Frequently Asked Questions
Questions About PenCol Specialty Pharmacy
WHERE IS PENCOL SPECIALTY PHARMACY LOCATED?
1325 South Colorado Boulevard
Suite B-024
Denver, CO 80222
Note: Entrance to pharmacy is from the exterior of the building on the opposite side from Colorado Blvd.
WHAT ARE PENCOL SPECIALTY PHARMACY’S HOURS OF OPERATION?
Mon. Fri. 9am-6pm
Sat. Sun. Closed
HOW CAN I FILL MY PRESCRIPTION AT PENCOL SPECIALTY PHARMACY?
The doctor can phone or fax the prescription, or the patient can bring the prescription to the pharmacy. The doctor may also eprescribe the prescription.
WHICH STATES DOES PENCOL SPECIALTY PHARMACY SERVE?
PenCol Specialty Pharmacy provides custom compounded medications in a growing number of states across the United States.
• AZ
• CO
• DE
• FL
• GA
• IL
• KY
• NM
• NY
• PA
• RI
• WI
• WY
ARE PENCOL SPECIALTY PHARMACY PRESCRIPTIONS COVERED BY INSURANCE?
PenCol Specialty Pharmacy does not directly bill insurers. Depending on your insurance plan, you may be reimbursed by sending in a claim form. Many insurance companies cover compounded prescriptions. However, we suggest that you contact your insurance company to learn about your specific coverage. We can provide you with an insurance claim form that you may send to your carrier upon request.
WHAT MEDICAL DISCIPLINES DOES PENCOL SPECIALTY PHARMACY SPECIALIZE IN?
PenCol Specialty Pharmacy creates several formularies for many different specialty medicine uses, including but not limited to:
• Urology
• Veterinary
• Bioidentical Hormone Replacement Therapy
• Women’s Health
• Men’s Health
• Dermatology
• Fertility
• Hospice/Palliative
• Pain Management (Topical non-opioid pain creams and gels)
• Pediatric
• Wound Care
• Sports
WHAT DOSAGE FORMS DOES PENCOL SPECIALTY PHARMACY OFFER?
• Creams, gels, and ointments
• Oral solutions and suspensions
• Tablets, and capsules
• Lollipops and lozenges (troches)
• Sprays
• Suppositories
• Balms
• Powders
• Animal treats
• Injectables (for sterile)
CAN PENCOL SPECIALTY PHARMACY SHIP MY PRESCRIPTION TO ME?
Yes! We ship our compounded prescriptions via FedEx for only $10 for non-refrigerated and $25 refrigerated.
HOW OFTEN IS THE STAFF AT PENCOL SPECIALTY PHARMACY TRAINED IN NON-STERILE AND STERILE PROCEDURES AND REGULATIONS?
All our pharmacists and technicians are formally trained in non-sterile preparations once per year and in sterile preparations every six months.
WHAT INDUSTRY RECOGNIZED ACCREDITATIONS DOES PENCOL SPECIALTY PHARMACY HOLD?
PenCol Specialty Pharmacy is accredited with the Pharmacy Compounding Accreditation Board (PCAB), a sub-specialty administered by the Accreditation Commission for Health Care (ACHC). PCAB’s onsite assessment conducted by an independent compounding expert and annual verification process ensures our compliance with both sterile and non-sterile compounding procedures set forth by USP <795> and USP <797>, which define best practices in compounding.
PenColrx.com is certified by LegitScript. LegitScript’s Healthcare Certification ensures we meet standards for legality, safety and transparency as a pharmacy. LegitScript verification is recognized by physicians and patients around the world to determine companies to trust.
WHAT IS COMPOUNDING, AND WHY IS IT NECESSARY?
Compounding is the creation of a pharmaceutical preparation—a drug—by a licensed pharmacist to meet the unique needs of an individual patient (either human or animal) when a commercially available drug does not meet those needs. A patient may not be able to tolerate the commercially available drug, the exact preparation needed may not be commercially available, or a patient may require a drug that is currently in shortage or discontinued. The U.S. Pharmacopeia Convention (USP) formally defines compounding as “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice.”
Following are a few examples of how a compounding pharmacist can customize medications based upon a doctor’s prescription to meet a patient’s needs:
• Customize strength or dosage.
• Flavor a medication (to make it more palatable for a child or a pet).
• Reformulate the drug to exclude an unwanted, nonessential ingredients, such as lactose, dyes, or unwanted fillers.
Compounding pharmacists can put drugs into specially flavored liquids, topical creams, transdermal gels, suppositories, or other dosage forms suitable for patients’ unique needs. Compounding does not include making copies of commercially available drug products, as this is not allowed by law.
HOW IS PHARMACEUTICAL COMPOUNDING DIFFERENT FROM DRUG MANUFACTURING?
Traditional compounding is the preparation of a medication to meet the prescriber’s exact specifications and to be dispensed directly to the patient, pursuant to a valid prescription for that patient. Pharmaceutical compounding is performed or supervised by a pharmacist licensed by a state board of pharmacy (see question below on legal oversight of compounding versus manufacturing). Manufacturing is the mass production of drug products that have been approved by the Food and Drug Administration (FDA).
