DAFTAR ISI

LEMBAR PENGESAHAN ......................................................................... i

KATA PENGANTAR ................................................................................ ii
DAFTAR ISI .............................................................................................. iv
DAFTAR LAMPIRAN ............................................................................... viii
BAB I ......................................................................................................... 1
PENDAHULUAN ...................................................................................... 1
1.1 Latar Belakang ................................................................................. 1
1.2 Tujuan .............................................................................................. 3
1.3 Manfaat ............................................................................................ 3
BAB II ........................................................................................................ 4
TINJAUAN PEDAGANG BESAR FARMASI ........................................... 4
2.1 Tinjauan Umum ................................................................................ 4
2.1.1 Pengertian Pedagang Besar Farmasi ........................................ 4
2.1.2 Dasar hukum PBF ................................................................... 5
2.1.3 Tugas dan Fungsi Pedagang Besar Farmasi ............................. 5
2.1.4 Persyaratan Mendirikan Pedagang Besar Farmasi (PBF) ................ 6
2.1.5 Pemberian Izin Pedagang Besar Farmasi ................................. 7
2.1.6 Syarat Gudang di Pedagang Besar Farmasi ............................. 10
2.1.7 Syarat Gudang di Pedagang Besar Farmasi ............................. 10
2.1.8 Pelaporan Pedagang Besar Farmasi ......................................... 11
2.1.9 Cara Distribusi Obat Yang Baik……………..………………..12
2.1.10 Aspek-aspek Dalam CDOB…………………...……………..13
2.3 Manajemen mutu .............................................................................. 14
2.4 Organisasi, Manajemen , dan Personalia ........................................... 14
2.5 Bangunan dan Peralatan ......................................................................15
2.6 Operasional...........................................................................................16
2.7 Inspeksi Diri..........................................................................................17

iv
 2.8 Keluhan Obat dan atau Bahan Obat Kembalian, Diduga Palsu dan
Penarika Kembalian…...……………………………….……………….18
2.9 Transportasi…….………………………………………………………20
2.10 Fasilitas Distribusi Berdasarkan Kontrak ............................................ 20
2.11 Dokumentasi ........................................................................................21
2.12 Ketentuan Khusus Bahan Obat ........................................................... 21
2.13 Ketentuan Khusus Produk Rantai Dingin …………………………...22
2.14 Ketentuan Khusus Narkotika, Psikotropika dan Prekursor ……….....25
2.15 Pengelolaan dan Perbekalan Farmasi...................................................25
BAB III....................................................................................................... 27
TUGAS KHUSUS PEMUSNAHAN OBAT ............................................... 27
LAPORAN PEMUSNAHAN OBAT……………………………………….27
3.1 Pendahuluan ..................................................................................... 27
3.2 Metode Pemusmahan ........................................................................ 27
3.3 Prosedur pemusnahan obat…………………………………………...29
3.4 Tata Cara Pemusnahan Obat.........................................................................30
3.5 Faktor penyebab ...........................................................................................31

BAB IV ...................................................................................................... 32
PENUTUP .................................................................................................. 32
4.1 Kesimpulan ...................................................................................... 32
4.2 Saran ................................................................................................ 32
DAFTAR PUSTAKA ................................................................................. 33
LAMPIRAN 1 ............................................................................................ 34

v
 DAFTAR LAMPIRAN
LAMPIRAN 2 Gambar .............................................................................. 35

vi