| 12/21/2017 | Continental Manufacturing Chemist, Inc. | Detroit District Office | CGMP/Drug Products/Adulterated | Not Issued |
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
Wednesday, January 10, 2018
Friday, January 5, 2018
- Compounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. Posted 01/02/2018
| 01/03/2018 | AuroMedics Pharma LLC | Ampicillin and Sulbactam for Injection USP | Presence of glass particles | AuroMedics Pharma LLC |
Must Read! Compounding experts do not expect FDA to let up on the gas in 2018 on implementing the Drug Quality and Security Act,
Stakeholders Expect Flurry Of Compounding Action, Hope For ...
Inside Health Policy-8 hours ago
Compounding experts do not expect FDA to let up on the gas in 2018 on implementing the Drug Quality and Security Act, but many experts hope the agency will rethink what some see as its initial missteps in implementing the compounding law, including a perceived overly lax bar for compounding bulk substances and ...
| FDA aims to strengthen oversight of compounded drug manufacturing
The Food and Drug Administration aims to "reinvigorate" efforts to improve production standards for compounded drug products, highlighting continued safety concerns with the industry practice in a recent update published in the New England Journal of Medicine. Since a deadly meningitis outbreak in .
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IACP announced that TherapeuticsMD will no longer be an IACP corporate member.
| International Academy of Compounding Pharmacists Announcement
HOUSTON, Jan. 5, 2018 /PRNewswire/ -- The International Academy of Compounding Pharmacists (IACP), representing nearly 4,000 pharmacists, technicians, students and members of the compounding community who focus upon the specialty practice of pharmacy compounding, today announced
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Thursday, January 4, 2018
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Ogletree, Deakins, Nash, Smoak & Stewart
2017 has been quite a year, with ever-changing regulations, trends, and employee expectations at the local, state, and federal levels. In this environment of constant flux, an outdated ...
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell
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What Will Happen If Amazon Gets Into the Prescription Drug ...
Healthline-16 hours ago
Morgan Stanley estimates that mail-order prescriptions account for about $106 billion of the $465 billion U.S. pharmaceutical business. Amazon's entry into this market would boost the company's bottom line. But if and when Amazon opens up an online pharmacy, it will find the market dominated by Walgreens, CVS Health,
North Texas pharmacies struggling to keep Tamiflu in stock
FOX 4 News-10 hours ago
Pharmacies across North Texas are struggling to keep Tamiflu in stock as the flu season hits hard. The CD recently identified Texas as having one of the largest spikes in flu cases in the country. One of the largest pharmacies in Tarrant county almost ran out of Tamiflu last week. And one emergency room is even increasing ...
Flu season surges, but health official says 'the majority of cases ...
Fort Worth Star Telegram-19 hours ago
Fort Worth Star Telegram-19 hours ago
Chicago Acts to Address Pharmacist Workload and Patient Safety
Pharmacy Times-26 minutes ago
Many have decried that prescription errors are relat-ed to the increasing pressure facing pharmacists to fill more prescriptions. Additionally, pharmacists are asked to provide services such as vaccinations, adher-ence calls, and other ancillary activities. Recently, NBC 5 in Chicago, Illinois, reported that pharmacy metrics ...
Pressure's On CVS As Walgreens US Pharmacy Sales Rise
Forbes-19 minutes ago
Buoyed by new pharmacy partnerships to drive prescriptions through its stores, Walgreens Boots Alliance Thursday reported improved U.S. drugstore revenue at the expense of its chief rival, CVS Health. On Thursday, Walgreens, the U.S. largest drugstore chain, said fiscal 2018 first quarter net earnings were down 22% to ...
Wednesday, January 3, 2018
High Importance from the Oklahoma Board of Pharmacy
From the Inspector’s Desk
♦ 18.01. Nonsterile Compounding: A retail pharmacy may
no longer provide any nonsterile compounds to physicians
for “office use.”
♦ 18.02. CDS Invoices: When receiving controlled dangerous
substances (CDS) from the wholesale distributor, the
person checking in the drugs must either circle the quantity
received for each drug, place a check mark by the quantity
received for each drug, or make a notation that all drugs
were received.
♦ 18.03. Compounding in Anticipation of a Prescription:
Per Drug Enforcement Administration (DEA), a retail
pharmacy cannot prepare in anticipation more than a 30-
day supply of a compounded preparation containing a CDS.
♦ 18.04. CDS Prescriptions: In Oklahoma, a physician cannot
issue multiple prescriptions to a patient for the same drug.
DEA allows this, but the Oklahoma Bureau of Narcotics
and Dangerous Drugs does not have a corresponding law or
rule that allows it in Oklahoma. It is illegal for a prescriber
to postdate a prescription. All CDS prescriptions must be
dated and signed on the day when issued. If a prescriber does
not want the patient to fill it that day, then he or she can put
instructions on the prescription as to the date when it can be
filled. The date to be filled should not exceed 30 days from
the date written for Schedule II prescriptions.
