Transcript Federal Food, Drug and Cosmetic Act 1938

OTC drugs and
Cosmetic Products
Presented by David Hsu
New Century Company
U.S. Regulatory
Agencies
1.
U.S. Food and Drug Administration (FDA)
2.
U.S. Department of Agriculture (USDA)
3.
Environmental Protection Agency (EPA)
4.
U. S. Customs
5.
The Federal Trade Commission (FTC)
6.
Department of Justice, Civil Division, Office of Consumer
Litigation
7.
State Regulatory Agencies
8.
State and Federal Courts
FOOD AND DRUG
ADMINISTRATION
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FDA is a scientific regulatory agency responsible for
the safety of the nation's domestically produced and
imported foods, cosmetics, drugs, biologics, medical
devices, and radiological products.

FDA is part of the Executive Branch of the United
States Government within the Department of Health
and Human Services (DHHS) and the Public Health
Service (PHS).
Department of Health and Human
Services Food and Drug
Adminstration
Center for Food
Safety and applied
nutrition (CFSAN)
Center for Drug
evaluation and Research
(CDER)
Center for Devices and
Radiological Health
(CDRH)
Others
Registration of Food / Drug
Facilities
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Who must register under the proposal?
Is there a registration fee?
What will happen if facilities fail to register by
December 12, 2003
When can facilities register?
How many facilities are covered by this
proposal?
Establishment & Maintenance of
Records
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Business that manufacture, process, pack,
transport, receive, hold or import food,
drug….
Imports
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Traditional import operations have routinely focused
on procedural mechanisms
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Product sampling
Entry review of documents
Issuance of various notices
Traditional remedies are administrative
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Detentions and Refusals
Exportation or destruction of refused goods
Administrative Detention
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FDA to administratively detain food if the
agency has credible evidence or information that
the food presents a threat to serious adverse
health or death the humans or animals
2005 FDA IMPORT ENTRIES

FDA RELATED ENTRIES ~ 11 Million ~
LA and Long Beach - 30% National Entries
Enforcement Actions
FDA
•REFUSAL
•VOLUNTARY RECALL
•WARNING LETTER
•SEIZURE/ INJUNCTION
•CRIMINAL
PROSECUTION
•REQUEST STATE
•EMBARGO
•ENFORCEMENT
ACTIONS
CBP (CUSTOMS BOARDER PATROL)
•LIQUIDATED
DAMAGE
•BOND INCREASE
•CIVIL PENALTY
•CARGO CONTROL
•SEIZURE
•CRIMINAL
PROSECUTION
CDER
INTRODUCTION
(Center for Drug Evaluation and Research)
CDER INTRODUCTION
The Center for Drug Evaluation and Research
 CDER’S JOB IS TO ENSURE THAT DRUGS ARE
SAFE AND EFFECTIVE.
CDER CONDUCTS LIMITED RESEARCH IN THE
AREAS OF DRUG QUALITY, SAFETY, AND
EFFECTIVENESS.
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CDER IS THE LARGEST OF FDA'S FIVE
CENTERS, WITH A STAFF OF ABOUT 1,800.
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CDER HAS RESPONSIBILITY FOR BOTH
PRESCRIPTION AND OVER-THE-COUNTER
DRUGS.
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Federal Food, Drug
and Cosmetic Act 1938
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Pre-Market safety approval of all new drugs
Prohibited false therapeutic claims for drugs
Drugs labeled with adequate directions for safe
use
Food standards “in the interests of consumers”
Cosmetics and medical devices under FDA’s
jurisdiction
New Drug Applications
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Required growth in scientific expertise
Hiring of review scientists
Drug Abuse
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From the 1940s to the 1960s, the abuse of
amphetamines and barbiturates required more
regulatory effort by FDA than all other drug
problems combined
1965 Drug Abuse Control Amendments
brought relief
Drug Regulation Changes
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New drug approvals based on safety AND
efficacy
Required GMPs and later GLPs
New controls over Rx advertising
New patient protection policies
Retrospective reviews of drugs approved for
safely alone between 1938-1960
DESI Drug Review
 OTC Review
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Amendments -1960s
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Kefauver-Harris Amendments-the most
significant changes in the
Food Drug and Cosmetic Act
Premarket efficacy and safety
 Good manufacturing practices
 Prescription drug advertising
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Introduction
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Over-the-counter (OTC) drug products can be
marketed under two regulatory mechanisms:
(1) A new drug application (NDA)
(2) OTC drug monograph system
OTC Drug Monograph System
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The OTC drug review - 1972 - beginning of the
OTC drug monograph system.
