Law need to know

Who must register with FDA

Manufactures, repackages, outsourcing facilities large scale compounders

Responsibility of SAMHSA

regulates opiod treatment programs (methadone). creat resources (locations, helpline, tips), regulates confidential information about suds records

What law makes it so FDA approves for efficiency

Kefauver-Harris Amendment

what law makes it so FDA approves for safety

federal food drug cosmetic act

what law made the split of rx vs otc

Durham-humphrey amendment

what law created the idea of adultered vs misbranded

pure food and drug act

Three T’s of track and trace documents

transition history, statements, informations. (SHIT)

how long to maintain track and trace records

6 years

exemption for track and trace

dispensing to patient, product return, sale for one pharmacy to another for a specific Rx, minibus, office use dispersal, samples, intracompany dispersal

what form and timeline for a suspect illegiatment product received

24 hours for FDA FORM 3911 and contacting trading partners

Expections to OTC TAMPER PROOF

except derm, dentifrice, insulin or lozenge

What is required on OTC Label

Active ingredient (+ dosage form); uses; directions for use; warnings; if it includes Na+, Ca+, Mg+, K+, phenylalanine, aspartame; storage information; inactive ingredients; questions (telephone number) FDA medwatch statement if not toll free number; the established name; name and address of manufacturer/packer/distributor; quantity of drug; expiration date; lot number.

When is Patient Package Insert required to be given?

For oral contraceptives and estrogen-containing products at every dispensing. Acute-care hospitals/long-term care facilities must provide at the first dose and every 30 days thereafter

What can a supplement claim

a benefit related to a classical nutrient deficiency, affect the structure or functions in humans, characterize the documented mechanism, describe general well-being from consumptions. But must alos state that it was not evelauted by FDA

Do supplements have to follow cGMP?

Yes

What are exceptions to general prohibition on drug importation

Personal (limited to 90 supply)

Section 804: allows for states/tribe to develop a program to import certain drugs from Canada (excludes controls, IV, biologics, REMS drugs). Must be relabeled with the required US labeling

Manufacturers who make an FDA-approved drug outside of the US who were originally intending to sell that drug in that foreign country (MMA products)

How long must controlled substance prescription be keep for record keeping

2 years

How long must a Medicare part D prescription be kept?

10 years

DEA statemnet on making corrections to a controlled substance prescription

may make changes to a prescription after oral consultation with the prescriber

What goes on a prescription label?

name and address of pharmacy, NDC, date of Rx/filled, name of prescriber, name of patient (if on Rx), directions, cautionary statements, expiration date

Biosimilar vs. interchangeable biologic

Interchangeable is just an extra step in the Purple book to show it can be used

When does a pharmacy have to abide by the poison prevention packaging act. Exceptions?

oral medications unless patient/prescriber makes the request; sublingual nitro; sublingual/chew isosorbide dinitrate; hospitalized patients; specific dosing on packaging (methylpred dose pack/contraceptions). Documentation not required. The prescriber must ask per script.

What is the point of OBRA90

proivded the pharmacy with practice standards for dispenings covered outpatient prescription for Medicaid patients

Obra 90 requires pharmacies to __

conduct prospective DUR before filling medication; counseling patients; and keeping a up to date patient profile. DO not have to document counseling

Can you chart order non-control substances in LTCF? how about controls

yes. No

How often does DEA registration need to be renewed? What form?

Manufactuers and distributors anually. Pharmacies and practitioners every 3 years. NO eariler than 60 days from expiration date, DEA 223

DEA Form 41?

Disposal or destruction of controlled substances

DEA form 106

Thefot or loss

DEA Form 222?

Ordering C-II’s

DEA Form 224? 224a? 224b?

224 = dispenser registration. 224a renewal registration. 224b chain pharmacy renewal

DEA Form 363

Methadone for addiction

DEA Form 510

Whole distribution of scheduled listed chemical products (psuedo)

How to verify DEA number

first letter is there profession, 2nd letter typically first letter of last name.

add 1st, 3rd, 5 digits together. Then add 2nd, 4th, 6th and times 2. add together. last digits sshould match

Who can fill a script for a control substance?

Pharmacist?

How long to get written prescription after emergency C-II?

7 days. if not recevied pharmacy contacts local DEA

Can you fax a C-II prescription?

NO, not a valid script unless

schedule II narco for direct parenteral admin, Schedule II substance for LTCF, narcotic for hospice patient

How long is a C-II script valid after the pharmacy partial due to being out of stock

72 hours to fill remainder.