♦ 18.05. BUDs for Nonsterile Compounded Preparations:
For water-containing or aqueous-based topical/dermal and
mucosal liquid and semisolid formations, the beyond-use
date (BUD) may not exceed 30 days. For aqueous-based
oral formulations, the BUD may not be longer than 14
days when stored under refrigeration. Even when you add
an active pharmaceutical ingredient (API) to a commercial product that has an aqueous component, the BUD should
not exceed 14 days when refrigerated.
For non-aqueous formulations, the BUD may not exceed the
earliest expiration date of any API or six months, whichever
is earlier.
Watch the expiration dates for all ingredients used, including
inactive ingredients. The BUD cannot exceed the expiration
date of any ingredient used in compounding the preparation.
The USP standards listed above may be exceeded when there
is supporting scientific stability information that is directly
applicable to the specific preparation (eg, the same drug,
same brands, concentration range, pH, excipients, vehicle,
water content).
♦ 18.06. Topical Compounds in Syringes Labeled “For
Oral Use”: Please do not dispense topical compounded
products in syringes labeled “for oral use” unless you have
covered or removed the words “for oral use.” The Board
has received reports of patients receiving topical medications
by mouth, particularly when the person administering
the medication is not the same as the person who received
counseling on the prescription.
♦ 18.07. BUD for Repackaged Drugs: Food and Drug
Administration (FDA) recently released a repackaging
guidance that changes the acceptable expiration date for
repackaged medications. The guidance applies to FDAregistered
repackaging firms that are repackaging solid oral
dosage forms into unit-dose containers. It does not apply to
solid oral dosage forms repackaged by state-licensed pharmacies,
nor to other dosage forms (sterile, liquid, or topical).
Retail and hospital pharmacies that repackage into unit dose
for use within their own hospital are exempt and may continue
to use a one-year expiration date or the manufacturer’s
expiration date, if it is less than one year.
♦ 18.08. CBD Oil: According to the Oklahoma Bureau
of Narcotics, cannabidiol (CBD) oil with any detectable
amount of delta-9 tetrahydrocannabinol (THC) is not legal
to sell. It is extremely difficult, if not impossible, to remove
all THC from a natural source of CBD oil. Synthetic CBD
oil is permitted if there is no detectable quantity of THC.
The Board recommends that if a pharmacy chooses to sell
CBD oil, the pharmacy should obtain a certificate of analysis
or have the product independently tested for the presence
and quantity of THC. There have been many reports of
products that have purported to contain no THC, but have
tested otherwise.
Pharmacies dispensing CBD products containing no more
than 0.3% THC must be enrolled in an FDA-approved
clinical trial.
In order for a person aged 18 years or younger to receive
CBD containing no more than 0.3% THC, he or she must
either be participating in a clinical trial or receive a written
certification from a physician licensed in this state as
having been diagnosed with Lennox-Gaustaut syndrome;
Dravet syndrome, also known as severe myoclonic epilepsy
of infancy, or any other severe form of epilepsy that
is not adequately treated by traditional therapies; spasticity
due to multiple sclerosis or paraplegia; intractable nausea
and vomiting; or appetite stimulation with chronic wasting
diseases. The CBD must be delivered to the patient in the
form of a liquid.
Pursuant to Oklahoma Statutes Title 63, Section 2-101,
industrial hemp from the plant Cannabis sativa L. and any
part of such plant, whether growing or not, with a THC
concentration of not more than three-tenths of one percent
(0.3%) on a dry weight basis shall not be grown anywhere
in the state of Oklahoma but may be shipped to Oklahoma.
♦ 18.09. Clarification of Transferring “On-Hold” CDS
Prescriptions: DEA has issued a statement allowing
pharmacies to transfer “on-hold” Schedule II-V electronic
prescriptions from one pharmacy to another if they had not
been filled at the original pharmacy. However, DEA requires
the transfer to be done electronically, and the electronic
prescriptions for controlled substances (EPCS) software
does not permit pharmacies to transmit prescriptions from
one pharmacy to another. Fax transmittal is not considered
to be electronic transmission. If software is changed to
accommodate the requirements of EPCS, then “on-hold”
CDS prescriptions may be transferred between pharmacies.
DEA does not permit pharmacies to transfer “on-hold” CDS
prescriptions that have been received by any other means
of communication, including facsimile, verbal, or written.
These requirements do not apply to the transfer of refills
of CDS prescriptions. Refills may be transferred as per
Oklahoma Administrative Code 535:15-3-12 and 535:15-
3-12.1.
quoted from the January 2018 Oklahoma Board of Pharmacy Newsletter
quoted from the January 2018 Oklahoma Board of Pharmacy Newsletter
Statement from FDA Commissioner Scott Gottlieb, MD on new steps ...