FDA - identifying a number of therapeutic
categories to establish OTC drug monographs. –
an alternative for new drug application (NDA).
No need for pre-approval from FDA.
GRASE (generally recognized as safe
and effective )
OTC drug monographs list the following conditions.
The conditions of use include :
 Active ingredients (single or in combination)
 Dosage strength, dosage form (in some cases)
 Indications
 Warnings
 Directions for use
 Final formulation testing.
The OTC drug review is a four step
public rulemaking process:
(1) Advisory Review Panel: The Panel is a group of
experts in a particular OTC drug category.
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The Panel reviews data for OTC drug products
marketed prior to December 1975 and recommends
GRASE conditions for an OTC drug monograph.
The OTC drug review
(2) Advance Notice of Proposed Rulemaking
(ANPR): FDA publishes the ANPR in the
Federal Register to announce its intention of
creating an OTC drug monograph.
The ANPR also contains the Panel’s report, which
lists the recommended GRASE conditions.
 Following publication of the ANPR, interested
persons may submit comments and additional data
regarding the Panel’s recommendations during a 90day comment period.
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The OTC drug review
(3) Tentative Final Monograph (TFM): FDA publishes the
TFM, or proposed rule, in the Federal Register as its
preliminary position regarding the safety and
effectiveness of each active ingredient in a therapeutic
category.
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The TFM is based on FDA’s interpretation of data provided
to the Panel, the Panel’s recommendations, and any new data
submitted in response to the ANPR.
Following publication of the TFM, there is a 90-day
comment period.
The OTC drug review
(4) Final Monograph (FM): FDA reviews all comments
and data submitted during the TFM comment period
and amends the TFM to create the FM, or final rule.
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It is published on Federal Register.
The monograph is a set regulations included in the Code of
Federal Regulations. The FM includes an effective date.
Although the FM is the final step in this OTC drug review
process, FDA can amend the FM to include additional
GRASE conditions (e.g., add a new active ingredient).
Front label
EXTERNAL ANALGESICS
NIAVIN TM “PAIN RELIEF”
TRIGGER POINT RELIEF – DRY BODY OIL
DOCTOR RECOMMENDED PAIN RELIEF
External use only
Net weight: 2 x 0.3 oz (2 x 10 ml), 2 vials per package
Product of South Africa
For relief of arthritis, Muscle, and Joint Pains
DRUG FACTS
Active ingredients:
PURPOSE
Methyl salicylate – 10% EXTERNAL ANALGESIC
Inactive ingredients: C12-15 Alkyl benzoate, Fragrance, Juniperus ashei oil
USES for the temporary relief of minor aches and pains of muscles and joints
associated with simple backache, arthritis and strains.
Warnings – Do not use if the seal is broken. Use only as directed. For external use
only. Avoid contact with eyes, mucous membranes, rashes, wounds, or damaged skin,
do not use with a heated pad, keep away from children. Package not child resistant, in
case of accidental ingestion, contact a doctor immediately, if prone to allergic reaction
to the product, consult to a doctor before using. If rashes, redness or itchiness results,
discontinue use and consult a doctor. If pregnant or breast-feeding, ask a health
professional before use.
Direction:
Adult and children 10 years of age and older: apply to
affected area and rub gently 3 to 4 times daily. Children
under 10 years old of age: do not use, consult a doctor.
