Wednesday, July 2, 2014

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Senior Specialty Sales Representative
Transdermal Therapeutics

Peoria - Jul 1, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

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Senior Specialty Sales Representative
Transdermal Therapeutics

Glendale - Jul 1, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

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Senior Specialty Sales Representative
Transdermal Therapeutics

Tuscon - Jul 1, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Sun City - Jul 1, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Chandler - Jul 1, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Mesa - Jul 1, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Scottsdale - Jul 1, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Phoenix - Jul 1, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Sun City - Jun 23, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Glendale - Jun 23, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Peoria - Jun 23, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Scottsdale - Jun 23, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Mesa - Jun 23, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Chandler - Jun 23, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Tuscon - Jun 23, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

View
Senior Specialty Sales Representative
Transdermal Therapeutics

Phoenix - Jun 23, 2014

Transdermal Therapeutics is expanding in your area! In three years our physician owned and operated company has tripled in size and has recently moved to its third lab. Compounded pain creams are the ABSOLUTE FUTURE of pain management. ...

The Long Heard Rumors Are True: PCAB Accreditation Becomes a Service of ACHC - 12 News KBMT and K-JAC. News, Weather and Sports for SE Texas

PCAB Accreditation Becomes a Service of ACHC - 12 News KBMT and K-JAC. News, Weather and Sports for SE Texas

Tuesday, July 1, 2014

Washington State Pharmacy Quality Assurance Commission July 2014 Newsletter

here

Virginia Board of Pharmacy Frequently Cited Deficiencies

Frequently Cited Deficiencies

The deficiencies referenced below may be reviewed in

Guidance Document 110-9, found at www.dhp.virginia

.gov/pharmacy/pharmacy_guidelines.htm.

Perpetual inventory (Major Deficiency 15) continues

to be the most frequently cited major inspection

deficiency. Board Regulation 18VAC110-20-240 states

that each pharmacy shall maintain a perpetual inventory

of all Schedule II drugs received and dispensed, with

reconciliation at least monthly. This includes slow moving

and expired drugs. During the inspection, you will

be asked to provide the inspector with documentation

of compliance for 10 different drugs over a six-month

period. The perpetual inventory record must accurately

indicate the physical count of each Schedule II drug

“on-hand” at the time of performing the inventory. To

comply with the requirement to perform the required

“reconciliation” of the perpetual inventory, an explanation

for any difference between the physical count and

the theoretical count must be noted (refer to Guidance

Document 110-16).

The second-most frequently cited minor deficiency

(Minor Deficiency 13) is when a required inventory is

taken on time but does not include the required components,

such as not being signed and dated by the person

taking the inventory; failing to indicate whether the

inventory was taken prior to the opening of business or

after close of business; and not listing drugs in Schedule

II separately from drugs in Schedules III, IV, and

V. Additionally, it is cited when pharmacies are open

24/7 and fail to clearly document whether the receipt

or distribution of drugs on the inventory date occurred

before or after the inventory was taken.

Guidance Documents

Board Guidance Documents are available at www.dhp

.virginia.gov/Pharmacy/pharmacy_guidelines.htm. The

following Guidance Documents have been added or

amended since December 2013:

♦♦110-9: Pharmacy Inspection Deficiency Monetary

Penalty Guide

♦♦110-17: Instructions for Graduates of Foreign

Schools of Pharmacy

♦♦110-23: Practitioner of the Healing Arts Selling

Controlled Substances Inspection Deficiency Monetary

Penalty Guide

♦♦110-22: Use of Dispensing Records to Identify

Pharmacist Responsible for Dispensing Error

♦♦110-27: Pharmacist-in-charge Responsibilities

♦♦110-36: Compliance with USP Standards for Compounding

♦♦110-38: Requirement for Non-resident Pharmacies

to Submit Current Inspection Report

quoted from here

Virginia Board of Pharmacy Gloved Fingertip Sampling Not Being Performed as required by 797

Gloved Fingertip Sampling

During inspections it has been observed that gloved

fingertip sampling is not always being performed. The

requirement in USP Chapter <797> is that

All compounding personnel shall successfully

complete an initial competency evaluation and

gloved fingertip/thumb sampling procedure

(zero [colony-forming units]) no less than three

times before initially being allowed to compound

[compounded sterile products (CSPs)] for human

use. After completing the initial gowning and

gloving competency evaluation, re-evaluation of

all compounding personnel for this competency

shall occur at least annually for personnel who

compound low and medium-risk level CSPs and

semi-annually for personnel who compound

high-risk level CSPs using one or more sample

collections during any media-fill test procedure

before they are allowed to continue compounding

CSPs for human use.

