SHAMR CK MEDICAL - prismtest.com

A better way to repackage

SHAMR CKMEDICALEXPERTS IN DRUG REPACKAGING

www.shamrock-medical.com

Customize your facility’s drug repackaging with the experts. Contact Shamrock Medical today at 740.657.6000.

Right size. Right packaging. Right dose. Right choice.


741 Radio Drive • Lewis Center, OH 43035 • p. 740.657.6000 • f. 740.657.6006 250 Revolutionary Drive - Suite 200 • East Taunton, MA 02718 • p. 508.824.1544 • f. 508.824.1655

A better way to repackagewww.shamrock-medical.com

Leave it to the expertsWhen it comes to repackaging your

pharmaceuticals and ensuring top safety

and quality for your patients, why trust

anyone else? Shamrock Medical is the

choice of more than 200 pharmacies and

healthcare organizations for comprehensive

drug repackaging solutions.

An FDA-registered pharmaceutical repackaging

partner, Shamrock Medical is the right choice for

healthcare customers looking to improve their

patient safety, maximize limited resources and cost-

efficiency. With unmatched industry expertise and

quality processes, we deliver superior products and

service to our customers at cost-effective rates.

Outsourcing the right wayPartnering with us not only supports a commitment

to patient safety and Joint Commission standards,

especially with the move toward bedside scanning

in healthcare, but we also help improve the use

of already limited resources. We understand the

complexity of the current healthcare environment

and how it continually asks health organizations to

do more with less – all while upholding the highest

standards for safety and quality.

And since drug repackaging is most likely not a core

competency of your organization, yet an important

and necessary endeavor, outsourcing it to the

experts makes complete business sense. You avoid

the investment of equipment and space and allow

staff to stay focused where their energy is most

needed. We give you expertise you can trust and

a selection of customizable solutions that ensure

medication is the right size, right packaging and

right dose for you and your patients – all making

Shamrock Medical the right choice.

Right size.

“Partnering with Shamrock Medical continues

to be a smart investment in patient safety.”

– Director of Pharmacy at a 300-bed hospital




Customized solutions for you and your patientsYour organization is currently repackaging drugs.

Whether you are scanning at the bedside or have

plans to in the future, Shamrock Medical can help

you improve your process, increasing patient safety

as well as efficiency in operations and spending.

That’s because working with us means:

• No facility set-up issues

• No capital investment

• No equipment maintenance

• No employee training or retraining

• No cleaning

• No noise

• No interface or system issues

• No pharmacist time required to check drugs

We have multiple state-of-the-art, climate-monitored

repackaging facilities ready to repackage your

facility’s drugs in full-labeled and bar-coded unit-dose

medications as required by patient safety standards.

We ensure a quality repackaged product for the

following forms of pharmaceuticals:

• Liquids

• Tablets

• Capsules

• Powders

• Scheduled drugs

• Refrigerated products

• Cytotoxic drugs

• Light resistant items

• Robot compatible

1.Customer establishes contract with Shamrock Medical. Customization requirements discussed.

2.Customer sets up a Bill To – Ship To account with wholesaler to send products for repackaging directly to Shamrock Medical.

3.Customer orders products in bulk using its existing GPO contracts.

4.

Products arrive at Shamrock Medical and begin our comprehensive quality-assurance process, including repackaging into unit-dose pharmaceuticals according to customer specifications.

5. Order shipped to customer using UPS/FedEx.

6.Customer receives repackaged drugs for immediate integration into facility’s systems.

Getting started: How it works

Call 740.657.6000 today to customize your drug repackaging solution.




We’ll work with you to customize your medication’s packaging, labeling and bar-coding so that products seamlessly integrate into your facility’s current processes.

Custom packaging: Comparable to

commercial drug repackaging, options include: cups,

oral syringes, pouches, blister packs, powders and

bingo cards. Also available are over-bagging and

robot-compatible options.

Custom labeling: The FDA requires

repackaged products to include the following

information on each unit-dose medication: NDC

number, generic drug name, brand name (if

applicable), strength, SMSG lot number, “Use

By” date, manufacturer and repackage facility.

Shamrock Medical adheres to these mandates and

takes into consideration product space or software

restrictions. We also provide TALLman lettering.

