but with phone number required |
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CNM
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Permitted to prescribe CII to CIV
Controlled substances can only be prescribed to treat acute pain CII limited to 72 hours CIII - CIV limited to 30 days |
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Patient Package insert Required
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Oral and Injectable Contraceptives
Estrogen-containing drugs Intrauterine contraceptive devices |
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Medication Guides Required
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Could help prevent serious adverse effects
Risk information could affect decision to use or continue to use Patient adherence to directions Manufacturer must obtain FDA approval Provide sufficient number of the guides Required for almost 300 product ***This has been a source of contention as the FDA adds more things that need to be given to the patient*** |
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Unlabeled Indications
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Drug approval process lags behind the discovery of new uses for drugs
FDA: A prescriber may prescribe an approved drug for an unapproved use, or in a dosage not recommended by the labeling and the pharmacist may dispense such a prescription without violating Federal Law Manufacturers may recognize that the approval process is faster if fewer indications are listed on the original NDA |
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Unlabeled Indications
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3rd party insurers may refuse to pay for unlabeled use.
As the significance of the departure from the conventional use decreases, so does the therapeutic and legal risk Contact the doctor and do research when confronted with this. |
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Prescription Compounding
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FDAMA attempted to clarify manufacturered products from compounded products by exempting compounded products from GMP, Labeling, and NDA requirements
FDAMA restricted soliciting or advertising the compounding of any particular drug. This was deemed unconstitutional and was upheld by the Supreme Court. |
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Prescription Compounding
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FDA will defer to state authorities regarding less significant violations related to compounding
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Compounding Restrictions
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Compounding in anticipation of receiving prescriptions, except in very limited quantity
Compounding drugs withdrawn or removed from the market for safety reasons Compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot has been made in an FDA-registered facility |
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Unlabeled Indications
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3rd party insurers may refuse to pay for unlabeled use.
As the significance of the departure from the conventional use decreases, so does the therapeutic and legal risk Contact the doctor and do research when confronted with this. |
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Compounding Restrictions
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Receiving, storing or using drug components not guaranteed or otherwise determined to meet official compendial requirements
More.... |
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Prescription Compounding
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FDAMA attempted to clarify manufacturered products from compounded products by exempting compounded products from GMP, Labeling, and NDA requirements
FDAMA restricted soliciting or advertising the compounding of any particular drug. This was deemed unconstitutional and was upheld by the Supreme Court. |
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Prescription Compounding
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FDA will defer to state authorities regarding less significant violations related to compounding
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Compounding Restrictions
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Compounding in anticipation of receiving prescriptions, except in very limited quantity
Compounding drugs withdrawn or removed from the market for safety reasons Compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot has been made in an FDA-registered facility |
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Compounding Restrictions
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Receiving, storing or using drug components not guaranteed or otherwise determined to meet official compendial requirements
More.... |
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Unlabeled Indications
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3rd party insurers may refuse to pay for unlabeled use.
As the significance of the departure from the conventional use decreases, so does the therapeutic and legal risk Contact the doctor and do research when confronted with this. |
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Prescription Compounding
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FDAMA attempted to clarify manufacturered products from compounded products by exempting compounded products from GMP, Labeling, and NDA requirements
FDAMA restricted soliciting or advertising the compounding of any particular drug. This was deemed unconstitutional and was upheld by the Supreme Court. |
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Prescription Compounding
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FDA will defer to state authorities regarding less significant violations related to compounding
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Compounding Restrictions
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Compounding in anticipation of receiving prescriptions, except in very limited quantity
Compounding drugs withdrawn or removed from the market for safety reasons Compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs Receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot has been made in an FDA-registered facility |
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Compounding Restrictions
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Receiving, storing or using drug components not guaranteed or otherwise determined to meet official compendial requirements
More.... |
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Prescription Drug Marketing Act
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Prompted by concerns that many drugs used by consumers were adulterated and misbranded bc they did not come from normal distribution channels
Sale, purchase, or trade of samples is prohibited Counterfeiting of drug coupons is prohibited Practitioners must request samples in writing each time PDMA mandates storage, handling, and record-keeping requirements for samples. |
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PDMA
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Prohibits sale of drugs from hospitals EXCEPT:
1) Hospital purchases from a group purchasing organization or another member hospital 2) Sales or purchases to/from non-profit affiliates, or between hospitals or health care entities under common control 3) Emergency sales to community pharmacies to alleviate temporary shortage 4) Selling or dispensing prescription pursuant to prescription |
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Do not have to know
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Penalties for Violations of PDMA
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