Please note, documentation of completion of gloved

fingertip sampling must be available for each individual

who engages in the preparation of compounded sterile

drug products.
quoted from here

Virginia Board of Pharmacy Law Regarding Prescriptions Written for Office Use Only

Prescriptions Written for ‘Office Use

Only’

A pharmacy may provide prescription drugs to a physician

for office use in accordance with §54.1-3435.02

of the Drug Control Act, which states that

A permitted pharmacy may engage in wholesale

distributions of small quantities of prescription

drugs without being licensed as a wholesale

distributor when such wholesale distributions

are in compliance with federal law as follows:

such wholesale distributions of controlled

substances do not exceed five percent of

the gross annual sales of prescription drugs

by the relevant permitted pharmacy or such

wholesale distributions of Schedules II through

V controlled substances do not exceed five

percent of the total dosage units of the Schedule

II through V controlled substances dispensed

annually by the pharmacy.

Occasionally, a physician will request prescription

drugs by providing the pharmacy with a prescription

indicating “For Office Use Only” in the name field. This

does not constitute a valid prescription because it is not

issued in the name of a specific patient for a specific drug

that resulted from a bona fide practitioner-patient relationship.

Pharmacists must not dispense prescriptions

written “For Office Use Only.” To properly transfer the

requested drugs, the pharmacist must create an invoice

containing the following information: the date of transfer,

the name and address of the physician to whom the

drugs are to be transferred, the name and address of the

pharmacy from where the drugs were transferred, and

the kind and quantity of drugs transferred. The transferring

pharmacy maintains the original invoice for two

years from the date of transfer and provides a copy to

the receiving physician or pharmacy. Once received,

the physician must indicate the date of receipt on the

invoice and maintain the invoice for two years from

the date of receipt. If the requested drug is classified as

Schedule II, the physician wishing to obtain the drug

must execute a Drug Enforcement Administration (DEA)

Form 222 as the “purchaser” and provide this form to

the transferring pharmacy. The transferring pharmacy

would then complete DEA Form 222 acting as the “supplier”

in this instance. Copies of DEA Form 222 must

then be properly forwarded as required by federal law.

If maintaining a separate record of the distribution

electronically in the pharmacy’s computer, pharmacists

must ensure that the information is not transmitted to

the PMP with other dispensing records. Assigning a

“prescription” number to the transaction may result in

the distribution information being uploaded to the PMP
quoted from here

Virgina Board of Pharmacy Rule Effective July 1, 2014 Regarding Dispensing of Tramadol

Dispensing of Tramadol Must Be

Reported to the PMP

Effective July 1, 2014, §54.1-3456.1 of the Drug

Control Act adds “drugs of concern” as covered substances

that must be reported to the Virginia Prescription

Monitoring Program (PMP) when dispensed. The

supporting legislation, House Bill (HB) 874, specifically

states that “drugs of concern” shall include any material,

compound, mixture, or preparation that contains

any quantity of the substance tramadol. The legislation

further authorizes the Board to promulgate regulations to

designate other specific drugs and substances as “drugs

of concern” if warranted.

Please note that the legislation did not place tramadol

into a different drug schedule. Tramadol remains

a Schedule VI controlled substance in Virginia and is

subject to all requirements associated with a Schedule

VI drug. The only change in requirements is that the

dispensing of tramadol must be reported to the PMP

beginning July 1, 2014.

Please contact your pharmacy software application

vendor for instructions on actions you may need

to take to start reporting the dispensing of tramadol

prescriptions as of July 1, 2014. HB 874 may be accessed

at http://leg1.state.va.us/cgi-bin/legp504

.exe?141+ful+CHAP0664.