How long is a C-II script valid after the patient request a partial fill

30 days

How long is a C-II script valid after the prescriber request a partial fill

30 days

How long is a C-II script valid if partial and the patient is terminally ill

60 days

How long is a C-II script valid if partial and the patient is in LTCF

60 days

How long are CIII prescription valid for

6 months

How long are CIV prescription valid for

6 moths

How long are CII prescription valid for

undefend federally

How long are CV prescription valid for

undefined federally

Can written tramdol prescription for a Medicare part D patient be filled by pharmacy?

Controlled substance prescriptions for patients with Mediare Part D or advanage must be precribed electronically so no. But many exceptions apply so typically still can

Can you use a computer system and amanual system to keep track of refills on scripts?

NOPE 🙂 if script is electronic then it must stay electronic and you can’t have both so just make it all electronic

How long to sign hard copy printout of each day’s controlled substane prescritpion orde refill data?

72 hours

How long to sign a statement verifying the controlled prescription that the pharmacist refilled for those without a printout

by the end of the day

max time to recevie a refill audit trail from central pharmacy?

48 hours

Who is needed to grant someone POA for DEA 222 form

the registrant, he person being granted POA, and 2 witnesses

Who is needed to revoke POA

the person who signed the most recent application for DEA registation 223, and 2 witnesses

Storage of DEA 222

Executed 222 forms must be maintained separately from all other records and kept for at least 2 years at registered location.

record keeping of C-III, IV, V ordering

must keep a receipt (invoice or packing slip) of drugs recevied. keep for 2 years. for Controls may be kept at central location

What control info can be kept at central location. How long to retreive

Shipping and financial records with lack of denial after 14 days of request. 2 business days to reteive at DEA request. Executed order forms, prescriptions, and inventiory records can not be kept at central locations.

True false, all C-II records and inventories must be maintained separetely from all other pharmacy records

true. Three file vs two files (Red C on Ciii-V)

When should DEA be notified about theft or loss? What form?

When there is any theft or “significant loss” of any controlled substance, DEA must be notifed in writing within one business day. DEA 106 within 45 calendar days (unless miscount or clerical error, then no form needed)

What if excessive loss of psyedoephdrine, how to contact and document? what form and how long?

call local DEA office as soon as possible and DEA form 107 within 15 days of discovery

When are exact counts needed for inventory recordkeeping of controls?

C-II exact. C-III-V estiamate if container is open unless container holds more than 1000 units

How often for controlled substance inventory?

every 2 years, newly scheduled drugs

When does the 5% of dispening control come about?

A pharmacy can not exceed 5% of total number of dosage units of controlled substance distrubted to pracitoner. If so they are considered a distrubutor (and dispner)

Rules for sale of OTC C-V

Must be sold by pharmacist, confirm for legit purpose, no more than 240 mL/48 dosage units of opium. 120 mL or 24 dosage unit of any other control. Can have purchased the same thing within 48 hours. purhases is at least 18 and show ID

What is required in record book for sale of OTC C-V sale

name and address of purchaser, name and quantity of controlled substance purchased, date of purchase, name/ss of pharmacist

Can a hospital dispense methadone? Can a community pharmacy

Hospital: Yes for pain, yes for continuing therapy.

Community pharmacy: yes for pain; NEVER for OUD

What are exceptions for dispening opiods for OUD

A prescriber may dispense from their inventory (not prescribe) narcotic drugs for a maximum 3 day supply for the purpose of initiating maintenance treatment or detoxification treatment. Or continunig therapy for hospitalized patient incidental to treating a condition other than addication

Max psuedophed in 1 day, 30 days, 30 days mail

3.6 g/ day, 9 g/30 days. 7.5 grams/30 days by mail order.

When is psuedophed logbook recording not neeeded? How long to keep log book

Not requred log book for less than 60 mg.

2 years

Seller have to get self-certifcation and trained every ____

year

What is required to dispense. acontroled substance by means of the internet

modication of DEA 223. must notifey DEA within 30 days of starting to dispense

When do internet pharmacy have t oreport to DEA. How often?

if 100 or > Rx, filled, 5,000 or > dosage units, or if they don’t meet these thresholds send a negative. Monthly on the 15th of each month. These counts include walk in business not just internet

Prescription for controlled substane must included ____

Date, full name and address of patient, drug name/strength/dosage form/quantity/directions, refills (if any), full name and address of prescriber, DEA #, signature.

Label requirement for controlled substance

date, pharmacy name and address, Rx #, name of the patient, name of the prescribing practitioner, directions for use, cautionary statements