pharmaceutical laws and regulations

1. Ch 9. Pharmaceutical Laws and
Regulations
Instructor’s Name: Berhanemeskel W/Gerima
Email: aberhaneth@gmail.com
Cell Phone: +251912024213
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Introduction to Pharmacy Law & Ethics
(Phar 4173)

2. 9. Pharmaceutical Laws and Regulations
9.1. Pharmaceutical legal systems
9.2. Drug nomenclature
9.3. Labeling and packaging requirements of pharmaceuticals
9.4. Administration/quality assurance
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3. 9.1. Pharmaceutical legal systems
• Practice of pharmacy–governed by series of laws,
regulations, and rules enforced by
– federal, state, local government;
– institutions and pharmacy management
• Pharmaceutical legal systems constitutes:
– Legislative legal system
– Executive legal system and
– Judicial legal system
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4. 9.1. Pharmaceutical legal systems
Laws
• A law is a rule that is passed and enforced by the legislative branch of
government.
• Law is a collection of rules imposed by authority
• The law offers a minimum level of acceptable standards.
• The legislature sees to the passing and enforcement of laws for the protection of
the public.
• Violation to laws may result in damages, fines, probation, loss of licensure or
incarceration.
 Law systems are often based on ethical or religious principles and are enforced
by the police and criminal justice systems such as the courts
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5. 9.1. Pharmaceutical legal systems
Laws
 Law systems are often based on ethical or religious principles and
are enforced by the police and criminal justice systems such as the
courts
• Sources of law
– Legislative branch – passes laws
– Executive branch – implements laws
– Judicial branch – interprets laws
– Administrative branch- Rulemaking, investigative, adjudicatory
and enforcement role
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6. 9.1. Pharmaceutical legal systems
Regulations
• A regulation is a written rule and procedure that exists to carry
out a law.
• Regulations include drug approval processes, distribution and
dispensing allowances.
• Regulations can also affect pharmacy practice like, licensure,
registration, and certification requirements.
• When there is a conflict between a state and a federal law
or regulation, the more stringent law or
regulation always applies.
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7. 9.1. Pharmaceutical legal systems
Function of law:
• defines relationships among members of society
• allocates authority and define who may exercise physical
coercion
• disposition of trouble cases as they arise
• redefines relations between individuals and groups
Classification of Law
• Criminal Law
• Civil Law
• Administrative Law
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8. 9.1. Pharmaceutical legal systems
 In Ethiopia, major categories of law apply,
 Criminal law
 Civil law
 Administrative law
 Healthcare is governed by legislation intended to
 protect the public and prevent harm and
 advanced practitioners require a knowledge of relevant legislation and
 their responsibilities to the public and their employer.
Pharmacy Law
• It is a body of law concerning manufacturing of drugs, drug distribution, drug
therapy, practice of pharmacy and other issues related with medication use
• It is majorly intended to protect peoples from harm because of medications
and services.
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9. 9.1. Pharmaceutical legal systems
Civil Laws
• Civil law is given to areas of the law that concern citizens and wrongs they may
commit against each.
• Relates to disputes between two or more private parties
• Object is to compensate the injured party
• Penalties include damage awards, enforcement of contracts, or
injunctions against action
• Tried before a court
• Covers issues such as:
– Contracts
– Tort: a wrong against another
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10. Administrative law
• Administrative law covers the procedures that are put in place for ensuring that
the decision-making processes and systems are regulated.
• Shortfalls in relation to administrative justice are dealt with through tribunals
and inquiries.
• It is unlikely that many pharmacists would become involved in this aspect of
legislation;
• however, it does have an impact on the way the professional regulator is set up
and how it deals with misbehavior of members.
9.1. Pharmaceutical legal systems
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11. Administrative law
• Investigations of violations of rules or regulation made by administrative agencies
• Directly affects only those individuals subject to the agency’s jurisdiction
• Object is to correct professional or business behavior, and/or to remove a person from a
profession if he or she poses a danger to the public
• Involves hearings before the agency
• Results in payments of fines and/or probation, suspension, or revocation of license or
other permit
• May be appealed to a court
9.1. Pharmaceutical legal systems
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12. 9.2. Drug nomenclature
• A marketed drug has three names: a chemical name, a generic
name, and a brand name.
Chemical Name
• It is given when a new chemical entity (NCE) is developed.
• It is a scientific name based on the compound's chemical structure
and is almost never used to identify the drug in a clinical or
marketing situation.
• Often, the name is long and difficult to pronounce, and, since it has
numbers,
– the number in the name might become confused with the numbers in the
prescription.
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13. 9.2. Drug nomenclature
The generic name (or non-proprietary name)
• Is granted by the USAN Council and is commonly used to identify a drug during
its useful clinical lifetime.
• The generic name does not belong to the company that discovers the drug (or
owns the patent).
• Once the patent lifetime is expired, any company may market the drug under
the generic name.
• The generic name must be screened to assure that it does not resemble any
other generic or brand name.
• The generic name must also be appropriate for the class of drug.