Virginia Board of Pharmacy July 2014 Newsletter

read here

Oklahoma State Board of Pharmacy From Inspector's --Regarding Providing Filled Prescriptions to Patients in Other States

From the Inspector’s Desk

♦♦14.15. Pharmacies Providing Filled Prescriptions to

Patients in Other States: Oklahoma licensed pharmacies

that mail or ship filled prescriptions to patients

in other states must review the licensing requirements

of the state into which they are sending medications

in order to assure compliance with that state’s laws.

Nearly all states require that out-of-state pharmacies

shipping products into their state be licensed by the

state into which they are shipping. Many states also

require that the pharmacist-in-charge (PIC) be licensed

to practice pharmacy in that state. In addition, state

laws should be reviewed on a regular basis to determine

if there have been changes in licensing requirements.

Many states are implementing more stringent

regulations and rules regarding prescriptions shipped

across state lines.
quoted from Oklahoma Board of Pharmacy July 2014 Newsletter

Oklahoma State Board of Pharmacy takes Action Against Stacie M. Miller, DPh --compounding

Stacie M. Miller, DPh, #13125 – Case No. 1266: Admitted

to guilt on seven counts and neither admits nor

denies guilt on 6,530 counts including attempting diagnosis

or treatment that might infringe upon the legally

constituted right or obligation of any practitioner of the

healing arts; failing to oppose any secret arrangement

between pharmacist and physician whereby fees are

divided; making or filing a report or record that she

knew or should have known to be false; submitting

fraudulent billing or reports to a third party payor of

prescription drugs; filling or refilling a prescription

without authorization; allowing an intervening person

to alter a prescription order; allowing someone other

than an authorized practitioner or his or her designated

agent to transmit prescription drug orders; entering into

an agreement with a practitioner that requires that prescription

orders be transmitted from the practitioner to

only the pharmacy; failing to maintain reports; failing

to supervise employees; failing to comply with United

States Pharmacopeia Compounding Standards; failing

to ensure the validity of all prescriptions; failing to

document training of a currently permitted technician;

billing or charging for quantities greater than delivered;

misfilling a prescription; substitution without

authorization; filling a prescription without a license;

entering into an arrangement whereby prescription

orders are received or delivered at a place other than

the pharmacy in which they are compounded and dispensed;

filling a written prescription that has not been

manually signed by the practitioner; and failing to

handwrite the initials of the pharmacist on a controlled

dangerous substance (CDS) prescription. License is

suspended for six years until April 16, 2020, and

$10,000 fine. After one year, suspension is stayed

and respondent’s license is placed on probation for

five years. Respondent may not work as a PIC in a

pharmacy until after April 16, 2020.

Oklahoma Board of Pharmacy July 2014 Newsletter

read here

The case of Makena: Speaking out against unfair drug pricing

I’m 34 weeks pregnant and working hard to keep this baby inside me for as long as possible. As with my last pregnancy, there’s a real risk that the baby could come too early. But we’re both holding on so far, thanks to a combination of luck, modified bed rest and medical science.

The science is my biggest concern right now. I will spare you much of it because, man or woman, you will instinctively cringe and close your legs. However, one critical medical intervention that has been proven to work for countless women and babies is again under threat, and I must speak up.
Every week, my husband injects me with 250 mg (1 ml) of 17 alpha-hydroxyprogesterone caproate (“progesterone” for short). Leaving aside what this does to an otherwise tender and loving marriage, these injections have been found to significantly lower the risk of preterm birth.
Two weeks ago, my insurance co-pay for progesterone went from $5.50 per dose to $70 per dose. Just like that. For those without insurance (or with a deductible), the medication went from $32.50 per dose, according to my local compounding pharmacy, to $833 per dose, according to the new pharmacy my insurer is now requiring me to use.
$833. Per. Dose.
Pricing varies somewhat across pharmacies and insurers, but not enough to make this price change any less breathtaking. In fact, the drug’s list price is $690 per dose.
continue to read here

Job Opening: Compound Pharmacy Sales Reps ASAP! (Lutz)

We are looking to build a team of sales reps specializing in Compound Pharmacy sales and Sterile Compounding.

Ready to hire ASAP!