Custom bar-coding: Shamrock Medical

makes it easier to meet JCAHO requirements for

patient safety by selecting a bar-coding solution

that integrates into your existing procedures.

Choose from Linear 128A, Linear 128C,

Datamatrix, Aztec and Robot-Compatible.

Right packaging.

“Outsourcing medications to a third-party

provider has been a smart business decision

for our hospital. It has freed up personnel

who previously were required to perform

quality checks on repackaged products.”

– Purchasing Manager of a healthcare facility




Right dose.

“We’ve found that receiving ready-to-dispense

pharmaceuticals, clearly labeled and with bar

code, has reduced our hospital’s number of

medication errors. We trust that outsourcing

this practice to a third-party supplier who

focuses solely on drug repackaging and uses

a comprehensive quality process is superior to

having our people do it in-house in addition

to their many other responsibilities.”

– Purchasing Manager at a 250-bed hospital

Unmatched products & process With many years in the healthcare industry,

specifically in pharmacy, Shamrock Medical

understands customers rely on us to ensure each

pharmaceutical repackaged meets the highest

standards for quality and safety. That’s why we go

to the extent of sharing in detail the comprehensive

process products undergo to ensure accuracy,

quality and, above all, safety for the patient.

Informing customers of our investment in state-of-

the-art repackaging equipment and computerized

technology that enables us to monitor procedures

and eliminate human error isn’t just about making

us sound good – it’s about making you feel

confident about our partnership.

Shamrock Medical breaks its quality repackaging

process into six stages, each of which includes

multiple accuracy checks performed by advanced

computer software and our experienced

pharmacists and trained repackaging staff.

Receiving.Customer product orders sent directly from the

wholesaler to Shamrock Medical.

Reconciling.Orders reconciled with their wholesaler invoice to

identify any order/receipt discrepancies.

Staging.Products stored in individual containers and sorted to

prepare for repackaging.

Repackaging.Products repackaged at designated stations

determined by their drug form and customized

specifications.

Reconstructing.Samples tested from each run of repackaged

products, validating the package, label accuracy and

working bar code.

Shipping.Repackaged drugs boxed for shipment to customer.




Industry compliance: Licenses and RegistrationsShamrock Medical’s repackaging facilities

and processes are compliant with applicable

federal and state regulations and guidelines and

licensing requirements.

Repackaging services are performed in compliance with:

• Current Good Manufacturing Practices (CGMP)

• Applicable sections of the United States

Pharmacopeia (USP)

• Applicable sections of the Code of Federal

Regulations Title 21 (21CFR)

Our Ohio facility is:• Registered with the Food and Drug

Administration (FDA) as a drug repackager

• Licensed by the Drug Enforcement

Administration (DEA)

• Licensed by the following state agencies:

– Georgia Board of Pharmacy

– Kentucky Board of Pharmacy

– Louisiana Board of Pharmacy

– Michigan Board of Pharmacy

– Minnesota Board of Pharmacy

– New Hampshire Board of Pharmacy

– Ohio Board of Pharmacy

– Oregon Board of Pharmacy

– Texas Department of State Health Services

– Virginia Board of Pharmacy

– West Virginia Board of Pharmacy

Our Massachusetts facility is:• Registered with the Food and Drug

Administration (FDA) as a drug repackager

• Licensed by the Drug Enforcement

Administration (DEA)

• Licensed by the following state agencies:

– Maine Board of Pharmacy

– Massachusetts Board of Pharmacy

– Massachusetts Department of Public Health

– New Hampshire Board of Pharmacy

– New Jersey Department of Health and

Senior Services

– New York State Board of Pharmacy

– Rhode Island Board of Pharmacy

– Virginia Board of Pharmacy

Both facilities are approved for business in the following states*:• Connecticut • Pennsylvania • Wisconsin

* Licensure not required for out-of-state repackagers in these states




Ask us: FAQs What is the turnaround time once Shamrock

Medical receives my order?

Shamrock Medical’s goal is to process and ship

repackaged products within 48 hours of receiving

an order. Transit time to customer once shipped can

vary, but delivery is usually the day after it’s shipped

by Shamrock Medical.