For more information and detailed instructions about
proper use of NIAVIN Trigger Point Relief™, please visit
us at: www.niavin.com.
For other inquiries, call: 1-800-471-1036
Storage: The container should be kept closed tightly all
the time, This product should be kept in a cool place and
away from any heating sources.
Distributed by: Niavin Corporation
Northridge, CA 91343
COSMETIC PRODUCT
REGULATION
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COSMETIC SAFETY
COSMETIC INGREDIENTS
COMETIC LABELING
COSMETIC / DRUG DUAL IDENTIRY
COSMETIC DEFINITION
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The FD&C Act defines cosmetics as articles intended
to be applied to the human body for cleansing,
beautifying, promoting attractiveness, or altering the
appearance without affecting the body's structure or
functions
- skin creams, lotions, perfumes, lipsticks, fingernail
polishes, eye and facial make-up preparations,
shampoos, permanent waves, hair colors, toothpastes,
deodorants, and any material intended for use as a
component of a cosmetic product.
DRUG / COSMETICS DUAL
IDENTITY
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Examples of products which are drugs as well as
cosmetics are anticaries toothpastes (e.g.,
"fluoride" toothpastes), hormone creams,
suntanning preparations intended to protect
against sunburn, antiperspirants that are also
deodorants, and antidandruff shampoos.
EXAMPLES OF PROBLEMS IN
COSMETICS
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(1) Adulterated. - if it contains a substance which may make the product
harmful to consumers; if it contains a filthy, putrid, or decomposed
substance; if it is manufactured or held under insanitary conditions or if it
is not a hair dye and it contains a non-permitted color additive.
(2) Coal-tar hair dyes bearing on the label the caution statment are exempted
from the adulteration provision even if they are irritating to the skin or are
otherwise harmful to the human body.
(3) Eyelash and eyebrow dyes are not included in this exemption.
All dyes used in eyelash and eyebrow dye products must be approved by
the FDA for such use.
(4) A cosmetic is misbranded if its labeling is false or misleading, if it does not
bear the required labeling information, or if the container is made or filled
in a deceptive manner.
Issues with Cosmetic Product
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1. Formulation (ingredients used)
2. Label decoration
3. Tamper-resistant packaging
4. Label warning
5. microbial and chemical testing
6. Safety test (e. g. skin allergy)
Drug Facts
OTC DRUG REGISTRATION
AND LISTING
1) REGISTRATION:
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MANUFACTURER
EXPORTER
IMPORTER
2) LISTING
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PRODUCT NAME
PACKAGING
DOSAGE
METHOD OF ADMINISTRATION
FORMULATION
USGAE
DRUG LABELING
NDC (NATIONAL DRUG CODE) APPLICATION
OTC DRUG WITH CHINESE
HERBAL MEDICINE
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LIMITATIONS:
ACTIVE INGREDIENT LABELING
 MEDICAL CLAIM
 CERTAIN COMPONETS ARE NOT
COMPTATIBLE
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OTC DRUG GMP
I. Introduction (1)
A.
Objective (1.1)
B.
Regulatory Applicably (1.2)
C.
Scope (1.3)
II. Quality Management (2)
A.
Principles (2.1)
B.
Responsibilities of the Quality Unit(s) (2.2)
C.
Responsibility for Production Activities (2.3)
D.
Internal Audits (Self Inspection) (2.4)
E.
Product Quality Review (2.5)
OTC DRUG GMP
III. Personnel (3)
 Personnel Qualifications (3.1)
 Personnel Hygiene (3.2)
 Consultants (3.3)
IV. Buildings and Facilities (4)
 Design and Construction (4.1)
 Utilities (4.2)
 Water (4.3)
 Containment (4.4)
 Lighting (4.5)
 Sewage and Refuse (4.6)
A. Sanitization and Maintenance (4.7)
OTC DRUG GMP
V. Process Equipment (5)
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Design and Construction (5.1)
Equipment Maintenance and Cleaning (5.2)
Calibration (5.3)
Computerized Systems (5.4)
VI. Documentation and Records (6)
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A.