FDA.gov-7 hours ago
The FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components: reducing gaming by branded companies that can delay generic drug entry; resolving scientific and regulatory obstacles that can ...
How Will the Supplement Industry Fare without Hatch?
MedPage Today-59 minutes ago
Orrin Hatch (R-Utah), the supplement industry may have to look for a new champion. Hatch, the longest serving Republican in the Senate, announced plans to retire in early 2019, according to the Salt Lake Tribune. He was one of the primary authors and "the moving force" behind the Dietary Supplement Health and .
Sen. Hatch to Retire, Leaving Void for Dietary Supplement Industry
Natural Products INSIDER (blog)-6 hours ago
It was Hatch who co-authored the Dietary Supplement Health and Education Act of 1994 (DSHEA). Since the passage of DSHEA, the industry has grown exponentially with tens of billions of dollars in annual sales. And over the years as critics have questioned the regulatory framework governing supplements, Hatch has ...
Rolly: Hatch is going out on top, but history will show whether he ...
In-Depth-Salt Lake Tribune-22 hours ago
In-Depth-Salt Lake Tribune-22 hours ago
Critics Say FIFA Is Stalling a Doping Inquiry as World Cup Nears
New York Times-10 hours ago
With the Russia World Cup six months away, leaders of the antidoping movement are criticizing soccer's governing body over its failure to pursue more aggressively whether Russian authorities covered up positive doping tests belonging to the country's top soccer players. Travis Tygart, the head of the United States ...
Do Formulary Lists Reduce Patient Access to Prescription Drugs?
Specialty Pharmacy Times-6 hours ago
Formulary lists are used by pharmacy benefit managers (PBMs) to control costs and prevent unnecessary drug spending by incentivizing the use of lower cost and generic medications over costlier branded products. PBMs say this practice reduces overall spending on prescription drugs and helps patients lower their ...
Why pharmaceutical companies, under attack for drug prices, started ...
Chicago Daily Herald-16 hours ago
Chicago Daily Herald-16 hours ago
4 Things Pharmacists Should Know About the Shingrix Vaccine
Pharmacy Times-1 hour ago
Shingrix (Zoster Vaccine Recombinant, Adjuvanted) was approved in October 2017 for adults 50 and older for the prevention of shingles, a viral infection that causes a painful rash that generally develops on 1 side of the body, usually the face or torso. The risk of shingles and post-herpetic neuralgia (PHN) increases with ...
HEE outlines future workforce strategy for pharmacy
The Pharmaceutical Journal-11 hours ago
It said it aimed to “future proof” the NHS workforce, and while it acknowledged the role of pharmacy in new models of care and workforce programmes outlined in the NHS Five Year Forward View, there was no commitment to new strategies or funding for the sector. The Royal Pharmaceutical Society welcomed the ..
US District Court Rules Against 340B Hospitals
Pharmacy Practice News-4 hours ago
... program allows participating hospitals to use the savings from the discounts to provide an expanded range of comprehensive health services to their local communities, such as increased access to care, clinical pharmacy services, community outreach programs, free vaccines and transportation to follow-up appointments.
Are Canadian Pharmacies the Solution to America's High ...
Reason (blog)-4 hours ago
A pharmacy in Toronto, where all the good cheap drugs are. Photo credit: Rene Johnston Toronto Star/ZUMA Press/NewscomEvery day for the last three years, I've started my morning with four prescription pills that cost roughly $11 each. I say "roughly" because the price fluctuates. The last time I filled a 90-day prescription, ...
| FDA revokes draft compounding guidance
The new guidance will replace the draft document "Compounding Animal Drugs from Bulk Drug Substances," which was published in May 2015. It described FDA interpretations of the legality of compounding animal drugs from bulk pharmaceutical substances and indicated when the FDA would ...
|
Seven key changes the new tax law will force hospitals to consider
The Tax Cuts and Jobs Act will force not-for-profit hospitals to grapple with changes that make their tax-exempt status less advantageous, including new provisions on unrelated business taxable income and executive compensation. READ MORE
Tuesday, January 2, 2018
| 11/30/2017 | TruVision Health LLC | Denver District Office | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | Not Issued * |
| 12/18/2017 | Fresenius Kabi Oncology Limited (Baddi) | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
| 12/18/2017 | Prosana Distribuciones SA de CV | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded | Not Issued * |
| 12/18/2017 | Prosana Distribuciones SA de CV | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded | Not Issued * |
Monday, January 1, 2018
Doping In Sports - Cheating Or Leveling Of The Playing Field?
Forbes-Dec 31, 2017
On December 5, 2017, the International Olympic Committee (IOC) banned Russia from taking the national team to the February 2018 winter games in Pyeongchang, South Korea. This decision was a punishment for running a state-sponsored dopingprogram. If Russian athletes independently prove they are clean, they can ...