MUST HAVE EXPERIENCE:

Compound Pharmacy Sales
Knowledge of Drugs and Compounding Terminology
Outstanding Sales Record

Looking for Change?
New AWESOME environment?
Better Earnings that your currently receiving?

Send your CV for immediate consideration.

Thank you, and GOOD LUCK TO ALL!!

Principals only. Recruiters, please don't contact this job poster.
do NOT contact us with unsolicited services or offers

post id: 4548995061

quoted from here

Drug Recalls Soared Again, Driven by Contamination

Drug Recalls Soared Again in 2013, Driven by Contamination / FDA reported 1,276 drug recalls last year, the third-highest level ever. Inspections of pharmacies that compounded purportedly aseptic injectables drove the numbers, but pharmaceutical manufacturers also contributed as they struggled with particulates, precipitation and other issues. / “The Pink Sheet” June 30 2014 12:00 AM

Job Opening: Entry Level Pharmacy Investigator/Inspector in North Carolina

FRIDAY, JUNE 20, 2014
The NC Board of Pharmacy has an opening for an entry level Investigator/Inspector.
The primary duties of the position will be to conduct inspections and investigate complaints of pharmacies covering the counties of Wake, Durham, Orange, Person, Vance, Granville, and Franklin in North Carolina. Duties may also include conducting investigations on pharmacists, pharmacies, pharmacy technicians and/or medical and/or durable medical permitees as assigned by the Director or Assistant Director of Investigations and Inspections. The applicant must be able to review and/or audit pharmacy, healthcare and other records for proper documentation; analyze records for problems with prescriptions and other dispensing issues. The applicant must be able to compile data, compile an investigatory report and testify at Board hearings, court trials, or in other settings.
The inspections and investigations conducted by the investigator/inspector deal with allegations of violations of applicable state and federal laws, rules, and regulations of the NC Board of Pharmacy.
Requirements for application for the inspector/investigator position require a four-year degree from an accredited college or university; one year of investigation or inspection experience; or a two-year degree from an accredited university or college and equivalent investigative or inspection experience. Applicants are required to be a resident of North Carolina, have a valid NC driver’s license, and bring a certified copy of a criminal background check from their local county Clerk of Superior Court. It is recommended that applicants live in one of the counties mentioned above.
All applicants should submit a cover letter of interest along with a resume by Sunday, July 20, 2014, to Joshua Kohler, Director of Investigations and Inspections.

Notice of Public Hearing September 16, 2014 on Proposed Amendments Relating to Compounding in North Carolina

MONDAY, JUNE 23, 2014 - COMPOUNDING RULE AMENDMENTSNOTICE OF PUBLIC HEARING (SEPTEMBER 16, 2014) ON PROPOSED AMENDMENTS TO RULES 21 NCAC 46 .1412 AND .2801; AND PROPOSED REPEAL OF 21 NCAC 46.1810 AND .2802-.2808 - COMPOUNDING. Revisions required by the federal Drug Quality and Security Act (Public Law No. 113-54), with accompanying revisions to simplify and consolidate the Board of Pharmacy's rules governing compounding of drug preparations.
A public hearing will be held on September 16, 2014 at 9:00am at the NC Board of Pharmacy office, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517.
Any person may object to the proposed amendment by attending the public hearing on September 16, 2014 and/or by submitting a written objection by 9:00am on September 16, 2014 to Jay Campbell, Executive Director, North Carolina Board of Pharmacy, 6015 Farrington Road, Suite 201, Chapel Hill, NC 27517, fax (919) 246-1056, e-mail jcampbell@ncbop.org. The North Carolina Board of Pharmacy is interested in all comments pertaining to the proposed rule. All persons interested and potentially affected by the proposal are strongly encouraged to read this entire notice and make comments on the proposed rule.
If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission. If the Rules Review Commission receives written and signed objections in accordance with G.S. 150B-21.3(b2) from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1). The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or facsimile transmission. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 919-431-3000.