These products are sold to pharmacies, health care practitioners, or others who are authorized under state and federal law to resell them.
WHAT IS A COMPOUNDING PHARMACY?
While most pharmacies offer some level of compounding, most compounding is done in pharmacies that have made the investment in equipment and training to do so safely and efficiently. The preparations offered by these compounding pharmacies can be nonsterile (ointments, creams, liquids, or capsules that are used in areas of the body where absolute sterility is not necessary) or sterile (usually intended for the eye, or injection into body tissues or the blood).
All licensed pharmacists learn during their training and education to perform basic compounding. In addition, most pharmacies have some compounding tools, such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, balances for weighing solids, spatulas for mixing materials, and ointment slabs on which to work. With such tools and through applying their knowledge, all pharmacists routinely prepare nonsterile compounded preparations when requested by prescribers.
Of the approximately 56,000 community-based pharmacies in the United States, about 7,500 pharmacies specialize in compounding services. This means the pharmacists in those facilities spend most or all of their time compounding special preparations for patients. Preparations made in these pharmacies are more likely to include both sterile and nonsterile dosage forms. Compounding also takes place in hospital pharmacies and at other health care facilities.
WHO REGULATES COMPOUNDING PHARMACIES? DO COMPOUNDING PHARMACIES FOLLOW THE SAME REGULATIONS AS DRUG MANUFACTURERS? WHY OR WHY NOT?
The practice of compounding is regulated by state boards of pharmacy. Community and hospital compounding pharmacists are allowed exemptions to the Federal Food, Drug, and Cosmetic Act of 1938 if they comply with the regulations outlined in Section 503A. All pharmacists and pharmacies engaged in compounding are subject to oversight by both federal and state authorities.
Pharmacists engaged in compounding are expected to follow applicable standards and regulations for the types of preparations that are compounded. FDA has oversight for the integrity and safety of the drugs (called Active Pharmaceutical Ingredients, or APIs, by FDA) used in compounded preparations. The Drug Enforcement Administration (DEA) has oversight for any controlled substances used in the preparation of compounded medications. Controlled substances include narcotics such as hydrocodone, amphetamines, and similar drugs, and drugs such as those used for anxiety and sleep disorders.
In addition, the United States Pharmacopeial (USP) Convention issues standards that apply to compounding. This private, nonprofit organization defines the chemical purity of drugs and also issues practice standards. USP develops standards for the identity, quality, strength, and purity of medicines, dietary supplements, and food ingredients that may be used in compounding preparations. These standards in particular are relevant to compounding pharmacists.
All licensed pharmacists learn during their training and education to perform basic compounding. In addition, most pharmacies have some compounding tools, such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, balances for weighing solids, spatulas for mixing materials, and ointment slabs on which to work. With such tools and through applying their knowledge, all pharmacists routinely prepare nonsterile compounded preparations when requested by prescribers.
Of the approximately 56,000 community-based pharmacies in the United States, about 7,500 pharmacies specialize in compounding services. This means the pharmacists in those facilities spend most or all of their time compounding special preparations for patients. Preparations made in these pharmacies are more likely to include both sterile and nonsterile dosage forms. Compounding also takes place in hospital pharmacies and at other health care facilities.
USP General Chapter <797> is a national standard for the process, testing, and verification of any compounded sterile preparations. It provides guidance on preventing microbial contamination and other variances in compounded sterile preparations, regardless of setting (e.g., hospitals, community pharmacies) or who is performing the compounding (pharmacists, nurses, pharmacy technicians, or others).
USP General Chapter <795> provides similar guidance for nonsterile preparations that are compounded in health care settings. It describes categories of compounding (simple, moderate, complex), defines concepts such as beyond-use date and stability, and provides criteria for compounding pharmacists to follow in preparing various drug preparations.
USP General Chapter <800> is a new standard developed by USP that establishes practice and quality standards of hazardous drugs to minimize the exposure to hazardous drugs within health care settings. This standard aims to promote worker safety (pharmacists, pharmacy technicians, veterinarians, veterinary technicians, and many others), patient safety, and environmental protection. This standard was published on February 1, 2016, but will not be officially implemented until July 1, 2018. The current list of hazardous drugs is available from the National Institute for Occupational Safety and Health (NIOSH).
Compliance with these and other USP guidelines is considered the minimum standard of practice in pharmacy.
Pharmacy Compounding Accreditation
Pharmacy Compounding Accreditation is a service of the Accreditation Council for Health Care (ACHC) that assesses the nonsterile and sterile pharmacy compounding process as defined by a specific set of standards that concentrate on the quality and consistency of medications produced.
HOW ARE COMPOUNDED MEDICATIONS CUSTOMIZED?
With a physician’s prescription, a compounding pharmacist can adjust dosage for strength or quantity, change the medication’s form (e.g., create a liquid for a child or adult who cannot swallow a pill), formulate the medication to exclude non-essential ingredients (i.e.. dyes, gluten, sugar, lactose, preservatives), or flavor certain medications for adherence to taking the medication.
