Texas MPJE, Ultimate Texas MPJE
[Document subtitle]
[DATE]
[COMPANY NAME]
[Company address]
,Texas pharmacist can administer all vaccines True
What age can pharmacist administer influenza 7
What is the min age for all other vaccines 14
How many hours for nuclear training 700 hours
State board is made up of how many members 11
How many pharmacists are on the state board 7
How many techs are on the state board 1
How many public members are on the state board? 3
What are pharmacists requirements to be on the board? resident of texas,
actively practicing pharmacy, been licensed for 5 years prior to appointment
How long do board members serve 6 years
Special CE requirements Texas pharmacy laws or rules 1 hr
Pain management 1 hr
Prescribing and monitoring controlled substances 2 hrs
Mental health awareness 1 hr
Preceptor CE if certified preceptor
When does license renew every 2 years from birth month
Food Drug and Cosmetic Act Established FDA and required new drugs to be
proven safe prior to marketing
Durham-Humphrey Act of 1951 Established Rx and OTC drug class;
authorized verbal prescriptions and prescription refills
Kefauver-Harris Amendment Required new drugs to be proven safe and
effective, established GMPs, FDA jurisdiction over prescription drug advertising
Prescription drug market act Bans reimportation of prescription drugs and
insulin products produced in the US except by manufacturer. Bans sale, trade
or purchase of samples
Drug Quality and Security Act Allows facilities that are compounding sterile
that are not patient specific to register as outsourcing facility
Outsourcing facilities have a licensed pharmacist, report to secretary of HHS
every 6 months, be inspected by FDA, report serious ADR within 15 days , label as
compounded drug
Drug Supply Chain Security Act Requirements for tracing prescription drug
products through pharmaceutical supply distribution chain. Transaction data
, Adulteration contains filthy, putrid, or decomposed substance, prepared or held
in unsanitary conditions, manufacturing methods dont conform to GMP, container
is composed of poisonous substance, has unsafe color additive, different strength,
mixed or packed with substance that reduces strength and quality
Misbranding Labeling of a product that is false or misleading; label
information must include directions for use; safe and/or unsafe dosages;
manufacturer, packer, or distributor; quantity; and weight, Rx only, route of admin,
special storage instructions, Lot number, expiration, package insert
Only pharmacies allowed to work with drug samples Pharmacy owned
by charitable organization or government serving indigent population;
Class D Three constituents of data required to be provided by
manufacturer for each product sold Transaction
information, history, and statement
Transaction Information constituents Drug name strength dose and NDC,
container size and count, transaction date, name and address of seller and buyer
Transaction history Prior transaction information for each prior transaction
Transaction Statement States seller is authorized for transaction,
information and history were provided and are correct, and product is
legitimate and has processes to comply with verification requirements, previous
seller was legitimate and provided true information
Exceptions to distributing without a license Distributing between common
ownership, patient specific basis, emergency medical reasons, or minimal
quantities to a practitioner for office use
Adulteration Actual contents of product is below standard or is unsafe.
Misbranding Labeling that is misleading or missing required information,
non- compliant with PPA
Requirements for manufacturer's label of prescription drugs Manufacturer name
and address, drug name, dose quantity, route for non-PO, lot, and expiration,
package insert, storage instructions, Rx only legend
Requirements for OTC drug labels Principal display panel, including statement
of identity of product
Manufacturer name and address
Net qty of contents
Cautions and Warnings
Adequate *directions* for use
"Drug Facts" panel: active ingredients, purpose, indication, warning, directions, other
info, inactive ingredients, questions followed by phone #
Special warning requirement ingredients Yellow #5/6, aspartame,
sulfites, mineral oil, wintergreen oil, sodium phosphates (90 mL max),
[Document subtitle]
[DATE]
[COMPANY NAME]
[Company address]
,Texas pharmacist can administer all vaccines True
What age can pharmacist administer influenza 7
What is the min age for all other vaccines 14
How many hours for nuclear training 700 hours
State board is made up of how many members 11
How many pharmacists are on the state board 7
How many techs are on the state board 1
How many public members are on the state board? 3
What are pharmacists requirements to be on the board? resident of texas,
actively practicing pharmacy, been licensed for 5 years prior to appointment
How long do board members serve 6 years
Special CE requirements Texas pharmacy laws or rules 1 hr
Pain management 1 hr
Prescribing and monitoring controlled substances 2 hrs
Mental health awareness 1 hr
Preceptor CE if certified preceptor
When does license renew every 2 years from birth month
Food Drug and Cosmetic Act Established FDA and required new drugs to be
proven safe prior to marketing
Durham-Humphrey Act of 1951 Established Rx and OTC drug class;
authorized verbal prescriptions and prescription refills
Kefauver-Harris Amendment Required new drugs to be proven safe and
effective, established GMPs, FDA jurisdiction over prescription drug advertising
Prescription drug market act Bans reimportation of prescription drugs and
insulin products produced in the US except by manufacturer. Bans sale, trade
or purchase of samples
Drug Quality and Security Act Allows facilities that are compounding sterile
that are not patient specific to register as outsourcing facility
Outsourcing facilities have a licensed pharmacist, report to secretary of HHS
every 6 months, be inspected by FDA, report serious ADR within 15 days , label as
compounded drug
Drug Supply Chain Security Act Requirements for tracing prescription drug
products through pharmaceutical supply distribution chain. Transaction data
, Adulteration contains filthy, putrid, or decomposed substance, prepared or held
in unsanitary conditions, manufacturing methods dont conform to GMP, container
is composed of poisonous substance, has unsafe color additive, different strength,
mixed or packed with substance that reduces strength and quality
Misbranding Labeling of a product that is false or misleading; label
information must include directions for use; safe and/or unsafe dosages;
manufacturer, packer, or distributor; quantity; and weight, Rx only, route of admin,
special storage instructions, Lot number, expiration, package insert
Only pharmacies allowed to work with drug samples Pharmacy owned
by charitable organization or government serving indigent population;
Class D Three constituents of data required to be provided by
manufacturer for each product sold Transaction
information, history, and statement
Transaction Information constituents Drug name strength dose and NDC,
container size and count, transaction date, name and address of seller and buyer
Transaction history Prior transaction information for each prior transaction
Transaction Statement States seller is authorized for transaction,
information and history were provided and are correct, and product is
legitimate and has processes to comply with verification requirements, previous
seller was legitimate and provided true information
Exceptions to distributing without a license Distributing between common
ownership, patient specific basis, emergency medical reasons, or minimal
quantities to a practitioner for office use
Adulteration Actual contents of product is below standard or is unsafe.
Misbranding Labeling that is misleading or missing required information,
non- compliant with PPA
Requirements for manufacturer's label of prescription drugs Manufacturer name
and address, drug name, dose quantity, route for non-PO, lot, and expiration,
package insert, storage instructions, Rx only legend
Requirements for OTC drug labels Principal display panel, including statement
of identity of product
Manufacturer name and address
Net qty of contents
Cautions and Warnings
Adequate *directions* for use
"Drug Facts" panel: active ingredients, purpose, indication, warning, directions, other
info, inactive ingredients, questions followed by phone #
Special warning requirement ingredients Yellow #5/6, aspartame,
sulfites, mineral oil, wintergreen oil, sodium phosphates (90 mL max),