• NOTICE OF TEXT/PUBLIC HEARING:
http://www.ncbop.org/LawsRules/1412_2801_1810_2802through2808CompoundingNoticeOfTextJune2014.pdf

• PROPOSED RULE/AMENDMENT LANGUAGE:
Amendment: 21 NCAC 46.1412: http://www.ncbop.org/LawsRules/1412ProposedAmendCompoundingJune2014.pdf
Amendment: 21 NCAC 46.2801: http://www.ncbop.org/LawsRules/2801ProposedAmendCompoundingJune2014.pdf
Repeal: 21 NCAC 46.1810: http://www.ncbop.org/LawsRules/1810ProposedRepealCompoundingJune2014.pdf
Repeal: 21 NCAC 46.2802 - .2808: http://www.ncbop.org/LawsRules/2802_through_2808ProposedRepealCompoundingJune2014.pdf

Novartis Unit Charged By Japan Over Research Data

Ed Silverman

The clinical research scandal in Japan has now formally ensnared Novartis NOVN.VX +1.00%. Prosecutors have brought charges against the drug maker’s local unit, and re-arrested a former employee for allegedly altering data in a study involving the Diovan blood pressure drug in order to make the medicine appear better than rival treatments, The Wall Street Journal writes.
continue to read here

List of FDA Compounding Regulatory Policy Information

Compounding Regulatory Policy Information

Updated Compounding Registered Outsourcing Facilities

Compounding Registered Outsourcing Facilities

2014 Pharmacy Creations 6/23/14--warnings regarding this practice in a Warning Letter issued on October 31, 2006, and in a meeting with FDA on June 11, 2008. Domperidone is not the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, nor is it a component of an FDA-approved human drug product, nor does it appear on a list developed by the Secretary under section 503A(b)(1)(A)(i)(III) of the Federal Food Drug, and Cosmetic Act (FDCA) [21 U.S.C.§353a].

2014 Pharmacy Creations 6/23/14

Recalls, Market Withdrawals, & Safety Alerts Bristol-Myers Squibb Issues Voluntary Nationwide Recall of COUMADIN (Warfarin Sodium) for Injection Due to Presence of Particulate Matter

Compounding Solutions Announces New Medical Color Concentrate Line | Qmed

Second Question of the Day July 1, 2014 How many times does an animal or human take a compounded medication based on preference of the patient or the doctor? Is this a valid, legal reason?

How many times does a doctor prescribe a compound simply because he or she prefers a compounded preparation nor because their is a legitimate basis for the compounded preparation? How many times does the doctor provide false documentation for the compounded preparation? Shouldn't the justification be patient-specific rather than a general theory such as all kids have trouble taking pills so the medication needs to be made into a sucker. This general statement is false: some kids can take pills; some can't. Likewise, a general statement that animals are hard to give pills should not be a valid basis. For example, I have been successful giving most of the cats I have owned pills and in fact sometimes the pills are easier to give to a cat than a liquid preparation in a dropper. Should it be a valid basis simple because a doctor thinks the compounded preparation works a little better than the commercially available even though the commercially available still works? For example assume there is a commercially available drug to treat infertility in females. In studies, it works 90 percent of the time and the female ends up having a baby. Assume also compounding pharmacies make a very similar if not identical commercially available drug to treat infertility in females. Studies by compounding groups suggest this preparation works 95 percent of the time but of course the studies required by the FDA for the drug to be approved and commercially available have not been done. The patient has never tried the commercially available or the compounded preparation. The doctor prefers the compounded preparation because he likes to help the pharmacist stay in business so he or she always prescribes it. Problems? Legal? Illegal? Should the doctor be prosecuted? Fined? Should the pharmacist who clearly knows what is happening be prosecuted? Fined? How can it be patient-specific and valid when the patient has no idea if the commercially available will work? What if the patient tries the commercially available for six months with no success and then the doctor prescribes the compounded medication? Doesn't this change the legality of the prescription, but again how many times is this being done in actual practice?

Question of the Day July 1, 2014 Will we see more of the bad and illegal compounding pharmacies close their doors in light of the new laws and new insurance policies of major companies?