WHO CAN WRITE A PRESCRIPTION FOR COMPOUNDED MEDICATIONS?
Prescriptions can come from Medical Doctors (MD), Doctors of Osteopathic Medicine (DO), Doctor of Dental Surgery (DDS), Naturopathic Doctors (ND), Physician Assistants (PA), and Advanced Practice Registered Nurses (APRN). Some doctors have limitations on what may be prescribed and these limitations may vary from state to state. Prescriptions to PenCol Specialty Pharmacy can be submitted by healthcare professionals by phone, fax or electronic eprescriptions.
HOW WOULD PATIENTS KNOW IF THEIR MEDICATION IS COMPOUNDED? KNOWING THAT, SHOULD THEY TAKE ANY PRECAUTIONS, OR DO ANYTHING DIFFERENTLY?
Ask. A patient can receive compounded drugs from a typical community pharmacy or a specialty compounding pharmacy, or compounded drugs can be administered by doctors or other health professionals in clinics or medical offices. Patients should ask the person administering a medication or the pharmacist dispensing a prescription whether it was prepared in a compounding pharmacy or manufactured by a drug company. A widely accepted standard of practice is to label all compounded preparations with information stating the medication has been “compounded.”
If a prescription calls for a compounded drug, patients can ask whether the compounding pharmacy is accredited. Lists of accredited compounding pharmacies are organized by state on the Pharmacy Compounding Accreditation Board’s (PCAB) website.
DOES A COMPOUNDING PHARMACIST HAVE SPECIAL TRAINING?
Compounding is a central activity to the practice of pharmacy. Pharmacists are taught in pharmacy school how to properly compound medications, and many states test pharmacists’ compounding knowledge and skills before issuing them a license.
Pharmacists who practice in the 7,500 pharmacies that specialize in compounding services have generally had advanced training in compounding after they graduated from pharmacy school. No state currently requires a particular type of training, and no nationally recognized specialty exists for pharmaceutical compounding. Specialized training in pharmacy compounding processes is available through several of the active pharmaceutical ingredient (API) suppliers serving the needs of the compounding pharmacy community.
ARE COMPOUNDED PRESCRIPTIONS SAFE?
The Food and Drug Administration (FDA) recognizes that the practice of pharmacy compounding is an alternative for patients who require medication that is not commercially available, or not available due to drug shortages. To ensure patient safety, all compounded prescriptions must be prescribed by a licensed provider and created by a licensed pharmacist. In addition, the products and supplies used by PenCol Specialty Pharmacy come from FDA-registered and inspected wholesaler facilities.
Pharmacists who practice in the 7,500 pharmacies that specialize in compounding services have generally had advanced training in compounding after they graduated from pharmacy school. No state currently requires a particular type of training, and no nationally recognized specialty exists for pharmaceutical compounding. Specialized training in pharmacy compounding processes is available through several of the active pharmaceutical ingredient (API) suppliers serving the needs of the compounding pharmacy community.
WHEN IS A COMPOUNDING PHARMACY NECESSARY?
A health care provider will prescribe a compounded drug only when commercially available drug products do not meet your needs. If you do not understand why you have been prescribed a special formulation, ask your prescriber. If you are concerned about taking a compounded drug and you and your prescriber agree that you can tolerate the commercially available drug, you may also ask if there is any evidence that your outcome will be better on the compounded formulation.
I HAVE A COMPOUNDED MEDICATION THAT IS PAST ITS “DO NOT USE BEYOND” DATE. CAN I STILL USE IT?
You should not use a compounded prescription beyond the labeled “Do Not Use Beyond” use date. Please call us at (303) 388-3613 to speak with a pharmacist for any additional questions.
WHAT IS THE DIFFERENCE BETWEEN STERILE AND NON-STERILE COMPOUNDING?
In the compounding pharmacy industry, there are specific definitions, regulations, and licensure that differ between running a sterile compounding laboratory or facility versus a non-sterile compounding laboratory or facility.
Sterile compounding follows strict standards established by the United States Pharmacopeia (USP) General Chapter <797> and is used when there is a high risk of infection, as sterile compounded medications are typically intended to be used as injections, intravenous (IV) infusions, or ophthalmic sterile compounds for eye drops. Medications like these need to be carefully prepared in a separate sterile clean-room, an environment free from viruses, bacteria, or any other infectious microorganisms.
PenCol Specialty Pharmacy offers a select catalog of sterile compounds that have undergone the required method suitability and container closure testing. We specialize in bimix, trimix, and quadmix for erectile dysfunction, atropine eye drops, and methylcobalamin (Vitamin B) injections.
Non-sterile compounding is more common and while these drugs are not prepared in a sterile clean-room, they are made with high standards and strict guidelines as established by the United States Pharmacopeia (USP) General Chapter <795>. Non-sterile compounding utilizes a clean environment where equipment, surfaces and materials are sanitized. Non-sterile compound medications include the production of solutions, suspensions, ointments, creams, gels, powders, suppositories, capsules, troches, dissolvable forms, and tablets, and are typically taken orally or used topically.
