Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Monday, September 1, 2014
Inventory Requirements When a Drug is Scheduled in Kansas
Inventory Requirements When a Drug Is
Scheduled
Tramadol became a federally controlled Schedule IV drug beginning
August 18, 2014. Pursuant to 21 CFR §1304.11, a pharmacy
is required to take an inventory of any CS that is added to the list
on the effective date of the rule. Thereafter, the substance needs
to be included in each inventory made by the registrant.
Kansas requires an annual inventory of CS. Each inventory of
Schedule II CS and all products containing hydrocodone require
an exact count. Make sure you designate on the inventory whether
it was taken at the beginning or close of business.
The Kansas State Board of Pharmacy has taken steps to have
tramadol removed from the Kansas Tracking and Reporting of
Controlled Substances (K-TRACS) drugs of concern regulation.
Tramadol will need to be reported to K-TRACS now that it has
been federally scheduled.
source found here
Multiple Prescriptions of a Schedule II CS in Kansas
Multiple Prescriptions of a Schedule II CS
The federal rule allows a practitioner to provide a patient with
multiple prescriptions on the same day for the same Schedule II
controlled substance (CS) to be filled sequentially. There is no
federal or state limit on the amount a prescriber can prescribe, but
when a prescriber issues multiple prescriptions of the same drug
on the same day, the combined amount shall not exceed a 90-day
supply. It is up to the prescriber to determine how many separate
prescriptions to write. For example, a prescriber may issue three
30-day Schedule II prescriptions to cover the 90 days, or he or she
may issue nine 10-day Schedule II prescriptions to cover the 90
days. Each prescription must be individually written on a separate
prescription. Once the prescription is filled, the inspector would
expect to find either three separate canceled prescriptions or nine
canceled prescriptions.
Source found here
APHA: Two years after meningitis outbreak, Massachusetts passes compounding overhaul
Pharmacists who compound preparations within the Commonwealth of Massachusetts and those who ship compounded preparations into the state from elsewhere must adhere to new regulations starting this December. Gov. Deval Patrick of Massachusetts signed HB 4235, which effectively overhauls the regulation of pharmaceutical compounding in the state, on July 10. Sections of the law take effect in December. The entire law takes effect June 30, 2015.
continue to read here
continue to read here
Sunday, August 31, 2014
More Very Imformative Comments from Readers!
What is characterized as "greed" here is a good first step, but, it refers to only a stratum of greed layered on top of the baseline enrichment--what are already very high profit margins that can be obtained from mixing drugs from scratch from chemicals that may have no warranties on their certificates' stated attributes--a reality that probably has not been disclosed to parties involved in compounded drug transactions, including payers. It may not be characterized as "greed" if you only mark-up for the pharmacy--but is it is okay to expose patients to untested drugs if you keep the margins under the radar? Does it become greed only when you mark-up in a manner that trips the payer alarms, after building in added profits for the pharmacy, the doctors, the business partners, etc? Then the non-FDA approved drugs stand out like neon on a black and white photocopy. The recent case highlighting creams sold for thousands revealed that the pharmacy was charging less than 100.00. If on Finally a Compounder Says It: Greed Is Not Good!!
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Anonymous
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at 5:00 PM
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If you look across the industry over decades, you will notice the “would-be” NDA/ANDA/BLA holders’ organized market entry campaigns that pop-up simultaneously across the nation—bioidentical hormones, chelation therapy, nicotine lollipops, topical pain creams take I (local anesthetics) and topical pain creams take II (centrally acting agents). These national “launches” have taken on new meaning after the Supreme Court decision, with pharmacies nudged by the “would-be” NDA/ANDA/BLA and patent holders to hire individual or shared sales forces to “detail” specific products to any willing doctor, or medical practice, or hospital, or alternative care setting. It is a truly brilliant model for escaping and/or circumventing public health oversight—spread the manufacturing across 10,000 pharmacies, and, separated into so many pieces it has very little chance of raising regulatory scrutiny, by FDA, states, or other. And if people are being harmed in small numbers here and there from on Compounding Group Taps Former Express Scripts Official
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Anonymous
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at 11:36 AM
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The sooner payers (and pharmacists and doctors) recognize that they are the "pass throughs" in a vastly decentralized, sub-standard drug industry, the better. The "would be" NDA/ANDA holders are the entities filing patents, selling chemicals and formulas, and marketing and promotional materials, without warranty, escaping layers and layers of legal and regulatory scrutiny under the imprimatur of the practice of medicine and pharmacy. File a patent, write a recipe, source the chemicals, call in the marketers, drop it into 10,000 pharmacies or doctors' offices nationwide and "game-on." on Compounding Group Taps Former Express Scripts Official
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Anonymous
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at 10:28 AM
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I could not access the entire article, but, if you look at historical warning letters over time, you will see the FDA has used the same enforcement options prior to 1997 FDAMA, and under Section 503A, and under Section 503A in regions where it held with advertising restrictions severed after the SC ruling, and where 503A was not in force post SC ruling, under prior guidance. The new law resolves ambiguity--nothing new with respect to enforcement options? on FDA Releases Slew of Warnings to Compounding Pharmacies
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