One Way Drug, LLC (dba Partell Specialty Pharmacy), Las Vegas, NV 5/30/2014

One Way Drug, LLC (dba Partell Specialty Pharmacy), Las Vegas, NV

483 Issued 5/30/2014¹¹⁹ (PDF - 1.3MB)

Express Scripts Ends Coverage for 1,000 Compound Drug Ingredients

Ed Silverman

An arcane change in how compound pharmacies bill for their products, as well as supply-and-demand issues, have caused a spike in costs that is prompting pharmacy benefits managers to restrict their coverage for the medicines.
The latest, and perhaps, the most drastic response comes from Express Scripts ESRX -0.38%, which this week will begin blocking coverage for approximately 1,000 active ingredients – an assortment of ointments, creams and powders – that are widely used by compounding pharmacies to create countless topical treatments, an Express Scripts executive tells Pharmalot.
Over the past two years, Express Scripts has seen the number and cost of prescriptions for compounded medicines used for treating scars, wrinkles and pain rise dramatically.
For instance, the average cost for each prescription rose to $1,100 from $90, and for about a dozen such medications, the actual cost jumped by more than 1,000%. Consequently, the amount spent by its clients for compounded drugs increased to roughly $171 million in this year’s first quarter, up from $28 million during the comparable period in 2012.
“It’s an issue of waste,” says Glen Stettin, senior vice president for clinical, research and new solutions. “For nearly all of these products, there’s already a commercial preparation already available – a generic or brand-name product approved by FDA. And there is no evidence to support their use at all.”

continue to read here

Mass. Lawmakers Pass Compounding Pharmacy Bill « CBS Boston

Scandal charges strike nerve during House budget debate

read here

FDA tightens oversight of pharmacies | TheHill

FDA Outlines Guidance and Rules for Compounding Drug Products

FDA has outlined its guidance and rules for the compounding of drug products by releasing policy documents as part of the agency’s effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.
“Providing clarity to the compounding industry on the agency’s expectations for these unapproved drug products is a priority for the agency,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a press release. “These actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA’s efforts to continue protecting patients.”

continue to read here

Member Feedback Requested on Proposed Sterile Compounding Regulations

June 30, 2014 BJ Bartleson, RN, MS, NEA-BC

The California State Board of Pharmacy has produced a new draft of proposed regulations for pharmacies that compound or compound sterile preparations. The changes will be considered by the board for release for a 45-day comment period during its July 30 meeting. Many of the proposed regulations affect facility and equipment standards for sterile compounding such as ventilation, negative pressure and ante rooms. It is especially important for small, rural and critical access hospitals to review the proposed regulations. In the interest of developing the best regulations, the Board of Pharmacy has granted CHA an opportunity to submit feedback on physical plant modifications by July 9.
CHA Medication Safety Committee leaders — and others who worked together to compose extensive comments to the board’s original language in January — are analyzing the new regulations and drafting comments. In addition, CHA will host an all-member call on July 8 for interested hospitals to gather information and participate in discussion of the Board of Pharmacy changes, as well as CHA’s comments and proposal.
CHA encourages all members to compare the proposed physical and plant structural changes to current compounding facility and equipment standards and submit comments to CHA on the attached proposed worksheet and/or participate in the July 8 call:
Tuesday, July 8
4 p.m. – 5 p.m.
(800) 882-3610, Passcode 5968133#
Attached are CHA’s Jan. 10 comment letter, the Board of Pharmacy proposed language and a worksheet for submitting comments.

Preparation is critical to high-risk sterile compounding; High-risk compounding should be a last resort to address drug shortages, said ASHP

July 01, 2014

Every year, FDA reports shortages of hundreds of drugs, the majority of which are sterile injectables. Currently, there are 251 drugs in shortage, 199 of which are sterile injectables, according to the American Society of Health-System Pharmacists (ASHP). These numbers are similar to those of the last 5 years, according to FDA.
In the face of drug shortages, health-system pharmacists often must perform high-risk sterile compounding, but this should be an emergency last resort, said Angela Yaniv, PharmD, Assistant Director of Pharmacy at Cleveland Clinic, at last year’s ASHP Midyear Clinical Meeting and Exhibition in Orlando, FL. Before undertaking high-risk compounding, pharmacists should ensure there is no other way to acquire the drugs. Once the procedure is deemed indispensable, pharmacists should evaluate the feasibility of the high-risk compounding procedure and take measures to ensure the products are well prepared.