What expiration date is used on the

repackaged product?

Shamrock Medical complies with United States

Pharmacopeia Chapter 1146 regarding expiration

dating. Shamrock Medical’s repackaged products

have a “use by” date that is the earlier of either:

• one (1) year from the date of repackaging, or

• the expiration date on the manufacturer’s

original container

What lot number is used on the

repackaged product?

Shamrock Medical is required to assign its own

lot number for each lot of repackaged products.

Shamrock Medical records the manufacturer’s lot

number and electronically cross-references it to the

Shamrock Medical lot number.

How do I place an order with Shamrock Medical?

Once a repackaging agreement has been executed,

Shamrock Medical will work with you and your

wholesaler to establish a Bill To/Ship To account.

This will allow you to place orders with your

wholesaler but have them delivered to Shamrock

Medical. We will then work with you about how

you want the product repackaged. It is simple and

effective. You can also send products in your inventory

and from your facility directly to Shamrock Medical.

Do you keep a reserve sample?

Yes, Shamrock Medical is required by federal

regulations to keep a sample of each product

we repackage.

Right choice.

“Since working with Shamrock Medical,

we have seen the benefits of added safety

and efficiency. Not only do we get FDA-

approved packaging and up-to-date recall

information, but they give us a detailed

order history to help eliminate drug waste.”

– Director of Pharmacy at a 200-bed hospital




Is there a minimum order?

Yes, our minimum order is $125. We work with you

to establish the most efficient order quantities.

What bar code format can I have printed on

my repackaged products?

Shamrock Medical has the ability to print linear

(128A and 128C), two-dimensional (2D) and robot-

compatible barcode formats on our repackaged

products. The most common 2D barcodes

(Datamatrix and Aztec) can be customized to

meet your facility’s bedside scanning needs. Other

barcode formats are available. Contact Shamrock

Medical to discuss your specific needs.

How does Shamrock Medical charge for its

repackaging services?

Shamrock Medical charges for its repackaging services

on a “per dose” basis. This ensures that our customers

only pay for the products we repackage for them.

Cost per dose varies depending on the product type,

package type and other factors. Contact Shamrock

Medical for a confidential price list.

Can I still use my existing wholesaler and

GPO contracts?

Yes, Shamrock Medical will work with you and your

wholesaler to establish a Bill To/Ship To account. You

place your orders to be repackaged by Shamrock on

this account. The drugs are delivered to Shamrock

Medical but billed to you. Since this account is a “sub-

account” of your main wholesaler account, you can

still take advantage of buying group contract pricing.

How do my drug orders get to

Shamrock Medical?

Customers establish a Bill To/Ship To account with

wholesalers so they may ship directly to us. Schedule II

narcotics are an exception, and need to be shipped to

Shamrock Medical directly from the customer with the

proper DEA form 222.

How does Shamrock Medical send me the

repackaged products?

Shamrock Medical usually ships your repackaged

products to you via UPS Ground or FedEx. Customers

can receive an email when their package is shipped

by Shamrock and another email when it is received

by their facility. In most cases, our customers receive

the products the day after we ship them.

Can I send products directly to Shamrock?

Yes, you can ship any item in your inventory to be

repackaged. Shamrock Medical can only accept

unopened bottles and packages. Please do not send

opened bottles.

Can I try Shamrock Medical’s repackaging services

before making a long-term commitment?

Yes, Shamrock Medical welcomes the opportunity to

demonstrate our quality and customer service to new

customers. We will enter into a short-term (90-180

days) repackaging agreement with new customers

so they can evaluate our service. This trial agreement

allows the customer to send Shamrock Medical

whatever products, in whatever quantities, they feel

are necessary for a thorough evaluation of Shamrock

Medical’s services. The trial period can then lead into

a longer term repackaging relationship.

Who pays for shipping charges?

The client is billed for all shipping charges.

Are Shamrock Medical’s facilities licensed?

Yes, Shamrock Medical’s repackaging facilities

are registered with the FDA, licensed by the DEA

and are licensed by the applicable state Boards of

Pharmacy and other state agencies.




What industry standards does Shamrock

Medical use when repackaging?

