Canadian Apothecary

Canadian Apothecary Pharmacy specializes in compounding, prescriptions, and natural medicines. Call 519-439-4100.

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Canadian Apothecary

Canadian Apothecary Pharmacy specializes in compounding, prescriptions, and natural medicines. Call 519-439-4100.

Signed in as:

filler@godaddy.com

  • Home
  • Our Services
    • Topical Pain Compounds
    • Dermatological Compounds
    • Pediatric Compounds
    • Podiatry Chiropody
    • Veterinary Compounding
    • Erectile Disfunction
    • Thyroid Support
    • FAQ?
  • Patients
    • Patient Profiles
    • New Prescriptions
    • Refill Prescriptions
    • Member's Access Only
  • Health Professionals
    • Physicians
    • Naturalpath / Homeopath
    • Alternative Practicioners
    • Dentists
    • Midwives
  • Veterinarians

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Frequently Asked Questions Pharmaceutical About Compounding

FAQ

 



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 ingredient, such as lactose, gluten, or a dye to  which a patient is allergic.
  • Change the form of the medication for  patients who, for example, have difficulty swallowing or experience  stomach upset when taking oral medication.

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.

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 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.  
 

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.
 

Where is more information about compounding available?

APhA has made available on this website the introductory chapter of a leading book it publishes on compounding pharmacy. Author Loyd V.  Allen Jr., a recognized expert in pharmaceutical compounding and editor  of the International Journal of Pharmaceutical Compounding, provides  detailed information about many topics, including those presented in  these FAQs.

For additional information about compounding pharmacy, contact IACP,  PCAB, USP, the National Association of Boards of Pharmacy (NABP) or the  appropriate state board of pharmacy.

If you are interested in information on new regulations, news  stories, and practice standards in compounding pharmacy, these are  available on APhA’s “Just the Facts” page. The FDA and CDC websites  provide up-to-date information, lists of affected facilities and states,  treatment guidelines, FAQ statements and other resources to assist  health care providers and the public in addressing this issue.

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