Drug Storage and Dispensing Regulations
Schedule X and P
Schedule P:
Schedule P describes the life period of drugs in months
(unless otherwise specified) between date of manufacture
and date of expiry which the labelled potency period of the
drug shall not exceed under the conditions of storage
specified in column no. 4 of schedule P.
The term “cool place” means place having a temperature
between 10
0
C and 25
0
C.
The term “cold place” means a place having a temperature
not exceeding 8
0
C
.
Capsules should be kept in a well-closed container at
temperature not exceeding 30
0
C.
Wherever condition of storage is not specified it may be
stored under normal room temperature.
Schedule P1:
Schedule P1 describes the Pack size of drugs.
Schedule P1 contains Name of drug, their
dosage form and pack size of listed drugs.
Schedule X:
Schedule X describes the habit forming and narcotics drugs list.
Dispensing:
The person dispensing a prescription containing a drug specified in
Schedule H
and
Schedule H1
and Schedule X shall comply with the
following requirements in addition to other requirement of these
rules.
The prescription must not be dispensed more than once unless the
prescriber has stated thereon that it may be dispensed more than
once
If the prescription contains a direction that it may be dispensed a
stated number of times or at stated intervals it must not be
dispensed otherwise than in accordance with the directions;
At the time of dispensing there must be noted on the prescription
above the signature of the prescriber the name and address of the
seller and the date on which the prescription is dispensed.
Conditions:
Substances specified in Schedule H and Schedule H1 or
Schedule X shall not be sold by retail except on and in
accordance with the prescription of a Registered Medical
Practitioner and in the case of substances specified in
Schedule X, the prescriptions shall be in duplicate, one
copy of which shall be retained by the licensee for a
period of two years.
The supply of drugs specified in Schedule H and Schedule
H1 or Schedule X to Registered Medical Practitioners,
Hospitals, Dispensaries and Nursing Homes shall be made
only against the signed order in writing which shall be
preserved by the licensee for a period of two years
List of Schedule X Drugs:
Schedule X describes the list of drugs that covered in schedule
Amobarbital
Amphetamine
Methylphenidate
Barbital
Methylphenobarbital
Cyclobarbital
Pentobarbital
Dexamphetamine
Phencyclidine
Ethclorvynol
Phenometrazine
Glutethimide
Meprobamate
Secobarbital
Methamphetamine
Storage of Schedule X Drugs:
Substances specified in Schedule X kept in retail shop or
premises used in connection therewith shall be stored:
(a) under lock and key in cupboard or drawer reserved
solely for the storage of these substances; or
(b) in a part of the premises separated from the
remainder of the premises and to which only responsible
persons have access
Advertisement:
No advertisement of the drugs specified in Schedule H, Schedule
H1 and Schedule X shall be made except with the previous
sanction of the Central Government
Descriptions and guidelines for Schedule X, Schedule P, Schedule P1, dispensing prescriptions, drug storage conditions, and requirements for selling substances specified in Schedules H, H1, and X. Includes details on drug potency, storage temperatures, pack sizes, habit-forming drugs, and narcotics. Emphasizes the importance of compliance with regulations in handling and dispensing drugs.
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Presentation Transcript
Schedule P: Schedule P describes the life period of drugs in months (unless otherwise specified) between date of manufacture and date of expiry which the labelled potency period of the drug shall not exceed under the conditions of storage specified in column no. 4 of schedule P.
The term coolplace means place having a temperature between 100C and 250C. The term coldplace means a place having a temperature not exceeding 80C. Capsules should be kept in a well-closed container at temperature not exceeding 30 0C. Wherever condition of storage is not specified it may be stored under normal room temperature.
Schedule P1: Schedule P1 describes the Pack size of drugs. Schedule P1 contains Name of drug, their dosage form and pack size of listed drugs.
Schedule X: Schedule X describes the habit forming and narcotics drugs list. Dispensing: The person dispensing a prescription containing a drug specified in Schedule H and Schedule H1 and Schedule X shall comply with the following requirements in addition to other requirement of these rules.
The prescription must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed more than once If the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals it must not be dispensed otherwise than in accordance with the directions; At the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed.
Conditions: Substances specified in Schedule H and Schedule H1 or Schedule X shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner and in the case of substances specified in Schedule X, the prescriptions shall be in duplicate, one copy of which shall be retained by the licensee for a period of two years. The supply of drugs specified in Schedule H and Schedule H1 or Schedule X to Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be made only against the signed order in writing which shall be preserved by the licensee for a period of two years
List of Schedule X Drugs: Schedule X describes the list of drugs that covered in schedule Amobarbital Amphetamine Methylphenidate Barbital Methylphenobarbital Cyclobarbital Pentobarbital Dexamphetamine Phencyclidine Ethclorvynol Phenometrazine Glutethimide Meprobamate Secobarbital Methamphetamine
Storage of Schedule X Drugs: Substances specified in Schedule X kept in retail shop or premises used in connection therewith shall be stored: (a) under lock and key in cupboard or drawer reserved solely for the storage of these substances; or (b) in a part of the premises separated from the remainder of the premises and to which only responsible persons have access
Advertisement: No advertisement of the drugs specified in Schedule H, Schedule H1 and Schedule X shall be made except with the previous sanction of the Central Government