Nevada State Board of Pharmacy Notice of Intent to Act Upon A Regulation
01/11/2018 9:00AM
Meeting Notice
Meeting Notice
Nevada State Board of Pharmacy
Notice of Intent to Act Upon a Regulation
Hilton Garden Inn - 7830 South Las Vegas Blvd. - Las Vegas, NV
Notice of Intent to Act Upon a Regulation
Hilton Garden Inn - 7830 South Las Vegas Blvd. - Las Vegas, NV
Nevada State Board of Pharmacy Regulation Workshop
01/11/2018 9:00AM
Meeting Notice
Meeting Notice
Nevada State Board of Pharmacy
Regulation Workshop
Hilton Garden Inn - 7830 S. Las Vegas Blvd. - Las Vegas, NV
Regulation Workshop
Hilton Garden Inn - 7830 S. Las Vegas Blvd. - Las Vegas, NV
Iowa Board of Pharmacy Notices of Intended Action proposing amendments to various Board Rules
Date:
Tuesday, December 26, 2017
The Board of Pharmacy has filed Notices of Intended Action (NOIA) proposing amendments to various Board rules. The Board is soliciting comments and suggestions regarding those proposed amendments.
The NOIAs are available at https://rules.iowa.gov/ and comments can be submitted directly through the NOIA -- follow the prompts on the website. Comments may also be submitted via mail or email as identified in the NOIA.
The following ARC numbers identify the NOIAs that are currently available for comment. Comments are due not later than 4:30 p.m. on January 19, 2018.
ARC 3505C
ARC 3506C
ARC 3507C
ARC 3508C
ARC 3509C
ARC 3510C
ARC 3511C
ARC 3512C
ARC 3506C
ARC 3507C
ARC 3508C
ARC 3509C
ARC 3510C
ARC 3511C
ARC 3512C
The Board also adopted previously proposed amendments to 657 Chapter 16, Nuclear Pharmacy Practice. The amendments will become effective January 24, 2018, and are available on the same Rules website as ARC 3525C.
FDA bans triclosan, 23 other antiseptic ingredients
Pharmacy Today, American Pharmacists Association, pharmacist.com-Dec 28, 2017
FDA has finalized a rule banning the marketing of OTC healthcare antiseptic products containing triclosan or any of 23 other active ingredients, having found these ingredients are not generally recognized as safe and effective (GRASE). FDA has finalized a rule banning the marketing of OTC healthcare antiseptic products .
Theranos gets $100 million lifeline from Fortress
Pharmacy Today, American Pharmacists Association, pharmacist.com-Dec 28, 2017
The blood-testing company Theranos Inc. told its investors this week that it has secured a $100 million loan from Fortress Investment Group LLC, averting for now a possible bankruptcy filing as its remaining cash dwindled. The blood-testing company Theranos Inc. told its investors this week that it has secured a $100 ...
Appeals court asked to rule on pharmacy slaying conviction
Tulsa World-Dec 30, 2017
Former pharmacist Jerome Jay Ersland is taking his last-ditch challenge of his murder conviction to the federal appeals court in Denver. Ersland, 66, is serving a life sentence for fatally shooting an unarmed, already wounded teenage robber in 2009 inside an Oklahoma City pharmacy. He is not eligible for parole until 2049.
Pharmacists slow to dispense lifesaving overdose drug
WBIR-TV-Dec 30, 2017
Gale Dunham, a pharmacist in Calistoga, Calif., knows the devastation the opioid epidemic has wrought, and she is glad the anti-overdose drug naloxone is becoming more accessible. But Dunham said that so far, she has not taken advantage of a California law that allows pharmacists to dispense the medication to ...
All My Pharmacy Students Learn to Code
Pharmacy Times-Dec 27, 2017
We all know that health care is changing rapidly. The mobile phone, augmented by health and wellness trackers, apps, and sensors is shifting care into the home. Pharmacists must be leading new practice model initiatives and, at a minimum, be familiar with connected technology. The chief clinical officer of Partners
For Pharmacist Turned CEO: CVS' Larry Merlo Faces Biggest ...
Hartford Courant-Dec 31, 2017
When Larry J. Merlo took the CEO job at CVS in 2011, some wondered if his experience heading the drugstore chain's retail operations had prepared him enough to tackle CVS's strategic transition into a health care company. But since assuming the helm, Merlo steadied a faltering merger with pharmacy benefits manager ..
New Nevada law aims to tackle opioid epidemic
Las Vegas Review-Journal-9 hours ago
The Prescription Drug Abuse Prevention Act, passed by the 2017 Legislature, outlines safeguards for doctors before they prescribe controlled substances to treat pain and increases requirements ... At 27, Wells injured his spinal cord while snowboarding, an injury compounded by an unnecessary surgery years later.
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