Documentation System and Specifications (6.1)
Equipment Cleaning and Use Record (6.2)
Records of Raw Materials, Intermediates, API Labeling and Packaging
Materials (6.3)
Master Production Instructions (Master Production and Control Records)
(6.4)
Batch Production Records (Batch Production and Control Records) (6.5)
Laboratory Control Records (6.6)
Batch Production Record Review (6.7)
OTC DRUG GMP
VII. MATERIALS MANAGEMENT (7)
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General Controls (7.1)
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Receipt and Quarantine (7.2)
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Sampling and Testing of Incoming Production Materials (7.3)
Storage (7.4)
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Re-evaluation (7.5)
VIII. PRODUCTION AND IN-PROCESS CONTROLS (8)
A.
Production Operations (8.1)
B.
Time Limits (8.2)
C.
In-process Sampling and Controls (8.3)
D.
Blending Batches of Intermediates or APIs (8.4)
E.
Contamination Control (8.5)
OTC DRUG GMP
IX. Packaging and Identification labeling of
APIs and Intermediates (9)
 General (9.1)
 Packaging Materials (9.2)
 Label Issuance and Control (9.3)
 Packaging and Labeling Operations (9.4)
X. Storage and distribution (10)
 Warehousing Procedures (10.1)
 Distribution Procedures (10.2)
OTC DRUG GMP
XI. Laboratory Controls (11)
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General Controls (11.1)
Testing of Intermediates and APIs (11.2)
Validation of Analytical Procedures - See Section 12. (11.3)
Certificates of Analysis (11.4)
Stability Monitoring of APIs (11.5)
Expiry and Retest Dating (11.6)
Reserve/ Retention Samples (11.7)
XII. Validation (12)
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A.
Validation Policy (12.1)
Validation Documentation (12.2)
Qualification (12.3)
Approaches to Process Validation (12.4)
Process Validation Program (12.5)
Periodic Review of Validated Systems (12.6)
Cleaning Validation (12.7)
Validation of Analytical Methods (12.8)
OTC DRUG GMP
XIII.
XIV.
A.
B.
C.
D.
E.
Change Controls (11)
Rejection and Re-use of materials (14)
Rejection (14.1)
Reprocessing (14.2)
Reworking (14.3)
Recovery of Materials and Solvents (14.4)
Returns (14.5)
OTC DRUG GMP
XV.
XVI.
XVII.
A.
B.
C.
D.
E.
F.
G.
H.
Complaints and Recalls (15)
Contract Manufacturers (Including Laboratories) (16)
Agents, Brokers, Traders, Distributors, Re packers, and
Re labellers (17)
Applicability (17.1)
Traceability of Distributed APIs and Intermediates (17.2)
Quality Management (17.3)
Repackaging, Re labeling, and Holding of APIs and
Intermediates (17.4)
Stability (17.5)
Transfer of Information (17.6)
Handling of Complaints and Recalls (17.7)
Handling and Returns (17.8)
ENFORCEMENT ON OTC DRUG /
COSMETIC PRODUCT / PRODUCT
WITH D/C DUAL IDENTITY
1.
2.
3.
Enforcement on OTC drugs – No reconditioning allowed,
very strict.
Enforcement on cosmetic product - reconditioning allowed.
Enforcement on D/C dual identity – It depends
HOW TO MARKET DRUG /
COSMETIC PRODUCTS IN U.S.
PRODUCT DEVELOPMENT
HOW TO DIESTRIBUTE YOUR PRODUCTS?
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DISTRIBUTORS
BROKERS
BRANCH OFFICE
INTERNET SALES
HOW TO MARKET DRUG /
COSMETIC PRODUCTS IN U.S.
EFFECTIVE CHANNELS FOR
PENETRATING U. S.
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MARKET
SUPERMARKET
SPECIALTY CHAIN STORES
PHARMACY
LARGE DEPARTMENT STORES
INSTITUTIONAL BUYERS