Brand name (trademark)
• The company that patents the drug creates the brand name (trademark). This
name identifies the drug during the 17 years that the company has exclusive
rights to make, sell, and use it under patent law.
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14. 9.3. Labeling and packaging requirements of pharmaceuticals
• Any producer, importer, distributor, retailer or health
institution of medicine shall not supply it to the market or
distribute it otherwise unless it is duly packed and labeled
• The label of any medicine shall be written either
–in the Amharic or
–English language
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15. Importance of Packaging and Labeling in Pharmaceutical Industry
• The products manufactured to resolve health issues would be of no use if they
are not packed and labeled appropriately.
• It is vital for any pharma product that it remains in its original form and
maintains its quality until it reaches the hands of end users. Packaging and
labeling are two individual activities that have to be performed as per
their significance.
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16. LABELING
• The U.S. Federal Food, Drug and Cosmetic Act (FFDCA) defines "labeling" as all
labels and other written, printed, or graphic matter upon any article or any of its
containers or wrappers, or accompanying such article.
• The term 'accompanying' is interpreted liberally to mean more than physical
association with the product.
– It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites,
etc.
• Drug labeling refers to all of the printed information that accompanies a drug,
including the label, the wrapping and the package insert.
• one of the crucial factors that determines the safety and integrity of the product.
– This operation includes both printing on the carton and leaflets provided individually with the
pharma products.
• The primary purpose of labeling is to make identification of the product clear and
unambiguous.
– It conveys essential information to the patient on the use of the preparation.
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17. Properly Labeling Pharmaceutical Product
1. Labeling Responsibilities
• According to the FDA, all labels printed for use in the pharmaceutical and healthcare industry are required
to be designed and applied so they can remain in place and be read in different environments through
distribution, storage and use.
• The label print must be legible and will remain that way throughout the product’s life span.
Product manufacturers are responsible for complying with content and format requirements.
2. Displaying Product Information
• All types of labeling have content requirements for what types of information and claims can be stated on a
label.
• Checklist of important things to include on a pharmaceutical or healthcare product label:
Official product name
Active and inactive ingredients
Drug Facts table
Purpose and use
Warnings
Directions
Allergic reactions
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18. Properly Labeling Pharmaceutical Product
Additional labelling
1. Batch number
2. “ for animal treatment only” on verterinary prescriptions.
3. Storage conditions
4. Precautions relating to use of products
Ex. “ caution: Flammable” keep away from flame.
“Not to be consumed by mouth”
• Other examples:
DO not swallow
Take X times a day
Put two drops in the affected eye.
For creams and ointments: spread thinly
For pessaries/ suppositories: Gently put on into the vagina/ rectum
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19. 3. Formatting Labels for FDA Approval
• Labels must be designed in the appropriate FDA format for a product’s
classification like OTC medications, oral contraceptives, combination
products, etc.
• Some things to be considered when designing labels for FDA approval:
 Font size and type (must be legible)
 Language (appropriate use of abbreviations, grammar, advertised claims,
etc.)
 Format (organization and appearance of sections like Drug Facts,
warnings, uses, etc.)
 Materials (depending on the nature of the product)
Properly Labeling Pharmaceutical Product
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20. Properly Labeling Pharmaceutical Product
4. Choosing Approved Materials
• Label materials for pharmaceuticals aren’t as stringently regulated as the
packaging/container that will touch the drug product. Label materials can be
made from standard white paper stock to holographic films to shrink
sleeve labels.
• Multi-layer labels (also known as booklet labels) are often used because
pharmaceutical and healthcare products are required to share large amounts
of information. For further product safety, adhesives, coatings and inks must
be “low migration” meaning that little to no substances transfer from the
materials to the drug or device.
5. Controlling Label Quality
• Every label printed should be inspected thoroughly to ensure the information
is consistent and accurate. Industry standards must be met for safety and
liability reasons.
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21. Properly Labeling Pharmaceutical Product
Printing multiple pharmaceutical labels:
• The products should be separated to prevent any mix-ups or switches.
• Product separation can be physical or spatial, or can be completed by
performing press runs at different times to avoid confusion.
Proper control of storage:
• An important consideration, proper storage control is necessary for
preventing any mix-ups or switches when dealing with labels printed
for use in the pharmaceutical industry.
• Labels should be carefully examined to ensure they comply with FDA
standards and specifications.
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22. How should you label a patient's prescribed medication ?
 The label on the patient's medicine should contain the instructions that the
doctor wrote out on the prescription.
 The information on the medicine's dispensing label usually includes:
• patient's name
• doctor's name
• the name and address of the pharmacy that dispensed the medicine
• the date the medicine is dispensed
• the generic & the brand name of the medicine
• the dose the patient should take, how to take it and how often
• the amount of medicine in the container and the dosage strength
• if necessary, any cautions or warning messages that apply to the medicine
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23. 1. All labels must have a patient's info such as:
• (Mr., Mrs., Ms.) not to confuse with the other family members.