Weigh your options

When a drug is in short supply, health-system pharmacists should consider the following before taking on high-risk compounding: (1) expected duration of shortage; (2) the health system’s current supply of the drug and potential for inventory management during the shortage; (3) possible alternative manufacturers or sizes available for aliquoting; (4) possible therapeutic substitutions for the drug and the need for Pharmacy and Therapeutics Committee approval; and (5) outsourcing compounding.

Members appointed to compounding task force, other entities

Don't Get Burned By Sunshine: The Latest on the Physician Payments Sunshine Act

Tuesday, July 15, 2014

12:00 PM - 1:30 PM Eastern

1.5 CLE Requested

Webinar

This webinar will cover subjects such as:

The latest developments relating to the Physician Payments Sunshine Act, including updates on related State laws;
The use of Sunshine Act data coupled with Medicare payment data and other transparency initiatives;
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FDA seeks permanent injunction against California pharmaceutical company

For Immediate Release

July 1, 2014

Release

On June 25, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede, Inc. (Laclede) of Rancho Dominguez, California, and its president, Michael A. Pellico. The complaint claims that Laclede illegally distributes over-the-counter vaginal drug products without required FDA approval.
According to the complaint, Laclede is in violation of the Federal Food, Drug, and Cosmetic Act for introducing unapproved and improperly labeled (misbranded) drugs for sale across the country. The prebiotic vaginal products named in the complaint are:

Luvena Prebiotic Vaginal Moisturizer and Lubricant
Luvena Prebiotic Enhanced Personal Lubricant
Luvena Prebiotic Feminine Wipes
Luvena Prebiotic Daily Therapeutic Wash

The complaint requests, among other things, that the court issue a permanent injunction order requiring Laclede to cease distribution of these drug products until the company obtains an approved new drug application from the FDA or until all drug claims have been removed from the products’ labels, marketing materials, and any websites controlled by or related to Laclede.
“The drug approval process is critical to ensuring that drugs are safe and effective for their intended uses,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA will take swift action when companies bypass this important process established to protect consumers from harmful products.”
Since 2010, the FDA has repeatedly told the company that it must obtain the FDA’s approval before selling its drug products. According to the complaint, the company subsequently marketed and distributed the unapproved drug products, despite the FDA’s warnings.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

HIGH IMPORTANCE!! MUST READ!!! FDA outlines expectations for human drug compounders, including registered outsourcing facilities

Today, the U.S. Food and Drug Administration issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.
“Providing clarity to the compounding industry on the agency’s expectations for these unapproved drug products is a priority for the agency,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA’s efforts to continue protecting patients.”
The documents available today are:

Draft interim guidance that describes the FDA’s expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with the FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance focuses on CGMP requirements related to sterility assurance of sterile drug products and the general safety of compounded drug products.
A proposed rule that would revise the FDA’s current list of drug products that may not be compounded because the drug products have been withdrawn or removed from the market because they were found to be unsafe or not effective. The proposed rule would modify the description of one drug product on the list and add 25 drug products to the list.

The list set forth in the proposed rule would apply to both compounders and outsourcing facilities seeking to compound drugs for human use under sections 503A and 503B, respectively.

Final guidance for individuals or pharmacies that intend to compound drugs under section 503A, now that the FD&C Act has been amended by the DQSA. The guidance generally restates the provisions of section 503A, describes the FDA’s interim policies with respect to specific provisions that require implementing regulations or other actions, and contains a non-exhaustive list of potential enforcement actions against individuals or pharmacies that compound human drug products in violation of the FD&C Act.

Two Federal Register Notices stating the FDA is reopening the nomination process for two lists of bulk drug substances (active pharmaceutical ingredients) that may be used to compound drug products. One list is for drug products compounded in accordance with section 503A, and the other list is for drug products compounded in accordance with section 503B of the FD&C Act. In response to a December 2013 request for nominations, the agency received nominations that were not for bulk drug substances used in compounding, and that did not provide sufficient information to justify inclusion of the substances on the lists.

The FDA is providing more detail on what information is needed to evaluate the nominations for placement on the lists.
The draft interim guidance and proposed rule are available for public comment for 60 days, and the dockets are open for the public to nominate bulk drug substances for compounding under section 503A or 503B for 90 days.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA seeks permanent injunction against California pharmaceutical company

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Page Last Updated: 07/01/2014

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