Shamrock Medical repackages using Current Good

Manufacturing Practices (CGMP). We also comply

with applicable Food and Drug Administration (FDA)

regulations and Industry Guidances; applicable

sections of the Code of Federal Regulations Title 21

(21CFR); and applicable sections of the United States

Pharmacopeia (USP).

Are there any drugs that Shamrock Medical

cannot repackage?

Yes, there are a few drugs that Shamrock Medical

does not repackage (examples include: penicillin,

cephalosporins, nitroglycerin). We also do not

repackage any product that is labeled “do not

repackage” by the manufacturer.

What about drug recalls?

Shamrock Medical is notified daily by the FDA

of any drug recalls. We cross-reference the

recalled manufacturer lots with our assigned

repackaged lot numbers and notify the affected

customers immediately.

Can Shamrock Medical repackage light

sensitive drugs?

Yes, Shamrock Medical can repackage light sensitive

medications with materials that meet or exceed the

standards stated in chapter 661 of the USP.

Can Shamrock Medical repackage

refrigerated items?

Yes, Shamrock Medical repackages refrigerated items,

stores them in climate monitored refrigerators and

ships them in insulated boxes with cold packs.

Can Shamrock Medical repackage

cytotoxic items?

Yes, Shamrock Medical repackages cytotoxic drugs.

We have specific procedures to handle, repackage

and ship cytotoxic medications.

Can Shamrock Medical repackage scheduled

drugs including C-IIs?

Yes, all Shamrock Medical repackaging facilities are

licensed by the DEA for Schedule II, III, IV and V drugs.

Can Shamrock Medical repackage products in

ways that aren’t listed on the website?

Yes, Shamrock Medical is ready to work with our

customers to develop customized repackaging

solutions for their facility’s specific needs. Please

contact our repackaging facility or email us at

[email protected] with your request.

For additional questions not answered here, call us at 740.657.6000 or email [email protected].




The experts in drug repackaging: Leadership teamBacked by years of industry experience and a

commitment to excellence, the management team

at Shamrock Medical ensures efficient and cost-

effective repackaging solutions for its clients. The

company’s leaders along with dedicated staff

contribute to Shamrock Medical’s expert status in

drug repackaging. Their personal commitment to

quality and innovative technology delivers products

customized for optimum accuracy and safety, plus

provides superior customer service.

Jim Martin, R.Ph.

President

Jim founded Shamrock Medical, a division of The

Shamrock Companies, Inc., in February 2005 as the

premier, outsourced repackager of pharmaceuticals

for hospital pharmacies. He is responsible for the

strategic vision, discovering and implementing new

technologies and working closely with customers to

ensure the highest level of satisfaction.

Notable Experience: Jim has held multiple

executive level positions at companies with strong

ties in the healthcare industry, including Cardinal

Health, RESTAT, an online insurance claims process

company, and D.P. Hamacher and Associates, now

Hamacher Resource Group. His leadership experience

combined with his role as Executive Vice President of

the Michigan Pharmacists Association and a former

multi-site retail pharmacy owner make for a valuable

perspective on drug repackaging.

Mark Leney, R.Ph.

General Manager, East Taunton, Mass. repackaging facility

A registered pharmacist, former business owner and

respected member of the pharmacy community,

Mark brings strategic business expertise and

management skills to Shamrock Medical.

Notable Experience: In 1987, Mark co-founded

PHARMACISTS: prn, Inc., a temporary service and

placement agency that specialized in pharmacy. In

1999, he sold the business to Cardinal Health and

continued in senior management to ensure the

long-term growth and success of the business.




To customize your facility’s solution for

drug repackaging with the experts, contact

Shamrock Medical today at 740.657.6000.

And to learn more about our capabilities, visit us at www.shamrock-medical.com.

741 Radio Drive Lewis Center, OH 43035 p. 740.657.6000 • f. 740.657.6006

250 Revolutionary Drive - Suite 200, East Taunton, MA 02718 p. 508.824.1544 • f. 508.824.1655

CO

NTA

CT

States in which our OH facility is licensed to repackage

States in which our MA facility is licensed to repackage

States in which both facilities are licensed or approved to repackage

KEY

Lewis Center, OH

East Taunton, MA

Repackaging Facilities

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