• Name & Address of the pharmacy & the date when it was dispensed
2. Must state the Name, Strength, & the Quantity of the medication
dispensed.
3. Products for internal use should have White Label and Red Label for
external use.
4. It is required to indicate the Month and Year after which the product
should not be used such as:
discard after 03-01-16
Detailed Requirements for Labeling a Patient's
prescribed medication
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24. Detailed Requirements for Labeling a Patient's
prescribed medication
5. Warning Labels such as:
Suppository - "For rectal use only, don't swallow."
• Gargles & Mouthwash - "Not to be swallowed."
• Pessaries - "For vaginal use only, don't swallow."
6. Use of Active Verbs such as:
• Take two - NOT - "Two to be taken"
• Use one - NOT - "One to be used"
• Insert one - NOT - "One to be inserted"
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25. Detailed Requirements for Labeling a Patient's
prescribed medication
7. Frequency and Quantity of formulations should be expressed in Words rather than in
Numerals.
× Take 1 cap 2 x a day (misinterpreted)
 Take one capsule two times a day
× Take two three times a day (misinterpreted)
 Take two tablets three times a day.
8. Dosage instruction should be appropriate.
× Never use "Take" if it is NOT for oral route
 Use "Apply"
9. Be prepared to give VERBAL explanation on the label.
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26. Proper Positioning of Label
• Medicine Bottles
• Label should be on the front of a medicine bottle about third
of the way down the container.
• Cartons
• Label should be on the large side of the carton.
• or placed around the carton.
• Ointment Jars/ Tubes
• Label should be placed on the side of the jar or tube.
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27.  Are containers that preserve the quality of a medicine for the stated
shelf life.
 This containers must maintain the safety, stability of the medicine &
protect the product against physical, climatic, chemical & biological
hazards.
• In the pharmaceutical industry it is vital that package selected
adequately preserve the integrity of the product.
• The selection of a package therefore begins with the determination
of the product's physical & chemical characteristics, its protective
needs and marketing requirements.
PACKAGING
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28. PACKAGING
 Materials for packaging SHOULD:
－ protect the product from physical damage
－ protect the product from chemical & contamination
－ protect the product from light & moisture
－ protect the product from environmental condition
－ be FDA approved
 Materials selected should NOT:
－allow product leakage
－ chemically react with the product
－ release components
－ uptake product components
－ be toxic
－ impart odor or taste to the product
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29. 9.4. Administration/Quality Assurance
• Any medicine or raw material or packaging material of a medicine shall meet quality
standards and requirements prescribed in
– the pharmacopoeia issued or adopted by the appropriate organ or,
– where it is not included in such pharmacopoeia, those standards and requirements prescribed
by manufacturing companies and accorded with international or the appropriate organ’s
acceptance.
• Where any medicine lacks the expected use of safety, efficacy and quality for which
its permit is granted , or its risk outweighs its benefit,
– its use shall be banned and its registration shall be revoked.
• Any medicine shall be available for use in accordance with the standard and working
directives to be issued by the executive organ to ensure the appropriate use of
medicine.
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30. 9.4. Administration/Quality Assurance
• Where any medicine lacks the expected use of safety, efficacy and
quality for which its permit is granted , or its risk outweighs its
benefit, its use shall be banned and its registration shall be revoked.
• Any medicine shall be available for use in accordance with the
standard and working directives to be issued by the executive
organ to ensure the appropriate use of medicine.
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31. 10. Laws, Regulations and Directives Pertaining to
Pharmaceutical Services in Ethiopia
Laws and Regulations
– FMHACA. Food, Medicine And Healthcare Administration And Control
Proclamation No. 661/2009
– FMHACA Regulation No 189 2010
– Food Medicine and Healthcare Administration And Control Councils
Of Ministers Regulation No 299/2013
– Requirements & Guidelines For Registration Of Human Drugs
– Institutions Registration And Licensing Council Of Ministers
Regulation Page 8729 Schedule 8735/2015
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32. 10. Laws, Regulations And Directives Pertaining to Pharmaceutical Services in Ethiopia
Directives
– Requirements & Guidelines For Registration Of Human Drugs
– GMP Guideline For Pharmaceutical Products
– Directive For Medicine Manufacturing Establishment 2013
– Small Scale Medicine Establishment Directive 2014
– Pharmaceutical Promotion Directive
– Requirements & Guidelines For Registration Of Human Drugs
– Guidelines For Conducting Clinical Trials In Ethiopia
– Guideline For Registration Of Medicines 2014
– Medicine Retail Outlet Model Directive 2013
– Health Institution Promotion 2014
– Medicine Import, Export & Wholesalers Control Directive
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33. 10. Laws, Regulations And Directives Pertaining to Pharmaceutical Services in Ethiopia
Directives
– Health Professionals Registration and Licensing Directive 2014
– Rate Of Service Fees For Food, Medicine, Health Professional And
Health
– Institutions Registration And Licensing Council Of Ministers
Regulation Page 8729 Schedule 8735/2015
– NPS Prescription Paper Directive 2013
– NPS Control Directive 2013
Etc…
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